-
1.
Effect of probiotic supplements in women with gestational diabetes mellitus on inflammation and oxidative stress biomarkers: a randomized clinical trial.
Hajifaraji, M, Jahanjou, F, Abbasalizadeh, F, Aghamohammadzadeh, N, Abbasi, MM, Dolatkhah, N
Asia Pacific journal of clinical nutrition. 2018;27(3):581-591
-
-
-
Free full text
Plain language summary
Gestational diabetes mellitus (GDM) is a common metabolic condition in pregnancy in which the pregnant woman has high serum glucose levels during gestation. It is characterised by maternal insulin resistance and is associated with inflammation throughout gestation. The aim of this study was to measure the effect of a probiotic supplement capsule containing four bacterial strains in comparison with a placebo on inflammatory and oxidative stress biomarkers among women with newly diagnosed GDM. This study is a randomised controlled trial. The patients were randomly allocated to receive either a probiotic supplement or a placebo capsule once a day for eight weeks. Results show that both inflammatory and oxidative stress biomarkers improved after the use of the probiotic supplement when compared to the placebo. The differences for two of the three inflammatory biomarkers (C-reactive protein and tumour necrosis factor-α) were statistically significant. The levels for the biomarker interlukin-6 did not change significantly between groups. Authors conclude that a probiotic supplement (containing L.acidophilus LA-5, Bifidobacterium BB-12, S.thermophilus STY-31 and L.delbrueckii bulgaricus LBY-2) improves several inflammatory and oxidative stress biomarkers in women with GDM.
Abstract
BACKGROUND AND OBJECTIVES Very little is known about the use of probiotics among pregnant women with gestational diabetes mellitus (GDM) especially its effect on oxidative stress and inflammatory indices. The aim of present study was to measure the effect of a probiotic supplement capsule on inflammation and oxidative stress biomarkers in women with newly-diagnosed GDM. METHODS AND STUDY DESIGN 64 pregnant women with GDM were enrolled in a double-blind placebo controlled randomized clinical trial in the spring and summer of 2014. They were randomly assigned to receive either a probiotic containing four bacterial strains of Lactobacillus acidophilus LA-5, Bifidobacterium BB-12, Streptococcus Thermophilus STY-31 and Lactobacillus delbrueckii bulgaricus LBY-27 or placebo capsule for 8 consecutive weeks. Blood samples were taken pre- and post-treatment and serum indices of inflammation and oxidative stress were assayed. The measured mean response scales were then analyzed using mixed effects model. All statistical analysis was performed using Statistical Package for Social Sciences (SPSS) software (version 16). RESULTS Serum high-sensitivity C-reactive protein and tumor necrosis factor-α levels improved in the probiotic group to a statistically significant level over the placebo group. Serum interleukin-6 levels decreased in both groups after intervention; however, neither within group nor between group differences interleukin-6 serum levels was statistically significant. Malondialdehyde, glutathione reductase and erythrocyte glutathione peroxidase levels improved significantly with the use of probiotics when compared with the placebo. CONCLUSIONS The probiotic supplement containing L.acidophilus LA- 5, Bifidobacterium BB- 12, S.thermophilus STY-31 and L.delbrueckii bulgaricus LBY-2 appears to improve several inflammation and oxidative stress biomarkers in women with GDM.
-
2.
Metabolic Slowing and Reduced Oxidative Damage with Sustained Caloric Restriction Support the Rate of Living and Oxidative Damage Theories of Aging.
Redman, LM, Smith, SR, Burton, JH, Martin, CK, Il'yasova, D, Ravussin, E
Cell metabolism. 2018;27(4):805-815.e4
-
-
-
Free full text
Plain language summary
Following a calorie-restricted diet while maintaining adequate nutrition is known to have a beneficial effect on increasing longevity and promoting healthy ageing. Oxidative stress resulting from reactive oxygen species formation in mitochondria plays a role in accelerating ageing by damaging DNA, proteins and lipids. A calorie-restriction diet can reduce oxidative stress and cause metabolic adaptations. In this ancillary study, non-obese participants were randomly assigned to either a calorie restriction group which followed 25% calorie restriction while getting adequate nutritional support through supplementation or to a control group which included ad libitum calorie intake. After 2 years of intervention, participants in the calorie restriction group achieved 15% calorie restriction, 8.7kg weight loss and a reduction in 24-hour energy expenditure and sleep energy expenditure beyond weight loss because of metabolic adaptation. Oxidative stress and thyroid axis activity were also reduced in the calorie restriction group. Further robust studies are required to evaluate the effectiveness of calorie restriction in metabolic adaptation and oxidative stress and its effects on ageing. The results of this study can be used by healthcare professionals to understand the benefits of a nutritionally adequate calorie restriction diet on adjusting metabolic processes.
Abstract
Calorie restriction (CR) is a dietary intervention with potential benefits for healthspan improvement and lifespan extension. In 53 (34 CR and 19 control) non-obese adults, we tested the hypothesis that energy expenditure (EE) and its endocrine mediators are reduced with a CR diet over 2 years. Approximately 15% CR was achieved over 2 years, resulting in an average 8.7 kg weight loss, whereas controls gained 1.8 kg. In the CR group, EE measured over 24 hr or during sleep was approximately 80-120 kcal/day lower than expected on the basis of weight loss, indicating sustained metabolic adaptation over 2 years. This metabolic adaptation was accompanied by significantly reduced thyroid axis activity and reactive oxygen species (F2-isoprostane) production. Findings from this 2-year CR trial in healthy, non-obese humans provide new evidence of persistent metabolic slowing accompanied by reduced oxidative stress, which supports the rate of living and oxidative damage theories of mammalian aging.
-
3.
A lecithin phosphatidylserine and phosphatidic acid complex (PAS) reduces symptoms of the premenstrual syndrome (PMS): Results of a randomized, placebo-controlled, double-blind clinical trial.
Schmidt, K, Weber, N, Steiner, M, Meyer, N, Dubberke, A, Rutenberg, D, Hellhammer, J
Clinical nutrition ESPEN. 2018;24:22-30
-
-
-
Free full text
Plain language summary
PMS is characterized by a cluster of somatic and psychological symptoms of varying severity. These symptoms occur only during the luteal phase of the menstrual cycle and resolve during the first days of menses. Recent observational data suggest that supplementation with Lipogen's phosphatidylserine and phosphatidic acid complex (PAS) alleviates these PMS symptoms. The aim of this study was to observe the effects of PAS on PMS symptom severity. This study is a prospective, randomised, placebo-controlled, double-blind single centre study with two arms (PAS or placebo). Participants were randomly assigned to one of the two groups. Results show beneficial effects of a daily intake of PAS over 3 cycles on symptom levels as assessed by several well-recognized instruments for PMS evaluation. The PAS complex alleviated the PMS symptoms, providing a safe alternative to standard pharmacological treatment. Authors conclude that their findings merit consideration of developing the PAS complex as a botanical drug for treatment of PMS symptoms.
Abstract
BACKGROUND & AIMS Many women experience emotional and physical symptoms around the time of ovulation and more so before menstruation interfering with their daily normal life also known as premenstrual syndrome (PMS). Recent observational data suggest that supplementation with Lipogen's phosphatidylserine (PS) and phosphatidic acid (PA) complex (PAS) alleviates these PMS symptoms. The aim of this study was to confirm these observations on the effects of PAS on PMS symptom severity within a controlled clinical trial setting. METHODS Forty women aged 18-45 years with a diagnosis of PMS were assigned to either take PAS (containing 400 mg PS & 400 mg PA per day) or a matching placebo. The study comprised 5 on-site visits including 1 baseline menstrual cycle followed by 3 treatment cycles. Treatment intake was controlled for by using an electronic device, the Medication Event Monitoring System (MEMS®). Primary outcome of the study was the PMS symptoms severity as assessed by using the Daily Record of Severity of Problems (DRSP). Further, SIPS questionnaire (a German version of the Premenstrual Symptoms Screening Tool (PSST)), salivary hormone levels (cortisol awakening response (CAR) and evening cortisol levels) as well as serum levels (cortisol, estradiol, progesterone and corticosteroid binding globulin (CBG)) were assessed. RESULTS PMS symptoms as assessed by the DRSP Total score showed a significantly better improvement (p = 0.001) over a 3 cycles PAS intake as compared to placebo. In addition, PAS treated women reported a greater improvement in physical (p = 0.002) and depressive symptoms (p = 0.068). They also reported a lower reduction of productivity (p = 0.052) and a stronger decrease in interference with relationships with others (p = 0.099) compared to the placebo group. No other DRSP scale or item showed significant results. Likewise, the reduction in the number of subjects fulfilling PMS or premenstrual dysphoric disorder (PMDD) criteria as classified by the SIPS did not differ between the PAS and the placebo group. For the biomarkers, the salivary cortisol percentage increase of the CAR was significantly less pronounced in the follicular phase of cycle 4 than in the follicular phase of cycle 1 for subjects taking PAS when compared to subjects taking placebo (p = 0.018). Furthermore, the change of serum cortisol levels between visit 1 and visit 5 differed significantly between groups (p = 0.043). While serum cortisol levels of PAS treated females slightly decreased between visit 1 and visit 5, cortisol levels of females treated with placebo increased. For all other biomarkers, no treatment effects were observed over the 4 cycles study period. Overall, this study confirms that a daily intake of PAS, containing 400 mg PS and 400 mg PA, can be considered as safe. CONCLUSIONS Results substantiate the efficacy of PAS in reducing symptoms of PMS. In view of the recent inclusion of severe PMS symptoms (PMDD) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the positive results of this clinical study merits consideration of developing the PAS complex as a botanical drug for treatment of PMDD. CLINICAL TRIAL REGISTRATION The study is registered at Deutsches Register Klinischer Studien with the registration number DRKS00009005.
-
4.
Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial.
Lean, ME, Leslie, WS, Barnes, AC, Brosnahan, N, Thom, G, McCombie, L, Peters, C, Zhyzhneuskaya, S, Al-Mrabeh, A, Hollingsworth, KG, et al
Lancet (London, England). 2018;391(10120):541-551
-
-
-
Free full text
-
Plain language summary
Most individuals with type 2 diabetes are obese with accumulation of fat around the liver and pancreas. Many studies have demonstrated that dietary induced weight loss can improve type 2 diabetes, however none have assessed whether dietary weight loss can sustain type 2 diabetes remission. This 12-month randomised trial of 306 individuals with type 2 diabetes aimed to determine whether weight management led by doctors would achieve long-term remission of type 2 diabetes. The results showed that weight loss of 15kg or more resulted in significantly higher rates of type 2 diabetes remission after 12 months, with 48% of the weight loss group achieving remission compared to 4% of the individuals who were not assigned a weight loss regimen. It was concluded that nearly half of the participants who were on a dietary weight loss programme achieved type 2 diabetes remission and were able to stop their medications. This study could be used by healthcare professionals to understand that type 2 diabetes remission is a possibility with a supervised dietary weight loss programme.
Abstract
BACKGROUND Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. METHODS We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m2, and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA1c) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. FINDINGS Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8-49·8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0-5 kg weight loss, 19 (34%) of 56 participants with 5-10 kg loss, 16 (57%) of 28 participants with 10-15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10·0 kg (SD 8·0) in the intervention group and 1·0 kg (3·7) in the control group (adjusted difference -8·8 kg, 95% CI -10·3 to -7·3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5-10·3; p=0·0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study. INTERPRETATION Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care. FUNDING Diabetes UK.
-
5.
A 12-Month Lifestyle Intervention Program Improves Body Composition and Reduces the Prevalence of Prediabetes in Obese Patients.
König, D, Hörmann, J, Predel, HG, Berg, A
Obesity facts. 2018;11(5):393-399
-
-
-
Free full text
Plain language summary
Obesity and its impact on the prevalence of diabetes and subsequent cardiovascular disease is one of the major health burdens in Western societies. Lifestyle intervention studies have shown that weight loss combined with increased physical activity can improve metabolic risk factors. The aim of this study was to evaluate the effect of a comprehensive lifestyle intervention programme on weight and metabolic risk factors in 5884 obese individuals. The programme included 61 sessions over 12 months, including 41 exercise sessions, 12 psychological/self-management sessions and 8 nutritional counselling sessions (based on a low glycaemic index, low fat diet). After 12 months there was a significant reduction in weight (average 6%), waist circumference, physical fitness and all metabolic parameters (including blood sugar and fat metabolism). Overall, in 839 (38%) of the 2,227 participants who were pre-diabetic before intervention, the criteria of pre-diabetes were no longer detectable after 12 months, whilst only 66 (3%) progressed to type 2 diabetes mellitus. 46.7% of the 1,641 participants fulfilling the criteria of metabolic syndrome before the intervention, did not show any signs of this syndrome after the intervention; whilst only 120 participants (+7.3%) newly developed metabolic syndrome. The authors concluded that the intensive lifestyle intervention programme was successful, even in obese people with pre-diabetes.
Abstract
BACKGROUND The present study investigated the effects of a 12-month interdisciplinary standardized lifestyle program addressing physical activity and changes in dietary and lifestyle behavior in 2,227 obese prediabetic participants. METHODS Measures of obesity (BMI, waist circumference), cardiopulmonary fitness, and metabolic parameters were determined before and after the intervention period. RESULTS From the 2,227 participants who were initially prediabetic, 839 participants (-37.7%) did no longer show the criteria of prediabetes after the intervention and had normal HbA1c levels. CONCLUSION The clinical effects are substantial, and it is likely that the applied intense and multidisciplinary lifestyle interventions could reduce the risk of developing diabetes and the prevalence of a full-blown metabolic syndrome in obese and prediabetic patients.
-
6.
Men and women respond differently to rapid weight loss: Metabolic outcomes of a multi-centre intervention study after a low-energy diet in 2500 overweight, individuals with pre-diabetes (PREVIEW).
Christensen, P, Meinert Larsen, T, Westerterp-Plantenga, M, Macdonald, I, Martinez, JA, Handjiev, S, Poppitt, S, Hansen, S, Ritz, C, Astrup, A, et al
Diabetes, obesity & metabolism. 2018;20(12):2840-2851
-
-
-
Free full text
-
Plain language summary
Overweight and obesity are major risk factors for developing type 2 diabetes mellitus. Men and women respond differently to weight loss programmes, with men typically losing more weight and more abdominal fat, whilst women lose more subcutaneous fat. The aim of this large multinational study was to compare the effects of weight loss induced by an 8‐week low energy diet on metabolic outcomes in overweight men and women with prediabetes. Study participants followed the Cambridge Weight Plan which is based on four formula meals, with a total of approximately 810kcal, per day, for eight weeks. Small amounts of non-starchy vegetables were allowed, as were psyllium husks in case of digestive problems. Men lost significantly more weight than women, 11.8% versus 10.3%. Insulin resistance improved similarly in men and women, but metabolic syndrome score improved more in men than in women. Men lost more fat than women and generally had more beneficial metabolic changes. Women had higher reductions in fat-free mass, bone mineral content and HDL cholesterol than men, raising the question whether rapid weight loss may have negative longer term effects for women.
Abstract
AIMS: The PREVIEW lifestyle intervention study (ClinicalTrials.gov Identifier: NCT01777893) is, to date, the largest, multinational study concerning prevention of type-2 diabetes. We hypothesized that the initial, fixed low-energy diet (LED) would induce different metabolic outcomes in men vs women. MATERIALS AND METHODS All participants followed a LED (3.4 MJ/810 kcal/daily) for 8 weeks (Cambridge Weight Plan). Participants were recruited from 8 sites in Europe, Australia and New Zealand. Those eligible for inclusion were overweight (BMI ≥ 25 kg/m2 ) individuals with pre-diabetes according to ADA-criteria. Outcomes of interest included changes in insulin resistance, fat mass (FM), fat-free mass (FFM) and metabolic syndrome Z-score. RESULTS In total, 2224 individuals (1504 women, 720 men) attended the baseline visit and 2020 (90.8%) completed the follow-up visit. Following the LED, weight loss was 16% greater in men than in women (11.8% vs 10.3%, respectively) but improvements in insulin resistance were similar. HOMA-IR decreased by 1.50 ± 0.15 in men and by 1.35 ± 0.15 in women (ns). After adjusting for differences in weight loss, men had larger reductions in metabolic syndrome Z-score, C-peptide, FM and heart rate, while women had larger reductions in HDL cholesterol, FFM, hip circumference and pulse pressure. Following the LED, 35% of participants of both genders had reverted to normo-glycaemia. CONCLUSIONS An 8-week LED induced different effects in women than in men. These findings are clinically important and suggest gender-specific changes after weight loss. It is important to investigate whether the greater decreases in FFM, hip circumference and HDL cholesterol in women after rapid weight loss compromise weight loss maintenance and future cardiovascular health.
-
7.
Regaining body weight after weight reduction further increases pulse wave velocity in obese men with metabolic syndrome.
Liang, KW, Lee, WJ, Lee, IT, Lin, SY, Wang, JS, Lee, WL, Sheu, WH
Medicine. 2018;97(40):e12730
-
-
-
Free full text
-
Plain language summary
Atherosclerosis can increase stiffness of the aorta and, therefore, increased pulse wave velocity (PWV), which is a predictor for cardiovascular disease and mortality. Metabolic syndrome (MetS), diabetes and obesity increase the risk of aortic stiffness and higher PWV. Weight loss may reduce arterial stiffness but mechanisms are not known. The aim this study was to investigate changes over time of PWV, ankle-brachial index (ABI, a marker for arterial disease of the leg), insulin resistance and inflammatory markers after weight loss and regained weight in obese non-diabetic men with MetS compared to lean controls. Obese participants followed a three months weight loss programme based on diet and exercise during which they lost an average of 8.6kg and saw statistically significant improvements in blood pressure and many biochemical markers but not in PWV or ABI. At the second follow-up visit, at 60 months, they had regained their weight, blood pressure and most biochemical markers were back to baseline whilst PWV and adiponectin were worse than before weight loss. Increases in blood pressure but not weight, hs-CRP (an inflammatory marker) or insulin resistance correlated with the increase in PWV after weight regain. Although healthy controls also gained weight over the 60 months study duration, their increase in PWV was significantly lower than in obese participants. Their PWV was also lower at baseline.
Abstract
Subjects with metabolic syndrome (MetS) or obesity have worse arterial stiffness. However, there have been no studies addressing time-sequential changes in pulse wave velocity (PWV) after weight loss and then regaining weight in obese non-diabetic men with MetS.We prospectively enrolled 40 obese, non-diabetic men with MetS undergoing a 3-month weight reduction program. Another 26 lean and healthy men were recruited for comparisons. Oral glucose tolerance test and brachial ankle (ba) PWV were assessed in study subjects. Eighteen obese non-diabetic MetS and 15 lean control subjects had follow-ups at the 60th month.The body weight of obese MetS decreased from 94.8 ± 7.6 to 86.1 ± 9.0 (N = 18, P < .001) after a 3-month weight reduction program but regained gradually thereafter to 93.6 ± 11.6 kg at the 60th month (P < .001 versus 3rd month). baPWV decreased after weight loss slightly (P = .240) while weight regain significantly increased the baPWV (from 3rd month, 1358 ± 168 to 60th month 1539 ± 264 cm/sec, P < .001). Systolic and diastolic blood pressure increments correlated with the increment of baPWV after weight regain. At the 60th month, lean controls (N = 15) had increases in body weight while their baPWV increased non-significantly. The increments of baPWV after weight regain in obese MetS were significantly higher than the increment of baPWV in lean controls after weight gain.In conclusion, regaining body weight after weight reduction worsened arterial stiffness with significant increase of baPWV in obese non-diabetic MetS.
-
8.
Evaluation of a 12-week lifestyle education intervention with or without partial meal replacement in Thai adults with obesity and metabolic syndrome: a randomised trial.
Chaiyasoot, K, Sarasak, R, Pheungruang, B, Dawilai, S, Pramyothin, P, Boonyasiri, A, Supapueng, O, Jassil, FC, Yamwong, P, Batterham, RL
Nutrition & diabetes. 2018;8(1):23
-
-
-
Free full text
Plain language summary
Obesity and metabolic syndrome (MetS) have markedly increased in many low- and middle-income countries, such as Thailand, as a consequence of economic growth, increased urbanisation and adoption of a ‘western’ lifestyle. Weight-loss interventions by reducing energy intake and increasing physical activity through behavioural modification are the mainstay of the treatment of obesity and MetS, but poor compliance is a problem. The aim of this randomised study was to evaluate the effect of a low-cost lifestyle education intervention (LEI) alone or a LEI with meal replacements (LEI + MR) in Thai adults with obesity and MetS for 12 weeks. The lifestyle education was delivered by a dietitian and comprised a group session at baseline with advice on diet and physical activity, followed by four individual sessions at weeks 2, 4, 8 and 12. In addition, the LEI + MR group also received two meal replacement formula meals per day. The LEI+MR group lost more weight than the LEI group, 2.86% versus 1.53%. Weight loss was maintained at 26 weeks after the end of the intervention, but had gone back to baseline after another 26 weeks. Overall, the LEI+MR group had better outcomes in blood sugar control and metabolic syndrome scores. The authors conclude that both LEI and LEI + MR are acceptable for Thai patients with obesity and MetS and lead to modest weight loss and improvement in MetS and blood sugar control, with the LEI + MR group showing greater benefits at 12 weeks
Abstract
BACKGROUND/OBJECTIVES There have been no studies examining the efficacy of meal replacement (MR) on weight loss and metabolic syndrome (MS) improvement in Southeast Asians. Thus, we undertook a 12-week randomised trial to evaluate the effect of a lifestyle education intervention alone (LEI) or with partial MR (LEI + MR) in obese Thai adults with MS. SUBJECTS/METHODS A total of 110 patients were randomised to receive either LEI or LEI + MR. Both groups received LEI to achieve weight loss. LEI + MR group additionally received two MR daily to replace either breakfast, lunch or dinner. Mean ± SE body mass index of all participants was 34.6 ± 0.6 kg/m2, mean ± SE age was 42.5 ± 1.1 years and 83% of patients were female. Both groups were compared for anthropometric and cardiometabolic indices at 12-week. Body weight was also compared at weeks 38 and 64. RESULTS At 12 weeks, both groups exhibited statistically significant percentage weight loss (%WL) compared to initial weight but greater %WL was observed in LEI + MR compared to LEI, 2.9% vs. 1.5%, respectively (p < 0.05). MS criteria such as waist circumference and blood pressure improved significantly in both groups compared to baseline. However, improvement in fasting plasma glucose (FPG) was only significant in LEI + MR, and more participants with impaired FPG at baseline in LEI + MR (42.9%) than LEI (19%) returned to normal FPG at 12 weeks (p < 0.05). HbA1c, fasting insulin and HOMA-IR in LEI + MR were significantly lower than with LEI. At the end of the 12-week intervention period, 16% of participants no longer fulfilled MS criteria. A statistically significant weight loss from baseline persisted until 38 weeks but no longer reached statistically significant difference between groups CONCLUSIONS LEI and LEI + MR were acceptable and led to improvement in weight and MS. LEI + MR group exhibited additional weight reduction and glycemic benefits at 12 weeks.
-
9.
Weight loss and metabolic health effects from energy-restricted Mediterranean and Central-European diets in postmenopausal women: A randomized controlled trial.
Bajerska, J, Chmurzynska, A, Muzsik, A, Krzyżanowska, P, Mądry, E, Malinowska, AM, Walkowiak, J
Scientific reports. 2018;8(1):11170
-
-
-
Free full text
Plain language summary
During menopause women commonly gain weight, in particular around the waist. This abdominal obesity is a risk factor for diabetes and heart disease. The aim of this randomised trial in Poland was to compare the effectiveness of two energy-restricted diets on weight loss and metabolic syndrome (MetS) in post-menopausal women with abdominal obesity and at least one other marker for MetS. The diets used were the Mediterranean diet (MED), which is moderate in fat, in particular mono-unsaturated fat, and the so-called Central European diet (CED), which is low in fat, moderate in carbohydrates, and high in dietary fiber (DF) derived from central European food items. Participants were counselled on their respective diet plans and provided with one prepared main meal per day and followed their diet for 16 weeks. Both groups had a significant weight loss (7.5kg MED, 7.7kg CED), reductions in waist circumference (7.4cm both), fat mass and abdominal fat. Both groups also had significant improvements in blood sugar control, blood pressure, homocysteine and triglycerides but not in LDL and HDL cholesterol. There were no significant differences between groups for any of the outcomes. Adherence to the respective diets decreased over the course of the study for both the MED and the CED and weight loss was highest for those who adhered best to the respective diet. The authors concluded that short-term dietary treatment using the CED or the MED was associated with similar improvements in weight and markers of MetS.
Abstract
We conducted a randomized controlled trial to examine the effect of two energy-restricted diets on body weight (BW), visceral fat (VF) loss, and the risk factors for metabolic syndrome. A total of 144 centrally obese postmenopausal women were assigned to the moderate in fat Mediterranean diet (MED) or to the Central European diet (CED), which is moderate in carbohydrates and high in dietary fiber (DF), for 16 weeks. BW, waist circumference and VF were significantly reduced by 8.8%, 7.0%, and 24.6%, respectively, over the trial (P < 0.001), with no difference between groups. A similar trend was seen for total cholesterol, triglycerides, glucose, and blood pressure. Within each diet group, the more adherent participants lost significantly more BW than did their less adherent counterparts. VF was significantly reduced only in women who were more adherent to the CED, and the reduction in VF correlated with an increase in the proportion of DF. Short-term dietary treatment with the CED or the MED was associated with similar improvements in some anthropometric, lipid, and nonlipid parameters; however, adequate adherence to the prescribed diet is important in weight loss success and in achieving improvements in metabolic health.
-
10.
Superiority of magnesium and vitamin B6 over magnesium alone on severe stress in healthy adults with low magnesemia: A randomized, single-blind clinical trial.
Pouteau, E, Kabir-Ahmadi, M, Noah, L, Mazur, A, Dye, L, Hellhammer, J, Pickering, G, Dubray, C
PloS one. 2018;13(12):e0208454
-
-
-
Free full text
Plain language summary
Magnesium (Mg) plays a role in over 600 biochemical reactions. It is depleted during stress, and a lack of Mg increases the release of stress hormones, leading to a vicious cycle of lowered resistance to stress and further Mg depletion. Vitamin B6 influences neurotransmitters involved in depression and anxiety, and may improve the uptake of magnesium into cells. The aim of this randomised control trial was to evaluate the effects of combined magnesium and vitamin B6 supplementation in stressed people with low blood levels of magnesium. 260 adults aged 18-50 completed the 8-week study. At the beginning of the trial, all participants had suboptimal blood serum magnesium (0.45 mmol/L to 0.85 mmol/L) and reported moderate to extremely severe stress levels. Participants were divided into two groups. One group received magnesium supplementation (465mg magnesium lactate dihydrate, equivalent to 300mg elemental magnesium; Mg), whilst the other received a combined magnesium and vitamin B6 supplement (470 mg magnesium lactate dihydrate plus 5 mg pyridoxine hydrochloride; Mg-B6). After 8 weeks, the Mg-B6 group reported a reduction in stress levels of 44.9%, and the Mg group reported a reduction of 42.4%, with no statistical difference between the two groups overall. However, participants who reported severe or extremely severe stress levels at the start of the study experienced 24% greater improvement with Mg-B6 versus Mg. Researchers concluded that in people with low magnesium levels experiencing severe or extremely severe stress, combining vitamin B6 with magnesium appears to be of greater benefit than supplementing Mg alone.
Abstract
INTRODUCTION Animal and clinical studies suggest complementary effects of magnesium and high-dose pyridoxine (vitamin B6) on stress reduction. This is the first randomized trial evaluating the effects of combined magnesium and vitamin B6 supplementation on stress in a stressed population with low magnesemia using a validated measure of perceived stress. METHODS In this Phase IV, investigator-blinded trial (EudraCT: 2015-003749-24), healthy adults with Depression Anxiety Stress Scales (DASS-42) stress subscale score >18 and serum magnesium concentration 0.45 mmol/L-0.85 mmol/L, were randomized 1:1 to magnesium-vitamin B6 combination (Magne B6 [Mg-vitamin B6]; daily dose 300 mg and 30 mg, respectively) or magnesium alone (Magnespasmyl [Mg]; daily dose 300 mg). Outcomes included change in DASS-42 stress subscale score from baseline to Week 8 (primary endpoint) and Week 4, and incidence of adverse events (AEs). RESULTS In the modified intention-to-treat analysis (N = 264 subjects), both treatment arms substantially reduced DASS-42 stress subscale score from baseline to Week 8 (Mg-vitamin B6, 44.9%; Mg 42.4%); no statistical difference between arms was observed (p>0.05). An interaction (p = 0.0097) between baseline stress level and treatment warranted subgroup analysis (as per statistical plan); adults with severe/extremely severe stress (DASS-42 stress subscale score ≥25; N = 162) had a 24% greater improvement with Mg-vitamin B6 versus Mg at Week 8 (3.16 points, 95% CI 0.50 to 5.82, p = 0.0203). Consistent results were observed in the per protocol analysis and at Week 4. Overall, 12.1% of Mg-vitamin B6 treated and 17.4% of Mg-treated subjects experienced AEs potentially treatment related. CONCLUSIONS These findings suggest oral Mg supplementation alleviated stress in healthy adults with low magnesemia and the addition of vitamin B6 to Mg was not superior to Mg supplementation alone. With regard to subjects with severe/extremely severe stress, this study provides clinical support for greater benefit of Mg combined with vitamin B6.