Effects of a low-protein nutritional formula with dietary counseling in older adults with chronic kidney disease stages 3-5: a randomized controlled trial.

Wen-Ching Yang, Hui-Min Hsieh, Jun-Peng Chen, Li-Chun Liu, Cheng-Hsu Chen

Journal: BMC nephrology 2023;24(1):372

PMID: 38097963

Plain Language Summary

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Chronic kidney disease (CKD) is a prevalent clinical issue often observed in older adults. Nutritional management has become essential for older adults with CKD. Recent nutritional guidelines have suggested that a low-protein diet (LPD) can be prescribed. The aim of this study was to compare the effects of a regular LPD alone or a 6% LPF combined with a regular LPD prescription on nutrition status, physical performance, and clinical parameter changes in older adults with CKD stages 3–5. This study was a single-centre, two-armed, open-label, parallel, randomised controlled clinical trial. Participants were allocated at a 1:1 ratio - (1) the control group, patients received a regular LPD prescription; (2) the intervention group, patients received a regular LPD prescription with 6% LPF. Results showed that an LPD plus a 6% LPF provided no changes in energy and protein intake while increasing fatty acid and specific micronutrient intake during the 3-month follow-up period. Furthermore, blood urea nitrogen (clinical parameter) was significantly reduced in the intervention group over three months. Authors concluded that an LPD prescription with a 6% LPF can delay physical performance deterioration and increase micronutrient intake in three months compared to LPD education alone in older adults with CKD stages 3–5.

Abstract

BACKGROUND

Although combining a low-protein diet (LPD) with oral nutritional supplements increases treatment adherence and nutritional status in patients with chronic kidney disease (CKD), the effect of this combination approach in older adults remains unclear. This study examined the impact of a 6% low-protein formula (6% LPF) with diet counseling in older adults with stage 3-5 CKD.

METHODS

In this three-month randomized controlled study, 66 patients (eGFR < 60 mL/min/1.73 m, non-dialysis, over 65 years of age) were randomly assigned to an intervention group (LPD plus a 6% LPF) or control group (LPD alone). The 6% LPF comprised 400 kcal, 6 g of protein, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and various micronutrients. All data were collected at baseline and after three months, including physical performance based on hand grip strength (HGS) and gait speed, nutritional status using Mini Nutritional Assessment-Short Form (MNA-SF) scores, body composition through bioelectrical impedance analysis, and dietary intake from 24-h dietary records.

RESULTS

This study incorporated 47 participants (median age, 73; median eGFR, 36 ml/min/1.73 m; intervention group: 24; control group: 23). The intervention group exhibited significant differences in HGS and gait speed, and micronutrient analysis revealed significantly higher monounsaturated fatty acids (MUFA), EPA, DHA, calcium, iron, zinc, copper, thiamine, riboflavin, niacin, B6, B12, and folic acid intake than the control group. MNA-SF scores, macronutrient intake, and body composition did not differ significantly between the two groups.

CONCLUSIONS

Compared to LPD counseling alone, an LPD prescription with 6% LPF in older adults with CKD stages 3-5 helped relieve physical deterioration and increased micronutrient intake after three months.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05318014 (retrospectively registered on 08/04/2022).

© 2023. The Author(s).

Address: Department of Food and Nutrition, Taichung Veterans General Hospital, Taichung, Taiwan.; Biostatistics Group, Department of Medical Research, Taichung Veterans General Hospital, Taichung, Taiwan.; Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital, No. 1650, Sect. 4, Taiwan Boulevard, Taichung, Taiwan. [email protected].; Department of Post-Baccalaureate Medicine, College of Medicine, National Chung Hsing University School of Medicine, Taichung, Taiwan. [email protected].; Department of Life Science, Tunghai University, Taichung, Taiwan. [email protected].; Program in Tissue Engineering and Regenerative Medicine, College of Medicine, National Chung-Hsing University, Taichung, Taiwan. [email protected].

Patient Centred Factor

Laboratory Testing

Modifiable Lifestyle Factors

Jadad Score

Allocation Concealment

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