A double-blinded, randomized, parallel intervention to evaluate biomarker-based nutrition plans for weight loss: The PREVENTOMICS study.

Mona A Aldubayan, Kristina Pigsborg, Sophia M O Gormsen, Francisca Serra, Mariona Palou, Sebastià Galmés, Andreu Palou-March, Claudia Favari, Mart Wetzels, Alberto Calleja, Miguel Angel Rodríguez Gómez, María Guirro Castellnou, Antoni Caimari, Mar Galofré, David Suñol, Xavier Escoté, Juan María Alcaide-Hidalgo, Josep M Del Bas, Biotza Gutierrez, Thure Krarup, Mads F Hjorth, Faidon Magkos

Journal: Clinical nutrition (Edinburgh, Scotland) 2022;41(8):1834-1844

PMID: 35839545

Free Full Text on Elsevier Science View on PubMed

Plain Language Summary

Obesity, and particularly abdominal adiposity, is associated with various metabolic abnormalities. Diet has a vital role in preventing and managing obesity, but evidence from clinical studies demonstrates there is a great interindividual variability in response to the same dietary intervention, which likely indicates that no one diet is superior to another. The aim of this study was to examine the efficacy of the PREVENTOMICS (empowering consumers to PREVENT diet-related diseases through OMICS sciences) platform, incorporated in an e-commerce digital tool, for producing more favourable health outcomes over dietary plans based on general diet recommendations, in subjects with overweight or obesity and elevated waist circumference. This study is a 10-week randomised single-centre, parallel-group, double-blinded intervention study. Participants were allocated in a 1:1 ratio, stratified by cluster to either the intervention group (personalised plan) or the control group (generic recommendations). Results show that there isn’t any additional benefit of personalising dietary plans, over a generic approach, on the change in fat mass and body weight in individuals with overweight or obesity and elevated waist circumference. Accordingly, personalisation of the diet did not significantly improve health parameters beyond the changes induced by the control diet. Participants in both groups lost approximately 3 kg of body weight. Authors conclude that based on their findings evidence to translate personalised nutrition approaches into clinical practice is insufficient.

Abstract

BACKGROUND & AIMS

Growing evidence suggests that biomarker-guided dietary interventions can optimize response to treatment. In this study, we evaluated the efficacy of the PREVENTOMCIS platform-which uses metabolomic and genetic information to classify individuals into different 'metabolic clusters' and create personalized dietary plans-for improving health outcomes in subjects with overweight or obesity.

METHODS

A 10-week parallel, double-blinded, randomized intervention was conducted in 100 adults (82 completers) aged 18-65 years, with body mass index ≥27 but <40 kg/m, who were allocated into either a personalized diet group (n = 49) or a control diet group (n = 51). About 60% of all food was provided free-of-charge. No specific instruction to restrict energy intake was given. The primary outcome was change in fat mass from baseline, evaluated by dual energy X-ray absorptiometry. Other endpoints included body weight, waist circumference, lipid profile, glucose homeostasis markers, inflammatory markers, blood pressure, physical activity, stress and eating behavior.

RESULTS

There were significant main effects of time (P < 0.01), but no group main effects, or time-by-group interactions, for the change in fat mass (personalized: -2.1 [95% CI -2.9, -1.4] kg; control: -2.0 [95% CI -2.7, -1.3] kg) and body weight (personalized: -3.1 [95% CI -4.1, -2.1] kg; control: -3.3 [95% CI -4.2, -2.4] kg). The difference between groups in fat mass change was -0.1 kg (95% CI -1.2, 0.9 kg, P = 0.77). Both diets resulted in significant improvements in insulin resistance and lipid profile, but there were no significant differences between groups.

CONCLUSION

Personalized dietary plans did not result in greater benefits over a generic, but generally healthy diet, in this 10-week clinical trial. Further studies are required to establish the soundness of different precision nutrition approaches, and translate this science into clinically relevant dietary advice to reduce the burden of obesity and its comorbidities.

CLINICAL TRIAL REGISTRY

ClinicalTrials.gov registry (NCT04590989).

Address: Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark; King Saud bin Abdulaziz University for Health Sciences, College of Applied Medical Sciences, Riyadh, Saudi Arabia.; Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark.; R&D, Food & Culinary Department, Simple Feast, Copenhagen, Denmark.; Laboratory of Molecular Biology, Nutrition and Biotechnology (Nutrigenomics, Biomarkers and Risk Evaluation-NuBE), University of the Balearic Islands (UIB), Health Research Institute of the Balearic Islands (IdISBa), CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Alimentómica S.L., Spin-off n.1 of the UIB Islands, Spain.; Human Nutrition Unit, Department of Food and Drug, University of Parma, Parma, Italy.; ONMI: Behaviour Change Technology, Eindhoven, the Netherlands.; R&D Department, Food Division, Grupo Carinsa, Sant Quirze del Valles, Barcelona, Spain.; Eurecat, Centre Tecnològic de Catalunya, Centre for Omic Sciences (COS), Joint Unit Universitat Rovira I Virgili-EURECAT, 43204 Reus, Spain.; Eurecat, Centre Tecnològic de Catalunya, Biotechnology Area, Nutrition and Health Unit, Reus, Spain.; Eurecat, Centre tecnològic de Catalunya, Digital Health Unit, Carrer de Bilbao, 72, 08005 Barcelona, Spain.; Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark; Department of Endocrinology, Bispebjerg and Frederiksberg Hospital, Tuborgvej, Hellerup, Denmark.; Healthy Weight Centre, Novo Nordisk Foundation, Tuborg Havnevej 19, 2900, Hellerup, Denmark.; Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark. Electronic address: [email protected].

DOI: 10.1016/j.clnu.2022.06.032