TY - JOUR

T1 - A double-blinded, randomized, parallel intervention to evaluate biomarker-based nutrition plans for weight loss: The PREVENTOMICS study

AU - Aldubayan, Mona A

AU - Pigsborg, Kristina

AU - Gormsen, Sophia M O

AU - Serra, Francisca

AU - Palou, Mariona

AU - Galmés, Sebastià

AU - Palou-March, Andreu

AU - Favari, Claudia

AU - Wetzels, Mart

AU - Calleja, Alberto

AU - Rodríguez Gómez, Miguel Angel

AU - Castellnou, María Guirro

AU - Caimari, Antoni

AU - Galofré, Mar

AU - Suñol, David

AU - Escoté, Xavier

AU - Alcaide-Hidalgo, Juan María

AU - M Del Bas, Josep

AU - Gutierrez, Biotza

AU - Krarup, Thure

AU - Hjorth, Mads Fiil

AU - Magkos, Faidon

N1 - Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

PY - 2022

Y1 - 2022

N2 - 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/m2, 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).

AB - 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/m2, 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).

KW - Faculty of Science

KW - Personalized nutrition

KW - Precision nutrition

KW - Nutrigenetics

KW - Metabolomics

KW - Obesity

KW - Weight management

KW - Health-biomarkers

U2 - 10.1016/j.clnu.2022.06.032

DO - 10.1016/j.clnu.2022.06.032

M3 - Journal article

C2 - 35839545

VL - 41

SP - 1834

EP - 1844

JO - Clinical Nutrition

JF - Clinical Nutrition

SN - 0261-5614

IS - 8

ER -