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

Research output: Contribution to journalJournal articleResearchpeer-review


  • 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 Fiil Hjorth

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).

Original languageEnglish
JournalClinical Nutrition
Issue number8
Pages (from-to)1834-1844
Number of pages11
Publication statusPublished - 2022

Bibliographical note

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

    Research areas

  • Faculty of Science - Personalized nutrition, Precision nutrition, Nutrigenetics, Metabolomics, Obesity, Weight management, Health-biomarkers

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