PREVENTOMICS H2020
Published July 5, 2022 | Version v1
Journal article Open

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

Creators

  • 1. Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark
  • 2. R&D, Food & Culinary Department, Simple Feast, Copenhagen, Denmark
  • 3. 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 Nutrici on (CIBEROBN), Aliment omica S.L., Spin-off n.1 of the UIB Islands, Spain
  • 4. Human Nutrition Unit, Department of Food and Drug, University of Parma, Parma, Italy
  • 5. ONMI: Behaviour Change Technology, Eindhoven, the Netherlands
  • 6. R&D Department, Food Division, Grupo Carinsa, Sant Quirze del Valles, Barcelona, Spain
  • 7. Eurecat, Centre Tecnologic de Catalunya, Centre for Omic Sciences (COS), Joint Unit Universitat Rovira I Virgili-EURECAT, 43204 Reus, Spain
  • 8. Eurecat, Centre Tecnol ogic de Catalunya, Biotechnology Area, Nutrition and Health Unit, Reus, Spain
  • 9. Eurecat, Centre tecnologic de Catalunya, Digital Health Unit, Carrer de Bilbao, 72, 08005 Barcelona, Spain
  • 10. Eurecat, Centre Tecnologic de Catalunya, Biotechnology Area, Nutrition and Health Unit, Reus, Spain
  • 11. Department of Endocrinology, Bispebjerg and Frederiksberg Hospital, Tuborgvej, Hellerup, Denmark
  • 12. Healthy Weight Centre, Novo Nordisk Foundation, Tuborg Havnevej 19, 2900, Hellerup, Denmark

Description

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.govregistry (NCT04590989).

Files

PIIS0261561422002266.pdf

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Additional details

Funding

PREVENTOMICS – Empowering consumers to PREVENT diet-related diseases through OMICS sciences 818318
European Commission