NCT04699448.

Study name	Gene‐diet interactions on body weight regulation and lifestyle parameters (iMPROVE)
Methods	Randomised trial (parallel assignment)
Participants	Men and women, aged 18 to 65 years, with a BMI of > 25 kg/m2. Exclusion criteria included: pregnancy or lactation; the presence of comorbidities such as type 1 or 2 diabetes, cardiovascular disease, gastrointestinal disorders, mental illness or dietary disorders; taking dietary supplements aimed at body weight loss; or parallel participation in a different research study.
Interventions	Intervention ‐ High‐protein hypocaloric diet: 6‐month diet designed for body weight loss. Approximate macronutrient distributions (carbohydrate: protein:fat) will be 30%:40%:30%. Control‐ High‐carbohydrate hypocaloric diet: 6‐month diet designed for body weight loss. Approximate macronutrient distributions (carbohydrate: protein:fat) will be 60%:18%:22%.
Outcomes	Primary outcomes: 1) change in body weight Secondary outcomes: 1) change in body fat percentage, 2) change in waist circumference, 3) change in visceral fat, 4) change in biochemical biomarkers related to metabolic syndrome and cardiovascular disease risk (i.e. total cholesterol, glucose, triglyceride and HDL levels), 5) change in sleep quality, 6) change in depression symptoms, 7) change in overall health status
Starting date	April 2020
Contact information	Prof. Georgios Dedoussis, dedousi@hua.gr and Prof. Andriana Kaliora, akaliora@hua.gr
Notes	Retrospectively registered