Gene-diet Interactions on Body Weight Regulation and Lifestyle Parameters.

NCT ID: NCT04699448

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-13
• Study Completion Date: 2021-04-14

Brief Summary

Increased body weight leading to the development and the establishment of overweight and obesity, has a growing detrimental effect on overall health status and quality of life. Latest research has been focusing on the direct influence of dietary habits on body weight regulation and its synergistic effect with genetic predisposition. The synergistic effect of genetic makeup and dietary habits constitute a major contributing factor, specifically in its manifestation on parameters of the cardiometabolic profile of individuals with elevated body weight.

In this context, the aim of the present study is to investigate the effect of two hypocaloric diets with different macronutrient content (a high-carbohydrate/low-fat and a high-protein one) on the body weight loss of an overweight and/or obese adult, Greek population. Moreover, the study aims to explore gene-diet interactions between obesity and weight loss- related target genes and adherence to the proposed dietary schemes. It will further examine influences of the aforementioned factors on body composition, anthropometric indices, such as waist circumference, biochemical biomarkers related to cardiometabolic control and parameters of lifestyle, such as sleep quality.

More specifically, 300 participants will be allocated into two groups, following either the high-carbohydrate/low-fat diet or the high-protein diet, for a duration of 3 months. Volunteers will participate in in-person meetings, at baseline and at three months after the beginning of the intervention. Anthropometric measurements and collection of blood samples will take place in each meeting. Demographic data and data on family and medical history, dietary habits, adherence to the Mediterranean diet, overall health status and physical activity will be collected at baseline. Participants will be provided with nutritional counselling and support both at the beginning and throughout the intervention. Participants will further report their monthly progress by completing online questionnaires (namely concerning their body weight, overall health status, physical activity and sleep quality), via use of an online assessment tool developed by our team.

The effect of the intervention will be evaluated using anthropometric indices, body composition markers and biochemical biomarkers of cardiometabolic control, pre- and post- intervention. Gene-diet interactions will be assessed via genotyping of DNA samples and statistical analyses will take place via statistical packages, such as PLINK v.1.9.

Conditions

Gene-diet Interactions; Overweight and Obesity; Body Weight Changes; Health Status; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High-protein hypocaloric diet

Composition of hypocaloric diet: protein:40%,carbohydrates:30% and fat:30%.

Group Type: ACTIVE_COMPARATOR

Nutritional intervention.

Intervention Type: OTHER

Diets designed for body weight loss, based on different macronutrient content.

High-carbohydrate hypocaloric diet

Composition of hypocaloric diet: carbohydrate 60%, protein:18% and fat:22%

Group Type: ACTIVE_COMPARATOR

Nutritional intervention.

Intervention Type: OTHER

Diets designed for body weight loss, based on different macronutrient content.

Interventions

Nutritional intervention.

Diets designed for body weight loss, based on different macronutrient content.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women of 18 to 65 years of age.
• Body Mass Index of over 25kg/m2 (presence of overweight or obesity)

Exclusion Criteria

• Pregnancy or lactation.
• Unregulated comorbidities (i.e. type 1 or 2 diabetes, cardiovascular disease, gastrointestinal disorders, mental illness, dietary disorders)
• Dietary supplements aiming at body weight loss
• Parallel participation in a different research study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

GEORGIOS DEDOUSSIS

Professor of Molecular Genetics - Nutrigenetics, Vice Rector of Academic of Affairs and Quality Assurance

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harokopio University

Athens, Kallithea, Greece

Countries

Greece

References

Bray GA, Krauss RM, Sacks FM, Qi L. Lessons Learned from the POUNDS Lost Study: Genetic, Metabolic, and Behavioral Factors Affecting Changes in Body Weight, Body Composition, and Cardiometabolic Risk. Curr Obes Rep. 2019 Sep;8(3):262-283. doi: 10.1007/s13679-019-00353-1.

Reference Type: BACKGROUND

PMID: 31214942 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25673412 (View on PubMed)

Other Identifiers

1800/13-06-2019

Identifier Type: -

Identifier Source: org_study_id