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

Quality of Life Clinical Trial

— iMPROVE  

Official title:

Genetic Predisposition and Body Weight Regulation. Evaluation of Target-genes in Overweight and Obese Adults, Under Different Dietary Interventions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699448
• Other study ID #: 1800/13-06-2019
• Status: Completed
• Phase: N/A
• Start date: April 13, 2020
• Est. completion date: April 14, 2021

Study information

• Verified date: January 2023
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: April 14, 2021
• Est. primary completion date: April 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Nutritional intervention.
Diets designed for body weight loss, based on different macronutrient content.

Locations

Country	Name	City	State
Greece	Harokopio University	Athens	Kallithea

Sponsors (1)

Lead Sponsor	Collaborator
Harokopio University

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. — View Citation

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Changes in body weight compared to baseline.	3 months
Secondary	Body fat percentage	Changes in body fat percentage compared to baseline.	3 months
Secondary	Waist circumference	Changes in waist circumference compared to baseline.	3 months
Secondary	Visceral fat	Changes in visceral fat compared to baseline.	3 months
Secondary	Biochemical profile	Changes in biochemical biomarkers related to metabolic syndrome and cardiovascular disease risk (i.e. total cholesterol, glucose, triglyceride and HDL levels) compared to baseline.	3 months
Secondary	Sleep quality	Changes in sleep quality characteristics compared to baseline. Assessment will take place via use of validated questionnaire.	3 months
Secondary	Overall health status	Changes in the overall health status compared to baseline. Assessment will take place via use of validated questionnaire.	3 months