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

• ClinicalTrials.gov Identifier: NCT04699448
• Recruitment Status: Recruiting
• First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Sponsor: Harokopio University
• Information provided by (Responsible Party): GEORGIOS DEDOUSSIS, Harokopio University

Study Description

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 and depression.

More specifically, 300 participants will be allocated into two groups, following either the high-carbohydrate/low-fat diet or the high-protein diet, for 6 months. Volunteers will participate in three in-person meetings, one at baseline and two follow ups at three and six 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.

Condition or disease	Intervention/treatment	Phase
Gene-diet Interactions; Overweight and Obesity; Body Weight Changes; Health Status; Quality of Life	Other: Nutritional intervention.	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Genetic Predisposition and Body Weight Regulation. Evaluation of Target-genes in Overweight and Obese Adults, Under Different Dietary Interventions.
• Actual Study Start Date: April 13, 2020
• Estimated Primary Completion Date: July 5, 2021
• Estimated Study Completion Date: January 5, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: High-protein hypocaloric diet; Composition of hypocaloric diet: protein:40%,carbohydrates:30% and fat:30%.	Other: Nutritional intervention.; Diets designed for body weight loss, based on different macronutrient content.
Active Comparator: High-carbohydrate hypocaloric diet; Composition of hypocaloric diet: carbohydrate 60%, protein:18% and fat:22%	Other: Nutritional intervention.; Diets designed for body weight loss, based on different macronutrient content.

Outcome Measures

Primary Outcome Measures :

1. Body Weight [ Time Frame: 6 months (i.e. intervention duration) ]
   Changes in body weight compared to baseline.

Secondary Outcome Measures :

1. Body fat percentage [ Time Frame: 6 months (i.e. intervention duration) ]
   Changes in body fat percentage compared to baseline.
2. Waist circumference [ Time Frame: 6 months (i.e. intervention duration) ]
   Changes in waist circumference compared to baseline.
3. Visceral fat [ Time Frame: 6 months (i.e. intervention duration) ]
   Changes in visceral fat compared to baseline.
4. Biochemical profile [ Time Frame: 6 months (i.e. intervention duration) ]
   Changes in biochemical biomarkers related to metabolic syndrome and cardiovascular disease risk (i.e. total cholesterol, glucose, triglyceride and HDL levels) compared to baseline.
5. Sleep quality [ Time Frame: 6 months (i.e. intervention duration) ]
   Changes in sleep quality characteristics compared to baseline. Assessment will take place via use of validated questionnaire.
6. Depression symptoms [ Time Frame: 6 months (i.e. intervention duration) ]
   Changes in any depression symptoms compared to baseline. Assessment will take place via use of validated questionnaire.
7. Overall health status [ Time Frame: 6 months (i.e. intervention duration) ]
   Changes in the overall health status compared to baseline. Assessment will take place via use of validated questionnaire.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.
• 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

Contacts and Locations

Contacts

Contact: Georgios Dedoussis, Prof; +30 2109549179; dedousi@hua.gr

Contact: Andriana Kaliora, Assoc Prof; +30 2109549226; akaliora@hua.gr

Locations

Greece

Harokopio University; Recruiting

Athens, Kallithea, Greece, 17671

Contact: Georgios Dedoussis, Vice Rector +30 2109549179 dedousi@hua.gr

Sponsors and Collaborators

Harokopio University

More Information

Publications:

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. Review.

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• Responsible Party: GEORGIOS DEDOUSSIS, Professor of Molecular Genetics - Nutrigenetics, Vice Rector of Academic of Affairs and Quality Assurance, Harokopio University
• ClinicalTrials.gov Identifier: NCT04699448
• Other Study ID Numbers: 1800/13-06-2019
• First Posted: January 7, 2021
• Last Update Posted: January 7, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GEORGIOS DEDOUSSIS, Harokopio University:

Gene-diet interactions; Nutritional Intervention; Online Self-assessment Tools; Body Composition; Lifestyle characteristics

Additional relevant MeSH terms:

Body Weight; Overweight; Body Weight Changes