iMPROVE: Gene-diet Interactions on Body Weight Regulation and Lifestyle Parameters.
Study Details
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 |
|---|---|---|
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N/A |
Study Design
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
- Body Weight [6 months (i.e. intervention duration)]
Changes in body weight compared to baseline.
Secondary Outcome Measures
- Body fat percentage [6 months (i.e. intervention duration)]
Changes in body fat percentage compared to baseline.
- Waist circumference [6 months (i.e. intervention duration)]
Changes in waist circumference compared to baseline.
- Visceral fat [6 months (i.e. intervention duration)]
Changes in visceral fat compared to baseline.
- Biochemical profile [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.
- Sleep quality [6 months (i.e. intervention duration)]
Changes in sleep quality characteristics compared to baseline. Assessment will take place via use of validated questionnaire.
- Depression symptoms [6 months (i.e. intervention duration)]
Changes in any depression symptoms compared to baseline. Assessment will take place via use of validated questionnaire.
- Overall health status [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
Criteria
Inclusion Criteria:
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Men and women of 18 to 65 years of age.
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Body Mass Index of over 25kg/m2 (presence of overweight or obesity)
Exclusion Criteria:
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Pregnancy or lactation.
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Comorbidities (i.e. type 1 or 2 diabetes, cardiovascular disease, gastrointestinal disorders, mental illness, dietary disorders)
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Dietary supplements aiming at body weight loss
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Parallel participation in a different research study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Harokopio University | Athens | Kallithea | Greece | 17671 |
Sponsors and Collaborators
- Harokopio University
Investigators
None specified.Study Documents (Full-Text)
None provided.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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