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

Primary Purpose

Gene-diet Interactions, Overweight and Obesity, Body Weight Changes

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Nutritional intervention.
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gene-diet Interactions focused on measuring Gene-diet interactions, Nutritional Intervention, Online Self-assessment Tools, Body Composition, Lifestyle characteristics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Harokopio University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High-protein hypocaloric diet

High-carbohydrate hypocaloric diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Body Weight
Changes in body weight compared to baseline.

Secondary Outcome Measures

Body fat percentage
Changes in body fat percentage compared to baseline.
Waist circumference
Changes in waist circumference compared to baseline.
Visceral fat
Changes in visceral fat compared to baseline.
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.
Sleep quality
Changes in sleep quality characteristics compared to baseline. Assessment will take place via use of validated questionnaire.
Overall health status
Changes in the overall health status compared to baseline. Assessment will take place via use of validated questionnaire.

Full Information

First Posted
December 18, 2020
Last Updated
January 9, 2023
Sponsor
Harokopio University
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1. Study Identification

Unique Protocol Identification Number
NCT04699448
Brief Title
Gene-diet Interactions on Body Weight Regulation and Lifestyle Parameters.
Acronym
iMPROVE
Official Title
Genetic Predisposition and Body Weight Regulation. Evaluation of Target-genes in Overweight and Obese Adults, Under Different Dietary Interventions.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
April 14, 2021 (Actual)
Study Completion Date
April 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gene-diet Interactions, Overweight and Obesity, Body Weight Changes, Health Status, Quality of Life
Keywords
Gene-diet interactions, Nutritional Intervention, Online Self-assessment Tools, Body Composition, Lifestyle characteristics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-protein hypocaloric diet
Arm Type
Active Comparator
Arm Description
Composition of hypocaloric diet: protein:40%,carbohydrates:30% and fat:30%.
Arm Title
High-carbohydrate hypocaloric diet
Arm Type
Active Comparator
Arm Description
Composition of hypocaloric diet: carbohydrate 60%, protein:18% and fat:22%
Intervention Type
Other
Intervention Name(s)
Nutritional intervention.
Intervention Description
Diets designed for body weight loss, based on different macronutrient content.
Primary Outcome Measure Information:
Title
Body Weight
Description
Changes in body weight compared to baseline.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body fat percentage
Description
Changes in body fat percentage compared to baseline.
Time Frame
3 months
Title
Waist circumference
Description
Changes in waist circumference compared to baseline.
Time Frame
3 months
Title
Visceral fat
Description
Changes in visceral fat compared to baseline.
Time Frame
3 months
Title
Biochemical profile
Description
Changes in biochemical biomarkers related to metabolic syndrome and cardiovascular disease risk (i.e. total cholesterol, glucose, triglyceride and HDL levels) compared to baseline.
Time Frame
3 months
Title
Sleep quality
Description
Changes in sleep quality characteristics compared to baseline. Assessment will take place via use of validated questionnaire.
Time Frame
3 months
Title
Overall health status
Description
Changes in the overall health status compared to baseline. Assessment will take place via use of validated questionnaire.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Harokopio University
City
Athens
State/Province
Kallithea
ZIP/Postal Code
17671
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31214942
Citation
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.
Results Reference
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PubMed Identifier
25673412
Citation
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Results Reference
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Gene-diet Interactions on Body Weight Regulation and Lifestyle Parameters.

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