Clinical trial NCT04699448: Gene-diet Interactions on Body Weight Regulation and Lifestyle Parameters.
Official title: Genetic Predisposition and Body Weight Regulation. Evaluation of Target-genes in Overweight and Obese Adults, Under Different Dietary Interventions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Body Weight
timeFrame: 3 months
Secondary outcomes:
measure: Body fat percentage
timeFrame: 3 months
measure: Waist circumference
timeFrame: 3 months
measure: Visceral fat
timeFrame: 3 months
measure: Biochemical profile
timeFrame: 3 months
measure: Sleep quality
timeFrame: 3 months
measure: Overall health status
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University
state: Kallithea
Study officials:
References:
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