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Completed

NCT Number: NCT04699448

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harokopio University

Athens, Kallithea, 17671, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional intervention.

Other

Diets designed for body weight loss, based on different macronutrient content.

Primary outcomes

  1. Body Weight

    Time frame: 3 months

    Changes in body weight compared to baseline.

Secondary outcomes

  1. Body fat percentage

    Time frame: 3 months

    Changes in body fat percentage compared to baseline.

  2. Waist circumference

    Time frame: 3 months

    Changes in waist circumference compared to baseline.

  3. Visceral fat

    Time frame: 3 months

    Changes in visceral fat compared to baseline.

  4. Biochemical profile

    Time frame: 3 months

    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: 3 months

    Changes in sleep quality characteristics compared to baseline. Assessment will take place via use of validated questionnaire.

  6. Overall health status

    Time frame: 3 months

    Changes in the overall health status compared to baseline. Assessment will take place via use of validated questionnaire.

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Registry information

Official study title

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

Acronym: iMPROVE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2021
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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