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临床试验/NCT04699448
NCT04699448已完成不适用

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

Harokopio University2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2020年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
2
主要终点
Body Weight

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women of 18 to 65 years of age.
  • Body Mass Index of over 25kg/m2 (presence of overweight or obesity)

排除标准

  • 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

结局指标

主要结局

Body Weight

时间窗: 3 months

Changes in body weight compared to baseline.

次要结局

  • Waist circumference(3 months)
  • Biochemical profile(3 months)
  • Body fat percentage(3 months)
  • Visceral fat(3 months)
  • Sleep quality(3 months)
  • Overall health status(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GEORGIOS DEDOUSSIS

Professor of Molecular Genetics - Nutrigenetics, Vice Rector of Academic of Affairs and Quality Assurance

Harokopio University

研究点 (2)

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