MyGeneMyDiet Trial for Weight Management

Study Overview
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Brief Summary
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The study aims to determine if genotype-based nutrition and lifestyle advice is effective for the management of overweight and obesity among Filipino adults compared to the usual standard of care.

Detailed Description
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The primary objective of the study is to determine if providing a nutrition and lifestyle advice with genetic information can promote the attainment of 5-10% weight loss, and improvements on body mass index, waist circumference, and body fat percentage among Filipino adults with overweight and obesity. Additionally, changes in dietary intake, eating behaviour, physical activity level, biochemical parameters (HbA1c and blood lipid profile), motivation for weight loss, and knowledge and perceptions on nutrigenomics and genetic testing will also be assessed.

Official Title
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Interventions Using Genomics-based Strategies (InGeSt) Towards Enhanced Nutrition Recommendations: A Proof-of-concept RCT for the DNA-based Nutrition and Lifestyle Recommendations in Overweight and Obese Filipino Adults

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Genetic: MyGeneMyDiet® Recommendations for Weight Management
* Other: Usual Standard of Care for Weight Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight or obese Filipino adults who signify a willingness to participate in the study With BMI equal to 25.0 but not more than 40 kg/m2 Apparently healthy (fasting blood glucose, lipid profile, and blood pressure within the normal range to pre-disease state) Normal thyroid hormone levels in the blood Normal blood cortisol level Carriers of at least one of the risk alleles of FTO rs9939609, UCP1 rs1800592, and TCF7L2 rs7903146 Exclusion Criteria: Elevated levels of fasting blood glucose, blood lipids, and blood pressure Elevated levels of thyroid hormones, and cortisol level Self-reported/history of heart disease Participation in a weight loss program or adherence to restrictive /therapeutic diet in the past 3 month Self-reported of recent weight changes greater or less than 3.0 kg Planned or recent bariatric surgery Consumption of weight-altering medications and/or nutritional supplements that promote weight gain/loss in the past 6 months Clinical diagnosis of any mental disorder and current use of any mental health medications Pregnant, nursing, or with self-declared intention to become pregnant Any health condition that may put the participant at risk Current and anticipated enrolment in another research study during the course of the trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyGeneMyDiet® Recommendations for Weight Management<br>A set of nutrition and lifestyle advice for weight management derived from genetic information | Genetic: MyGeneMyDiet® Recommendations for Weight Management<br>* This group will receive Nutrition and Lifestyle recommendation based on SNPs known to have an impact to body weight and body composition, and responses to physical activity and dietary fat intake<br>|
| Active Comparator: Usual Standard of Care for Weight Management<br>A set of standard nutrition and lifestyle advice for weight management without genetic information | Other: Usual Standard of Care for Weight Management<br>* This group will receive the conventional and standard nutrition lifestyle recommendation for weight management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5% weight loss | Attainment of 5% weight loss | 24 weeks | 
| 10% weight loss | Attainment of 10% weight loss | 48 weeks | 
| Body mass index | Changes in BMI | 24 weeks | 
| Waist circumference | Changes in waist circumference | 24 weeks | 
| Body fat percentage | Changes in body fat percentage | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake | Improvements in dietary intake | 24 weeks | 
| Eating behavior | Improvements in eating behavior | 24 weeks | 
| Physical activity level | Improvements in physical activity level | 24 weeks | 
| Glycated haemoglobin (HbA1c) | Changes in HbA1c | 24 weeks | 
| Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides) | Changes in TC, LDL-C, HDL-C, Triglycerides | 24 weeks | 
| Motivation for weight loss | Stages and motivation for weight loss | 24 weeks | 
| Knowledge and perceptions | Knowledge and perceptions in nutrigenomics and genetic testing | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, Nutritional Genomics, Nutrigenomics, DNA-based nutrition advice, Genotype-based nutrition advice