MyGeneMyDiet Trial for Weight Management

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity
• Interventions: Genetic: MyGeneMyDiet® Recommendations for Weight Management; Other: Usual Standard of Care for Weight Management

• Registration Number: NCT05098899
• Lead Sponsor: Food and Nutrition Research Institute, Philippines

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-28
• Study Start: 2021-12-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-05-30
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyGeneMyDiet® Recommendations for Weight Management	MyGeneMyDiet® Recommendations for Weight Management	A set of nutrition and lifestyle advice for weight management derived from genetic information
Usual Standard of Care for Weight Management	Usual Standard of Care for Weight Management	A set of standard nutrition and lifestyle advice for weight management without genetic information

Primary Outcome Measures

Name	Time	Method
Waist circumference	24 weeks	Changes in waist circumference
Body fat percentage	24 weeks	Changes in body fat percentage
5% weight loss	24 weeks	Attainment of 5% weight loss
Body mass index	24 weeks	Changes in BMI
10% weight loss	48 weeks	Attainment of 10% weight loss

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Science and Technology-Food and Nutrition Research Institute; 🇵🇭 Taguig, Metro Manila, Philippines