MyGeneMyDiet Trial for Weight Management

Food and Nutrition Research Institute, Philippines

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: Usual Standard of Care for Weight Management; Genetic: MyGeneMyDiet® Recommendations for Weight Management

Study type: Interventional

Funder types: Other

Identifiers

NCT05098899

19-003-00-00000-2-12-6-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 19 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

MyGeneMyDiet® Recommendations for Weight Management

Experimental group

Description:

A set of nutrition and lifestyle advice for weight management derived from genetic information

Treatment:

Genetic: MyGeneMyDiet® Recommendations for Weight Management

Usual Standard of Care for Weight Management

Active Comparator group

Description:

A set of standard nutrition and lifestyle advice for weight management without genetic information

Treatment:

Other: Usual Standard of Care for Weight Management