MyGeneMyDiet Trial for Weight Management

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05098899
• Other study ID #: 19-003-00-00000-2-12-6-2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: Food and Nutrition Research Institute, Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: August 31, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Genetic:
• MyGeneMyDiet® Recommendations for Weight Management
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

Other:
• Usual Standard of Care for Weight Management
This group will receive the conventional and standard nutrition lifestyle recommendation for weight management

Locations

Country	Name	City	State
Philippines	Department of Science and Technology-Food and Nutrition Research Institute	Taguig	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
Food and Nutrition Research Institute, Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5% weight loss	Attainment of 5% weight loss	24 weeks
Primary	10% weight loss	Attainment of 10% weight loss	48 weeks
Primary	Body mass index	Changes in BMI	24 weeks
Primary	Waist circumference	Changes in waist circumference	24 weeks
Primary	Body fat percentage	Changes in body fat percentage	24 weeks
Secondary	Dietary intake	Improvements in dietary intake	24 weeks
Secondary	Eating behavior	Improvements in eating behavior	24 weeks
Secondary	Physical activity level	Improvements in physical activity level	24 weeks
Secondary	Glycated haemoglobin (HbA1c)	Changes in HbA1c	24 weeks
Secondary	Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides)	Changes in TC, LDL-C, HDL-C, Triglycerides	24 weeks
Secondary	Motivation for weight loss	Stages and motivation for weight loss	24 weeks
Secondary	Knowledge and perceptions	Knowledge and perceptions in nutrigenomics and genetic testing	24 weeks