MyGeneMyDiet Trial for Weight Management

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Genetic: MyGeneMyDiet® Recommendations for Weight Management; Other: Usual Standard of Care for Weight Management

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Metro Manila
    • Taguig, Metro Manila, Philippines, 1631
      • Department of Science and Technology-Food and Nutrition Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyGeneMyDiet® Recommendations for Weight Management; A set of nutrition and lifestyle advice for weight management derived from genetic information	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
Active Comparator: Usual Standard of Care for Weight Management; A set of standard nutrition and lifestyle advice for weight management without genetic information	Other: Usual Standard of Care for Weight Management; This group will receive the conventional and standard nutrition lifestyle recommendation for weight management

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Food and Nutrition Research Institute, Philippines
• Investigators: Principal Investigator: Jacus S Nacis, MBAH, Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Nutrigenomics; Nutritional Genomics; DNA-based nutrition advice; Genotype-based nutrition advice
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 19-003-00-00000-2-12-6-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No