MyGeneMyDiet Trial for Weight Management

NCT05098899 | Completed DMC

• 1 other identifier: 19-003-00-00000-2-12-6-2021
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Overweight; Obesity; Nutritional Genomics; Nutrigenomics; DNA-based nutrition advice; Genotype-based nutrition advice

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Dietary intake

  24 weeks

• Eating behavior

  24 weeks

• Physical activity level

  24 weeks

• Glycated haemoglobin (HbA1c)

  24 weeks

• Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides)

  24 weeks

Study Arms (2)

MyGeneMyDiet® Recommendations for Weight Management

EXPERIMENTAL

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

Genetic: MyGeneMyDiet® Recommendations for Weight Management

Usual Standard of Care for Weight Management

ACTIVE COMPARATOR

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

Other: Usual Standard of Care for Weight Management

Interventions

MyGeneMyDiet® Recommendations for Weight Management GENETIC

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

MyGeneMyDiet® Recommendations for Weight Management

Usual Standard of Care for Weight Management OTHER

This group will receive the conventional and standard nutrition lifestyle recommendation for weight management

Usual Standard of Care for Weight Management

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Food and Nutrition Research Institute, Philippines: lead

Study Sites (1)

Department of Science and Technology-Food and Nutrition Research Institute

City of Taguig, National Capital Region, 1631, Philippines

Location

Related Publications (1)

• Nacis JS, Labrador JPH, Ronquillo DGD, Rodriguez MP, Dablo AMFD, Frane RD, Madrid ML, Santos NLC, Carrillo JJV, Fernandez MG, Gonzales GBL. A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(R) study. Front Nutr. 2023 Aug 22;10:1238234. doi: 10.3389/fnut.2023.1238234. eCollection 2023.

  PMID: 37674889 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacus S Nacis, MBAH

  Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Science Research Specialist

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 28, 2021
• Study Start: December 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: August 31, 2024
• Last Updated: March 12, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)