MyGeneMyDiet Trial for Weight Management

NCT ID: NCT05098899

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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MyGeneMyDiet® Recommendations for Weight Management

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

Group Type EXPERIMENTAL

MyGeneMyDiet® Recommendations for Weight Management

Intervention Type 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

Usual Standard of Care for Weight Management

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

Group Type ACTIVE_COMPARATOR

Usual Standard of Care for Weight Management

Intervention Type OTHER

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

Interventions

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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

Intervention Type GENETIC

Usual Standard of Care for Weight Management

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Food and Nutrition Research Institute, Philippines

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jacus Nacis

Senior Science Research Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacus S Nacis, MBAH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Science and Technology-Food and Nutrition Research Institute

City of Taguig, National Capital Region, Philippines

Site Status

Countries

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Philippines

References

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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.

Reference Type BACKGROUND
PMID: 37674889 (View on PubMed)

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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