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MyGeneMyDiet Trial for Weight Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05098899
Recruitment Status : Active, not recruiting
First Posted : October 28, 2021
Last Update Posted : December 18, 2023
Sponsor:
Information provided by (Responsible Party):
Jacus Nacis, Food and Nutrition Research Institute, Philippines

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Genetic: MyGeneMyDiet® Recommendations for Weight Management Other: Usual Standard of Care for Weight Management Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 5% weight loss [ Time Frame: 24 weeks ]
    Attainment of 5% weight loss

  2. 10% weight loss [ Time Frame: 48 weeks ]
    Attainment of 10% weight loss

  3. Body mass index [ Time Frame: 24 weeks ]
    Changes in BMI

  4. Waist circumference [ Time Frame: 24 weeks ]
    Changes in waist circumference

  5. Body fat percentage [ Time Frame: 24 weeks ]
    Changes in body fat percentage


Secondary Outcome Measures :
  1. Dietary intake [ Time Frame: 24 weeks ]
    Improvements in dietary intake

  2. Eating behavior [ Time Frame: 24 weeks ]
    Improvements in eating behavior

  3. Physical activity level [ Time Frame: 24 weeks ]
    Improvements in physical activity level

  4. Glycated haemoglobin (HbA1c) [ Time Frame: 24 weeks ]
    Changes in HbA1c

  5. Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides) [ Time Frame: 24 weeks ]
    Changes in TC, LDL-C, HDL-C, Triglycerides

  6. Motivation for weight loss [ Time Frame: 24 weeks ]
    Stages and motivation for weight loss

  7. Knowledge and perceptions [ Time Frame: 24 weeks ]
    Knowledge and perceptions in nutrigenomics and genetic testing


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05098899


Locations
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Philippines
Department of Science and Technology-Food and Nutrition Research Institute
Taguig, Metro Manila, Philippines, 1631
Sponsors and Collaborators
Food and Nutrition Research Institute, Philippines
Investigators
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Principal Investigator: Jacus S Nacis, MBAH Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
More Information
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Responsible Party: Jacus Nacis, Senior Science Research Specialist, Food and Nutrition Research Institute, Philippines
ClinicalTrials.gov Identifier: NCT05098899    
Other Study ID Numbers: 19-003-00-00000-2-12-6-2021
First Posted: October 28, 2021    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacus Nacis, Food and Nutrition Research Institute, Philippines:
Overweight
Obesity
Nutritional Genomics
 Nutrigenomics
DNA-based nutrition advice
Genotype-based nutrition advice
Additional relevant MeSH terms:
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Overweight
Overnutrition
Nutrition Disorders
Body Weight