Back to resultsMyGeneMyDiet Trial for Weight Management
Primary Purpose
Overweight and Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
MyGeneMyDiet® Recommendations for Weight Management
Usual Standard of Care for Weight Management
Sponsored by
About this trial
This is an interventional prevention trial for Overweight and Obesity focused on measuring Overweight, Obesity, Nutritional Genomics, Nutrigenomics, DNA-based nutrition advice, Genotype-based nutrition advice
Eligibility 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
Sites / Locations
- Department of Science and Technology-Food and Nutrition Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MyGeneMyDiet® Recommendations for Weight Management
Usual Standard of Care for Weight Management
Arm Description
A set of nutrition and lifestyle advice for weight management derived from genetic information
A set of standard nutrition and lifestyle advice for weight management without genetic information
Outcomes
Primary Outcome Measures
5% weight loss
Attainment of 5% weight loss
10% weight loss
Attainment of 10% weight loss
Body mass index
Changes in BMI
Waist circumference
Changes in waist circumference
Body fat percentage
Changes in body fat percentage
Secondary Outcome Measures
Dietary intake
Improvements in dietary intake
Eating behavior
Improvements in eating behavior
Physical activity level
Improvements in physical activity level
Glycated haemoglobin (HbA1c)
Changes in HbA1c
Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides)
Changes in TC, LDL-C, HDL-C, Triglycerides
Motivation for weight loss
Stages and motivation for weight loss
Knowledge and perceptions
Knowledge and perceptions in nutrigenomics and genetic testing
Full Information
NCT ID
NCT05098899
First Posted
October 20, 2021
Last Updated
February 14, 2023
Sponsor
Food and Nutrition Research Institute, Philippines
1. Study Identification
Unique Protocol Identification Number
NCT05098899
Brief Title
MyGeneMyDiet Trial for Weight Management
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Food and Nutrition Research Institute, Philippines
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Overweight, Obesity, Nutritional Genomics, Nutrigenomics, DNA-based nutrition advice, Genotype-based nutrition advice
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MyGeneMyDiet® Recommendations for Weight Management
Arm Type
Experimental
Arm Description
A set of nutrition and lifestyle advice for weight management derived from genetic information
Arm Title
Usual Standard of Care for Weight Management
Arm Type
Active Comparator
Arm Description
A set of standard nutrition and lifestyle advice for weight management without genetic information
Intervention Type
Genetic
Intervention Name(s)
MyGeneMyDiet® Recommendations for Weight Management
Intervention Description
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
Other
Intervention Name(s)
Usual Standard of Care for Weight Management
Intervention Description
This group will receive the conventional and standard nutrition lifestyle recommendation for weight management
Primary Outcome Measure Information:
Title
5% weight loss
Description
Attainment of 5% weight loss
Time Frame
24 weeks
Title
10% weight loss
Description
Attainment of 10% weight loss
Time Frame
48 weeks
Title
Body mass index
Description
Changes in BMI
Time Frame
24 weeks
Title
Waist circumference
Description
Changes in waist circumference
Time Frame
24 weeks
Title
Body fat percentage
Description
Changes in body fat percentage
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Dietary intake
Description
Improvements in dietary intake
Time Frame
24 weeks
Title
Eating behavior
Description
Improvements in eating behavior
Time Frame
24 weeks
Title
Physical activity level
Description
Improvements in physical activity level
Time Frame
24 weeks
Title
Glycated haemoglobin (HbA1c)
Description
Changes in HbA1c
Time Frame
24 weeks
Title
Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides)
Description
Changes in TC, LDL-C, HDL-C, Triglycerides
Time Frame
24 weeks
Title
Motivation for weight loss
Description
Stages and motivation for weight loss
Time Frame
24 weeks
Title
Knowledge and perceptions
Description
Knowledge and perceptions in nutrigenomics and genetic testing
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacus S Nacis, MBAH
Phone
+632 8837-8113-14
Ext
329
Email
jacusnacis@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Glades D Ronquillo, BSc
Phone
+632 8837-8113-14
Ext
329
Email
dianaglades@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacus S Nacis, MBAH
Organizational Affiliation
Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Science and Technology-Food and Nutrition Research Institute
City
Taguig
State/Province
Metro Manila
ZIP/Postal Code
1631
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacus S Nacis, MBAH
Phone
+632 8837-8113-14
Ext
329
Email
jacusnacis@gmail.com
First Name & Middle Initial & Last Name & Degree
Jason Paolo H Labrador, BSc
12. IPD Sharing Statement
Plan to Share IPD
No
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