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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05098899
Other study ID # 19-003-00-00000-2-12-6-2021
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date August 31, 2024

Study information

Verified date December 2023
Source Food and Nutrition Research Institute, Philippines
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 62
Est. completion date August 31, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 59 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Other:
Usual Standard of Care for Weight Management
This group will receive the conventional and standard nutrition lifestyle recommendation for weight management

Locations

Country Name City State
Philippines Department of Science and Technology-Food and Nutrition Research Institute Taguig Metro Manila

Sponsors (1)

Lead Sponsor Collaborator
Food and Nutrition Research Institute, Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5% weight loss Attainment of 5% weight loss 24 weeks
Primary 10% weight loss Attainment of 10% weight loss 48 weeks
Primary Body mass index Changes in BMI 24 weeks
Primary Waist circumference Changes in waist circumference 24 weeks
Primary Body fat percentage Changes in body fat percentage 24 weeks
Secondary Dietary intake Improvements in dietary intake 24 weeks
Secondary Eating behavior Improvements in eating behavior 24 weeks
Secondary Physical activity level Improvements in physical activity level 24 weeks
Secondary Glycated haemoglobin (HbA1c) Changes in HbA1c 24 weeks
Secondary Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides) Changes in TC, LDL-C, HDL-C, Triglycerides 24 weeks
Secondary Motivation for weight loss Stages and motivation for weight loss 24 weeks
Secondary Knowledge and perceptions Knowledge and perceptions in nutrigenomics and genetic testing 24 weeks
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