Overweight and Obesity Clinical Trial
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
Verified date | December 2023 |
Source | Food and Nutrition Research Institute, Philippines |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Philippines | Department of Science and Technology-Food and Nutrition Research Institute | Taguig | Metro Manila |
Lead Sponsor | Collaborator |
---|---|
Food and Nutrition Research Institute, Philippines |
Philippines,
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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