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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight and Obesity
- Sponsor
- Food and Nutrition Research Institute, Philippines
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Waist circumference
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Jacus Nacis
Senior Science Research Specialist
Food and Nutrition Research Institute, Philippines
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
Outcomes
Primary Outcomes
Waist circumference
Time Frame: 24 weeks
Changes in waist circumference
Body fat percentage
Time Frame: 24 weeks
Changes in body fat percentage
5% weight loss
Time Frame: 24 weeks
Attainment of 5% weight loss
Body mass index
Time Frame: 24 weeks
Changes in BMI
10% weight loss
Time Frame: 48 weeks
Attainment of 10% weight loss
Secondary Outcomes
- Eating behavior(24 weeks)
- Physical activity level(24 weeks)
- Glycated haemoglobin (HbA1c)(24 weeks)
- Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides)(24 weeks)
- Dietary intake(24 weeks)
- Motivation for weight loss(24 weeks)
- Knowledge and perceptions(24 weeks)