Clinical trial NCT05098899: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Nutritional Genomics
Nutrigenomics
DNA-based nutrition advice
Genotype-based nutrition advice
Lead sponsor: Food and Nutrition Research Institute, Philippines
Sponsor class: OTHER_GOV
First posted: 2021-10-28
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 5% weight loss
timeFrame: 24 weeks
measure: 10% weight loss
timeFrame: 48 weeks
measure: Body mass index
timeFrame: 24 weeks
measure: Waist circumference
timeFrame: 24 weeks
measure: Body fat percentage
timeFrame: 24 weeks
Secondary outcomes:
measure: Dietary intake
timeFrame: 24 weeks
measure: Eating behavior
timeFrame: 24 weeks
measure: Physical activity level
timeFrame: 24 weeks
measure: Glycated haemoglobin (HbA1c)
timeFrame: 24 weeks
measure: Blood lipid profile (TC, LDL-C, HDL-C, Triglycerides)
timeFrame: 24 weeks
measure: Motivation for weight loss
timeFrame: 24 weeks
measure: Knowledge and perceptions
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Taguig
country: Philippines
facility: Department of Science and Technology-Food and Nutrition Research Institute
state: Metro Manila
Study officials:
affiliation: Department of Science and Technology-Food and Nutrition Research Institute (DOST-FNRI)
name: Jacus S Nacis, MBAH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nacis JS, Labrador JPH, Ronquillo DGD, Rodriguez MP, Dablo AMFD, Frane RD, Madrid ML, Santos NLC, Carrillo JJV, Fernandez MG, Gonzales GBL. A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet(R) study. Front Nutr. 2023 Aug 22;10:1238234. doi: 10.3389/fnut.2023.1238234. eCollection 2023.