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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Waist circumference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Waist circumference
时间窗: 24 weeks
Changes in waist circumference
Body fat percentage
时间窗: 24 weeks
Changes in body fat percentage
5% weight loss
时间窗: 24 weeks
Attainment of 5% weight loss
Body mass index
时间窗: 24 weeks
Changes in BMI
10% weight loss
时间窗: 48 weeks
Attainment of 10% weight loss
次要结局
- 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)
研究者
Jacus Nacis
Senior Science Research Specialist
Food and Nutrition Research Institute, Philippines