Gene-Environment Interaction and Precision Nutrition on Adiposity, Glycemic, Lipids Changes, and Bone Health
Obesity Genes, Energy Regulation in Response to Weight-Loss
The purpose of this study is to test the interactions between the genes and diet interventions varying in macronutrient intake on glycemic, waist circumference, body weight, visceral fat and lipids changes. In the POUNDS LOST, all of the 811 participants DNA was extracted from the buffy coat fraction of centrifuged blood using the QIAmp blood kit (Qiagen, Chatsworth, CA). Single nucleotide polymorphisms were genotyped using the OpenArray™ SNP genotyping system (BioTrove, Woburn, MA). The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative.
Besides, the investigators integrated novel pathway analyses in large cohorts and comprehensive genetic analyses on long-term weight loss and mechanisms in randomized diet intervention trials would provide very important evidence to unravel the etiology of obesity, and have significant public health and clinical implications. Establishing relationship between genetic variants and diets in determining weight change will help identify individuals at high risk for obesity especially when adherent to specific diet.
研究概览
详细说明
The epidemic of obesity has become a major public health problem. Obesity is a multifactorial abnormality that has a genetic basis but requires environmental influences to manifest. Common-form obesity is underpinned by both environmental and genetic factors. Recent genome-wide association studies have identified several genes convincingly related to obesity risk. Testing gene-environment interaction is a relatively new field. Evidence from association studies and intervention trials continues to mount, indicating that genetic components may modify lifestyle effects on the development of obesity. However, these findings are at most preliminary. The interplay between genetic and environmental components may facilitate the choice of more effective and specific measures for obesity prevention based on personalized genetic make-up.
The investigators aimed to examine whether the genetic variation affected glycemic, waist circumference, body weight, visceral fat and lipids changes in response to weight-loss dietary intervention varying in macronutrient intake (target percentages of energy derived from fat, protein, and carbohydrate in the 4 diets were as follows 20%, 15% and 65%; 20%, 25%, and 55%; 40%, 15%, and 45%; and 40%, 25%, and 35%).
The primary outcome is to test the interactions between the genes and diet interventions varying in macronutrient intake on body weight changes. The secondary outcome is to test the interactions between the genes and diet interventions varying in macronutrient intake on glycemic, waist circumference, visceral fat, and lipids changes. Understanding gene-diet interactions in relation to weight loss hold great promise for delivering more efficient prevention and treatment on obesity and related metabolic disorders.
In addition, besides gene-diet interactions, the investigators will also conduct other precision nutrition analysis. These analyses include interactions between pretreatment factors with diet intervention adiposity traits, initial changes induced by diet intervention with various outcomes measured in POUNDS Lost, including body weight, waist circumference, body composition, ectopic fat, and bone health.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area
- Between the ages of 30 - 70
- Willing to modify eating pattern according to instructions
- Overweight or obese and in good health with a BMI of 25-40
- Committed to a long-term weight loss and maintenance program
- Willing to attend multiple weight loss group sessions
- Willing to increase activity level
Exclusion Criteria:
- Pregnant, planning to become pregnant, or are breastfeeding
- Unwilling to participate in the schedule of group sessions and individual visits
- Unstable or recent onset of heart disease or any other serious illness
- Cannot change diet due to medical or other reasons
- Planning to leave the area prior to the anticipated end of participation
- Current participation in another clinical trial with an intervention that affects weight change
- Have diabetes that is treated with insulin or hypoglycemic oral medicines
- Diagnosis of psychiatric or emotional problems within 6 months of study
- Currently have an eating disorder
- Have hypothyroidism
- Have an unstable weight
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：diet 1
diet with moderate in fat (40% energy) and protein(15%)
|
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
|
|
实验性的：diet 2
diet with moderate in fat (40% energy) and protein(25%)
|
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
|
|
实验性的：diet 3
diet with low in fat (20% energy) and protein(15%)
|
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
|
|
实验性的：diet 4
diet with low in fat (20% energy) and protein(25%)
|
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Test the interactions between the genes and diet interventions varying in macronutrient intake on body weight changes(weight in kilograms) .
大体时间：measured at Year 2
|
measured at Year 2
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Test the interactions between the genes and diet interventions varying in macronutrient intake on glycemic changes (mg/dL for fasting glucose,uU/mL for fasting insulin).
大体时间：measured at Year 2
|
measured at Year 2
|
|
|
Test the interactions between the genes and diet interventions varying in macronutrient intake on waist circumference changes (cm).
大体时间：measured at Year 2
|
measured at Year 2
|
|
|
Test the interactions between the genes and diet interventions varying in macronutrient intake on visceral fat changes (%).
大体时间：measured at Year 2
|
measured at Year 2
|
|
|
Test the interactions between the genes and diet interventions varying in macronutrient intake on lipids changes (mg/dL for Total cholesterol, HDL cholesterol, LDL cholesterol and Triglycerides).
大体时间：measured at Year 2
|
measured at Year 2
|
|
|
Test the interactions between the genes and diet interventions varying in macronutrient intake on bone health (Bone mineral density at different skeletal sites).
大体时间：measured at Year 2
|
Bone mineral density was measured by dual-energy X-ray (DEXA)
|
measured at Year 2
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ectopic fat
大体时间：2 year (measured at baseline, 6 months, and 2 years)
|
Computed tomography (CT) measured hepatic fat, abdominal fat distribution (includes visercal adipose tissue, subcutaneous adipose tissue, and total adipose tissue)
|
2 year (measured at baseline, 6 months, and 2 years)
|
合作者和调查者
出版物和有用的链接
一般刊物
- Zhou T, Sun D, Heianza Y, Li X, Champagne CM, LeBoff MS, Shang X, Pei X, Bray GA, Sacks FM, Qi L. Genetically determined vitamin D levels and change in bone density during a weight-loss diet intervention: the Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) Trial. Am J Clin Nutr. 2018 Nov 1;108(5):1129-1134. doi: 10.1093/ajcn/nqy197.
- Han L, Ma W, Sun D, Heianza Y, Wang T, Zheng Y, Huang T, Duan D, Bray JGA, Champagne CM, Sacks FM, Qi L. Genetic variation of habitual coffee consumption and glycemic changes in response to weight-loss diet intervention: the Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial. Am J Clin Nutr. 2017 Nov;106(5):1321-1326. doi: 10.3945/ajcn.117.156232. Epub 2017 Sep 20.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.