A to Z Study Follow-up: Collection of DNA Data From Buccal Swabs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI.
研究概览
简要总结
The goal of this study is to determine the association between genotypes and diet. The weight and weight loss data are already available from the previously completed study called: A to Z Study - Benefits and Risks of Alternative Weight Loss Strategies - A Clinical Trial, which was performed from 2003-2005 at Stanford University. In the present study, Interleukin Genetics will obtain DNA samples from the previously enrolled study subjects to investigate genetic influence of the response to macronutrient compositions of low caloric diets to weight loss.
详细描述
Interleukin Genetics has derived, through an extensive search of the scientific literature, a genetic test panel in the area of Weight Management (WM), which includes the genes that have been shown to affect body weight. These genes have been associated with elevated risk for obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI (body mass index): 27-40 kg/m2
- •Gender: Women only
- •Age: 25-50
- •Menopausal status: pre-menopausal
- •Weight stable for last 2-months
- •Not on a weight loss plan
- •No ethnic restrictions
- •No plans to move from the area over the next 6-months
- •Willing to accept random assignment
- •Possess English speaking and reading skills to understand and complete forms such as informed consent and study evaluation
排除标准
- •Hypertension
- •Diabetes (type 1 or 2) or history of gestational diabetes
- •Heart disease diagnosis
- •Renal or lever disease
- •Active neoplasms
- •Pregnant, lactating, within 6-months of birth, or planning to become pregnant in the next 6-months
- •Hyperthyroidism, unless treated and under control
- •Medications known to affect weight / energy expenditure
- •Excessive alcohol intake (self-reported, > 3 drinks/day)
- •Postmenopausal, including surgical menopause
- •Currently under psychiatric care, or severely clinically depressed (>17 on Beck Inventory)
结局指标
主要结局
The PRIMARY objective of this study is to identify genotype-diet interaction on weight, body fat, and BMI.
时间窗: 1 year
次要结局
- The SECONDARY objective is to explore the association of single nucleotide polymorphisms (SNPs) with other metabolic parameters, such as blood lipid profile, insulin level, and other cardiovascular risk factors.(1 year)