Potato Consumption and Energy Balance: a Randomized, Controlled, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in fat mass
研究概览
简要总结
A randomized, clinical trial will be performed to assess changes in body weight and fat mass with daily potato consumption versus a calorie-matched snack of almonds.
详细描述
This is a 30-day randomized, controlled trial with 3 arms: 1) non-potato food (almonds), 2) standard white potato French fry, 3) standard white potato French fry with potential glycemia-modulating spice/seasoning mix added.
Free-living study participants will be assigned to consume one of the 3 foods (calorie matched) each day for a 30-day period. Body composition (via dual energy x-ray absorptiometry; DXA), and blood chemistry will be assayed at baseline and study completion, along with a sub-sample of subjects participating in a meal-based tolerance tests at study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18- 50 years old
- •Body mass index (BMI) 20- 35
- •No dietary restrictions or allergies
- •Weight stable
- •Access to camera through smartphone, computer or tablet
排除标准
- •Pregnancy or anticipating pregnancy or lactation
- •Nut or food allergy
- •Diagnosed diabetes (Type 1 or 2)
- •History of weight control surgery (bariatric or liposuction)
- •Consumes >1 serving of potatoes daily before enrollment
- •Weight loss or gain >5% within past 6 months
- •Medical conditions or medications that would prevent the ability to comply with treatment assignment and/or affect energy balance
- •Dependence on others for food procurement or preparation
结局指标
主要结局
Change in fat mass
时间窗: baseline and study completion (30 days)
Determined by dual-energy X-ray absorptiometry.
次要结局
- Change in fasting insulin(baseline and study completion (30 day))
- Change in fasting glucose(baseline and study completion (30 day))
- Change in body weight(baseline and study completion (30 day))
- Change in HbA1c(baseline and study completion (30 day))
- Change in caloric Intake(baseline and study completion (30 days))
- Meal Tolerance Test(Study Completion (30 day))
研究者
Daniel L. Smith, Jr.
Co-Principal Investigator
University of Alabama at Birmingham