Berry Components and Blood Sugar & Fat Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Glucose Metabolism Phase 1
研究概览
简要总结
The primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans.
详细描述
The aim of this study is to improve understanding of how diet can regulate glucose metabolism and fuel use. Previous human and animal studies have demonstrated that berries can improve gluco-regulation and increase fat oxidation. The aim of this study is to determine which component of berries is conveying this health benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoker
- •able to understand consent
排除标准
- •Body Mass Index less than 25 kg/m2
- •pregnant, lactating, having given birth in the past year
- •allergy to berries
- •blood glucose greater than 125 mg/dL
- •history of bariatric surgery or nutrient malabsorption disease
- •diagnosis or treatment of cancer in past three years
- •type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
研究组 & 干预措施
Mixed Berry Diet
Participants will receive between 400 to 800 grams of mixed berries daily, as a proportion of their daily caloric intake added to their base diet. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
干预措施: Mixed Berry Diet (Other)
Carbohydrate Control Jello
Participants will receive between 400 to 800 grams of strawberry jello daily, as a proportion of their daily caloric intake added to their base diet. The jello will be matched to the mixed berries in both total carbohydrate level and gram quantity. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
干预措施: Carbohydrate Control Jello (Other)
Fiber Enriched Jello
Participants will receive between 400 to 800 grams of fiber enriched strawberry jello daily, as a proportion of their daily caloric intake added to their base diet. The jello will be matched to the mixed berries in both total carbohydrate level and fiber content, and in the same gram quantity. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
干预措施: Fiber Enriched Jello (Other)
Low Fiber Mixed Berry Juice
Participants will receive 1 liter per day of low fiber mixed berry juice added to their base diet. The juice will be squeezed from the mixed berries, then filtered. The sugar level of the juice will match that of the mixed berries. The base diet will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
干预措施: Low Fiber Mixed Berry Juice (Other)
结局指标
主要结局
Glucose Metabolism Phase 1
时间窗: Day 8
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Glucose Metabolism Phase 2
时间窗: Day 29
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Glucose Metabolism Phase 3
时间窗: Day 50
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
Glucose Metabolism Phase 4
时间窗: Day 71
Subjects will undergo a meal-based glucose tolerance test; blood samples will be analyzed for glucose in mmol/L.
次要结局
- Insulin sensitivity(Day 8, 29, 50, 71)
- Fat trafficking(Day 8, 29, 50, 71)
- Peripheral mononuclear blood cells energetics(Day 8, 29, 50, 71)
- Metabolic Fuel Use(Day 7-8, 28-29, 49-50, 70-71)
研究者
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center