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临床试验/NCT01908634
NCT01908634已完成不适用

A Pilot Study to Test the Effects of Matrix on Fruit Constituent Bioavailability and Influence on Chronic Disease Risk Factors.

Clinical Nutrition Research Center, Illinois Institute of Technology1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
CMax in Polyphenol Anthocyanin Concentrations

研究概览

简要总结

Primary objective is to evaluate the influence of matrix on the bioavailability of key phytochemical constituents in fruits and their subsequent effect on chronic disease risk factors.

详细描述

This study is a single-center, randomized, cross-over, 4-arm, single- blinded, 6-hour postprandial study to evaluate the effects of strawberry or comparator fruit provided in a formulated beverage with milk (as the base) or water or fresh/pureed.

A planned sample size of 10 men and women will be recruited into the study. Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online and clinic screening mechanisms, including questionnaires, fasting glucose concentration, and anthropometric measurements. Eligible subjects will be invited to participate in the study. Subjects will begin by completing a 3-day pre-study assessment of their usual dietary intake using 3-day food diary. After reviewing baseline food records, subjects will be instructed to avoid polyphenolic-containing foods for 2 days prior to the study visit, while maintaining their usual diet pattern and physical activity.

Subjects will participate in 6 h postprandial study days. Subjects will be randomized on the first day of starting the first post prandial visit day.

For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures published by our lab previously. This includes: pre-study evaluation for compliance (fasting, dinner consumption, limited polyphenol intake) and readiness for study visit, catheter placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate meal accompanied by 1 of the treatment beverages, subsequent blood sampling from catheter [ ~1 tablespoon (12ml)] at designated time points for 6 hours.

Each postprandial study visit day will last approximately 7 hours and subjects will be required to remain at the Clinical Nutrition Research Center at the Illinois Institute of Technology main campus for the duration of the visit. The visit procedures are repeated four times ~ 1 week apart to accommodate subject testing with all four beverages; all procedures are identical on each postprandial study test visit with the exception that only an assigned test beverage per each visit will be consumed with the breakfast.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult (18-78 years of age)
  • •Relatively healthy
  • •Non-smoker or past smoker with abstinence for at least 2 years

排除标准

  • •Pregnant and/or breast feeding
  • •Smoker or past smoker with abstinence <2 years
  • •Allergy or intolerance to study foods
  • •Current regular consumption of berries is > 2 servings per day.
  • •Fasting blood glucose ≥ 126 mg/dL. Subjects identified with elevated fasting blood glucose levels will be advised to contact their primary care physician for appropriate follow-up care.
  • •Taking over the counter antioxidant supplements or other supplements that may interfere with the study procedures or endpoints.
  • •Subjects with unusual dietary habits (e.g. pica).
  • •Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 lbs in a 60 day period).
  • •Excessive exercisers or trained athletes.
  • •Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, or other systemic diseases.
  • •Addicted to drugs and/or alcohol.
  • •Medically documented psychiatric or neurological disturbances.
  • •Severe obesity as defined by >39.9 BMI or under weight for height (BMI <18.5)

研究组 & 干预措施

Milk-based Strawberry Beverage no meal

Active Comparator

Milk-based Strawberry beverage without meal

干预措施: Milk-based Strawberry Beverage without meal (Dietary Supplement)

Water-based Strawberry Beverage no meal

Experimental

Water-based Strawberry beverage without meal

干预措施: Water-Based Strawberry Beverage without meal (Dietary Supplement)

Milk-based strawberry Beverage with meal

Active Comparator

Milk-based Strawberry beverage with meal

干预措施: Milk-based strawberry Beverage with meal (Dietary Supplement)

Water-based strawberry Beverage with meal

Experimental

Water-based Strawberry beverage with meal

干预措施: Water-Based strawberry Beverage with meal (Dietary Supplement)

结局指标

主要结局

CMax in Polyphenol Anthocyanin Concentrations

时间窗: 6 hours

Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect Cmax

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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Matrix on Fruit Constituent Bioavailability | 临床试验