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临床试验/NCT01403857
NCT01403857已完成不适用

Evaluating Liking, Acceptability and Health Benefits of Grain Products

USDA, Western Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Change in the acceptability and liking of grain products

研究概览

简要总结

The specific aims of the Grain Study are to determine if exposure to different types of grain products, over a period of 6 weeks, changes liking and acceptability and to determine if the gut microbiota, bacterial fermentation products, or gastrointestinal function changes with consumption of whole grains or refined grains.

详细描述

Subjects will be recruited in accordance with inclusion and exclusion criteria listed below. Subjects will be assigned to one of two different grain product 'exposure' groups - Group 1 will receive predominantly Whole Grain (WG) products and Group 2 will receive predominantly Refined Grain (RG) products (ratio of WG to RG assignment will be 2:1). For a 6-week exposure period, subjects will receive weekly market baskets of grain products consisting of breakfast cereals, breads, snack items, and side dishes with the target of providing whole grains at a level of 85% of grain intake for the WG group (this exceeds the current Dietary Guideline recommendation of 50%) and 15% for the RG group (this is the current estimated intake for U.S. adults). Before and after grain exposure, subjects will rate the acceptability and liking of numerous grain products. To accomplish this, subjects will participate in sensory evaluation tests using these products, and they will provide information using validated questionnaires and take implicit association tests. During the 6-week study period, subjects will record use of the market basket grain products, and provide subjective scores for taste, convenience, nutrition, and general liking. The quality of the total dietary intake will be assessed using unannounced 24-h recalls. Biological samples will also be collected from subjects. Blood and urine samples will be collected to evaluate risk factors of chronic disease, and biomarkers of whole grain intake, fruits and vegetables. Saliva and fecal samples will be collected to measure changes in gut microbiota and to measure metabolites of bacterial fermentation. Breath hydrogen tests will be conducted to measure bacterial fermentation. Two weeks after the end of the intervention period, subjects will participate in a nominal group session to identify significant barriers and facilitators to inclusion of grain products into their diets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 20-45 years of age
  • male or female
  • consumers of 1 or fewer whole grain products per day

排除标准

  • Type I or II Diabetes or glucose intolerance
  • Preference for whole grains
  • Do not cook at home
  • Pregnant or planning to be pregnant
  • Chronic inflammatory bowel disease
  • colorectal cancer
  • Celiac disease or gluten sensitivity
  • Crohn's disease
  • Regular use of colonics and/or laxatives
  • body weight change of >3% in last 6 months
  • use of antibiotics, appetite suppressants, mood altering medications, and regular tobacco use.

结局指标

主要结局

Change in the acceptability and liking of grain products

时间窗: 0, 6 weeks

Sensory evaluation of grain products

Change in the gut microbiota and their fermentation products

时间窗: 0, 6 weeks

To determine if gut microbiota change over the intervention and if those changes persist over the long term. Gut microbiota assessed using 16S methodology.

次要结局

  • Change in gastrointestinal function(0, 6 weeks)
  • Liking the taste of grain products(0, 6 weeks)

研究者

发起方
USDA, Western Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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