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临床试验/NCT03082131
NCT03082131已完成不适用

Resistant Starch Wheat for Improved Metabolic Health: A Proof of Concept Study in Human Subjects

USDA, Western Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年5月22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
发起方
入组人数
36
试验地点
2
主要终点
Changes in Gut Microbiota Composition

研究概览

简要总结

The objective of this study is to determine the effect of wheat enriched in resistant starch (RS) on the generation of fermentation products by the lower gut microbes, the fecal microbiota profile, intestinal metabolites, and the glycemic response to a test meal compared to regular wheat.

详细描述

Resistant starch (RS) is a type of dietary fiber that provides fermentable carbohydrate (FC) in the lower bowel yielding positive effects on postprandial glycemia and weight management as well as digestive tract health. RS is defined as the portion of starch resistant to digestion by amylases, allowing it to reach the distal intestine where it can be fermented by the resident intestinal microbiota. A limited number of human studies using RS from high amylose corn have demonstrated that RS increases synthesis of gut peptides that improve glucose homeostasis and insulin secretion. Based on these studies, the FDA has recently approved the following health claims for resistant starch derived from corn (RS2): lowering of blood glucose, blood cholesterol, and blood pressure; increased mineral absorption; improved laxation; and reduced energy intake. The purpose in the proposed "proof of concept" study here is to show that RS provided in the form of wheat flour products has similar beneficial effects. The investigators aim to further explore the effect of RS on the gut microbiota. The intestinal microbiome is comprised of over one trillion bacterial cells comprised of approximately one thousand species that perform diverse functions ranging from energy harvest, angiogenesis, immunomodulation, and regulation of mood and behavior. Some of the major products of bacterial metabolism include acetate, propionate, and butyrate, the major short chain fatty acids (SCFA). These bioactive fermentation products have been associated with improved glucose homeostasis, attributed, in part, by their interactions with receptors on intestinal cells to augment secretion of glucagon-like peptide-1 (GLP-1), an incretin hormone known to stimulate insulin secretion.

This study is a randomized, cross-over design consisting of two 1-week dietary intervention periods as well as a 2-week washout period in between. Subjects will be randomly assigned to receive either RS wheat first or regular wheat first, then will be crossed over to the opposite treatment following a 2-week washout period. Wheat products made from RS wheat and regular wheat will be provided and the volunteers will be instructed to incorporate the products into their usual diet for 7 days. This study will probe the associations between the gut microbiota profiles, fermentation of RS wheat, microbial-mediated alterations in bile acids, and glycemia. The investigators will measure these effects in healthy, middle-aged humans using an interdisciplinary approach that integrates nutrition, microbiology, intestinal physiology, and analytical chemistry.

研究设计

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

盲法说明

Participants and investigators will be blinded to the type of product (i.e. RS wheat or Regular Wheat) the subjects are consuming during each arm of the study.

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults. Healthy means that the candidate reports that s/he feels well and can perform normal activities.

排除标准

  • BMI <18.5 and >39.9 kg/m2
  • Presence of of untreated or uncontrolled metabolic diseases
  • Presence of gastrointestinal disorders that could interfere with the study outcome (i.e. Crohn's disease, Irritable bowel syndrome, Colitis)
  • Use of oral antibiotics within the past 3 months
  • Presence of cancer or other serious chronic disease by self report
  • Current use of prescribed or over the counter weight loss medications
  • Lactating
  • Current use of tobacco
  • Dietary restrictions that would interfere with consuming the intervention foods

研究组 & 干预措施

Group 1

Experimental

Order of treatments:

A. Resistant Starch Wheat B. Regular Wheat

干预措施: Resistant Starch Wheat (Dietary Supplement)

Group 2

Experimental

Order of treatments:

A. Regular Wheat B. Resistant Starch Wheat

干预措施: Resistant Starch Wheat (Dietary Supplement)

结局指标

主要结局

Changes in Gut Microbiota Composition

时间窗: Days 1, 7, 22, and 29

Gut microbiota community composition will be determined by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from stool samples

次要结局

  • Changes in Gut Microbiota Metabolism(0, 1, 2, and 3 hours postprandial)
  • Evaluation of Consumer Acceptance(Days 8 and 30)
  • Dietary Intake(Days 3, 5, 8, 25, 27, and 30)
  • Changes in Glucose Metabolism(0, 1, 2, and 3 hours postprandial)

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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