An interventional study of Resistant Starch Wheat in Gut Microbiota, Metabolism and Metabolic Health, sponsored by USDA, Western Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by USDA, Western Human Nutrition Research Center · Not applicable, Interventional, and Basic science
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.
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.
USDA, Western Human Nutrition Research Center is the lead sponsor of 53 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Order of treatments: A. Resistant Starch Wheat B. Regular Wheat
Dietary Supplement: Resistant Starch Wheat
Order of treatments: A. Regular Wheat B. Resistant Starch Wheat
Dietary Supplement: Resistant Starch Wheat
The investigators will be testing high amylose wheat varieties developed by Arcadia Biosciences that have high levels of RS in the endosperm, the source of refined flour. Compared to regular wheat varieties with RS levels of less than 1%, Arcadia's wheat varieties contain between 16% and 34% RS.
Changes in Gut Microbiota Composition
Gut microbiota community composition will be determined by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from stool samples
Time frame: Days 1, 7, 22, and 29
Changes in Glucose Metabolism
Fasting and postprandial measures of blood glucose, insulin, GLP-1
Time frame: 0, 1, 2, and 3 hours postprandial
Changes in Gut Microbiota Metabolism
Fasting and postprandial measures of hydrogen and methane in breath
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3 hours postprandial
Changes in Gut Microbiota Metabolism
Fasting and postprandial measures of SCFA and bile acids in plasma
Time frame: 0, 1, 2, and 3 hours postprandial
Evaluation of Consumer Acceptance
Participant-reported liking and taste
Time frame: Days 8 and 30
Dietary Intake
24-hour dietary recalls
Time frame: Days 3, 5, 8, 25, 27, and 30
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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USDA, Western Human Nutrition Research Center