Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03082131
Study type Interventional
Source USDA, Western Human Nutrition Research Center
Contact
Status Completed
Phase N/A
Start date May 22, 2017
Completion date April 22, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04991792 - Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean Section N/A
Completed NCT02151825 - Effect of a Synbiotic on the Gut Microbiota and Adiposity-related Markers in Healthy Overweight Subjects N/A
Completed NCT01545219 - A Study of a Prebiotic, a Probiotic and a Synbiotic Upon the Gut Microbiota and Immune Response of Healthy Volunteers N/A
Active, not recruiting NCT04435548 - Westlake Gut Microbiome Study
Enrolling by invitation NCT05057039 - The Study of Gut Microbiota in Hypertensive Patients
Not yet recruiting NCT05039060 - Modified MAC Diet and Gut Microbiota in CRC Patients N/A
Completed NCT03746158 - Interindividual Variation in Excretion of Curcumin N/A
Active, not recruiting NCT03266055 - Effects of Blueberry on Gut Microbiota and Metabolic Syndrome N/A
Completed NCT04960878 - The Effect of Synbiotics on the Upper Respiratory Tract Infection N/A
Active, not recruiting NCT05607745 - Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study N/A
Recruiting NCT04120051 - The SIMBA Project - The Effect of a Prebiotic Supplement on Glucose Metabolism and Gut Microbiota in Obese Adults N/A
Not yet recruiting NCT05481866 - Targeting Gut Microbiota and Metabolites for Very Preterm Infants Through Oropharyngeal Administration of Colostrum N/A
Completed NCT03293693 - Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects N/A
Completed NCT02207140 - Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly Phase 0
Recruiting NCT04203459 - The Mechanism of Enhancing the Anti-tumor Effects of CAR-T on PC by Gut Microbiota Regulation
Active, not recruiting NCT03259685 - Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome N/A
Recruiting NCT06157346 - Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
Completed NCT03203044 - Impact of Soylent Consumption on Human Microbiome Composition N/A
Recruiting NCT05975541 - Susceptibility to Infectious Diseases in Obesity
Active, not recruiting NCT05457439 - Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment N/A