Resistant Starch Wheat for Improved Metabolic Health

Gut Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082131
• Other study ID #: 984621-1
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: April 22, 2019

Study information

• Verified date: May 2019
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

• Pregnant

• Lactating

• Current use of tobacco

• Dietary restrictions that would interfere with consuming the intervention foods

Related Conditions & MeSH terms

• Gut Microbiota
• Metabolic Health
• Metabolism

Intervention

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.

Locations

Country	Name	City	State
United States	Western Human Nutrition Research Center	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Gut Microbiota Composition	Gut microbiota community composition will be determined by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from stool samples	Days 1, 7, 22, and 29
Secondary	Changes in Glucose Metabolism	Fasting and postprandial measures of blood glucose, insulin, GLP-1	0, 1, 2, and 3 hours postprandial
Secondary	Changes in Gut Microbiota Metabolism	Fasting and postprandial measures of hydrogen and methane in breath	0, 0.5, 1, 1.5, 2, 2.5, 3 hours postprandial
Secondary	Changes in Gut Microbiota Metabolism	Fasting and postprandial measures of SCFA and bile acids in plasma	0, 1, 2, and 3 hours postprandial
Secondary	Evaluation of Consumer Acceptance	Participant-reported liking and taste	Days 8 and 30
Secondary	Dietary Intake	24-hour dietary recalls	Days 3, 5, 8, 25, 27, and 30