Gut Microbiota Clinical Trial
Official title:
Resistant Starch Wheat for Improved Metabolic Health: A Proof of Concept Study in Human Subjects
NCT number | NCT03082131 |
Other study ID # | 984621-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 22, 2017 |
Est. completion date | April 22, 2019 |
Verified date | May 2019 |
Source | USDA, Western Human Nutrition Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Western Human Nutrition Research Center | Davis | California |
Lead Sponsor | Collaborator |
---|---|
USDA, Western Human Nutrition Research Center | University of California, Davis |
United States,
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 |
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