- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03082131
Resistant Starch Wheat for Improved Metabolic Health
Resistant Starch Wheat for Improved Metabolic Health: A Proof of Concept Study in Human Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Davis, California, United States, 95616
- Western Human Nutrition Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Order of treatments: A. Resistant Starch Wheat B. Regular 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.
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Experimental: Group 2
Order of treatments: A. Regular Wheat B. 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Gut Microbiota Composition
Time Frame: Days 1, 7, 22, and 29
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Gut microbiota community composition will be determined by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from stool samples
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Days 1, 7, 22, and 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Glucose Metabolism
Time Frame: 0, 1, 2, and 3 hours postprandial
|
Fasting and postprandial measures of blood glucose, insulin, GLP-1
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0, 1, 2, and 3 hours postprandial
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Changes in Gut Microbiota Metabolism
Time Frame: 0, 0.5, 1, 1.5, 2, 2.5, 3 hours postprandial
|
Fasting and postprandial measures of hydrogen and methane in breath
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0, 0.5, 1, 1.5, 2, 2.5, 3 hours postprandial
|
Changes in Gut Microbiota Metabolism
Time Frame: 0, 1, 2, and 3 hours postprandial
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Fasting and postprandial measures of SCFA and bile acids in plasma
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0, 1, 2, and 3 hours postprandial
|
Evaluation of Consumer Acceptance
Time Frame: Days 8 and 30
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Participant-reported liking and taste
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Days 8 and 30
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Dietary Intake
Time Frame: Days 3, 5, 8, 25, 27, and 30
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24-hour dietary recalls
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Days 3, 5, 8, 25, 27, and 30
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 984621-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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