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CompletedNCT03082131Updated May 7, 2019

Resistant Starch Wheat for Improved Metabolic Health

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

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gut Microbiota
  • Metabolism
  • Metabolic Health

Keywords

  • Gut Microbiota
  • Glycemic Response
  • Resistant Starch
  • Fiber
03

In context

Lead sponsor

USDA, Western Human Nutrition Research Center is the lead sponsor of 53 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Group 1

    Order of treatments: A. Resistant Starch Wheat B. Regular Wheat

    Dietary Supplement: Resistant Starch Wheat

  • Experimental
    Group 2

    Order of treatments: A. Regular Wheat B. Resistant Starch Wheat

    Dietary Supplement: Resistant Starch Wheat

Interventions

  • Dietary supplementResistant 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in Glucose Metabolism

    Fasting and postprandial measures of blood glucose, insulin, GLP-1

    Time frame: 0, 1, 2, and 3 hours postprandial

  2. 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

  3. 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

  4. Evaluation of Consumer Acceptance

    Participant-reported liking and taste

    Time frame: Days 8 and 30

  5. Dietary Intake

    24-hour dietary recalls

    Time frame: Days 3, 5, 8, 25, 27, and 30

07

Study locations

1 site
  • Western Human Nutrition Research Center
    Davis, California 95616, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03082131
Lead sponsor
USDA, Western Human Nutrition Research Center
Collaborators
University of California, Davis
Responsible party
Sponsor
First posted
Mar 17, 2017
Start date
May 22, 2017
Primary completion
Apr 22, 2019
Completion
Apr 22, 2019
Last update
May 7, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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