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Gut MicrobiotaNCT03082131

Resistant Starch Wheat for Improved Metabolic Health

A study testing Resistant Starch Wheat in people with Gut Microbiota and Metabolism, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gut Microbiota, Metabolism, Metabolic Health
What is being tested?
Resistant Starch Wheat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
22 May 2017to 22 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • Pregnant
  • Lactating
  • Current use of tobacco
  • Dietary restrictions that would interfere with consuming the intervention foods

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Western Human Nutrition Research Center

    Davis, California, 95616

Other trials in United States

About this study

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

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.

Being tested
Resistant Starch Wheat
Keywords
Gut Microbiota, Glycemic Response, Resistant Starch, Fiber

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistant Starch WheatDietary supplement

    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.

Study groups in NCT03082131
Study groupRoleWhat they receive
Group 1ExperimentalOrder of treatments: A. Resistant Starch Wheat B. Regular Wheat
Receives: Dietary Supplement: Resistant Starch Wheat
Group 2ExperimentalOrder of treatments: A. Regular Wheat B. Resistant Starch Wheat
Receives: Dietary Supplement: Resistant Starch Wheat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Gut Microbiota Composition

    Gut microbiota community composition will be determined by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from stool samples

    Measured: Days 1, 7, 22, and 29

Secondary outcomes (5)
  1. Changes in Glucose Metabolism

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

    Measured: 0, 1, 2, and 3 hours postprandial

  2. Changes in Gut Microbiota Metabolism

    Fasting and postprandial measures of hydrogen and methane in breath

    Measured: 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

    Measured: 0, 1, 2, and 3 hours postprandial

  4. Evaluation of Consumer Acceptance

    Participant-reported liking and taste

    Measured: Days 8 and 30

  5. Dietary Intake

    24-hour dietary recalls

    Measured: Days 3, 5, 8, 25, 27, and 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2017
  2. Study start22 May 2017
  3. Primary completion22 Apr 2019
  4. Study completion22 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, cross-over design consisting of two 1-week dietary intervention periods as well as a 2-week washout period in between
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03082131
Sponsor's protocol ID
984621-1
Status last verified
May 2019
First submitted
10 Mar 2017
Last updated
7 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Resistant Starch Wheat in people with Gut Microbiota and Metabolism, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Gut Microbiota Composition (time frame: Days 1, 7, 22, and 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.

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