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.
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
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.
- Conditions
- Gut Microbiota, Metabolism, Metabolic Health
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Order of treatments:
A. Resistant Starch Wheat B. Regular Wheat Receives: Dietary Supplement: Resistant Starch Wheat |
| Group 2 | Experimental | Order 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.
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)
Changes in Glucose Metabolism
Fasting and postprandial measures of blood glucose, insulin, GLP-1
Measured: 0, 1, 2, and 3 hours postprandial
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
Changes in Gut Microbiota Metabolism
Fasting and postprandial measures of SCFA and bile acids in plasma
Measured: 0, 1, 2, and 3 hours postprandial
Evaluation of Consumer Acceptance
Participant-reported liking and taste
Measured: Days 8 and 30
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.
- First posted17 Mar 2017
- Study start22 May 2017
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Starch Wheat for Improved Metabolic Health: A Proof of Concept Study in Human Subjects
- ClinicalTrials.gov ID
- NCT03082131
- Acronym / sponsor ID
- 984621-1
- Conditions
- Gut Microbiota, Metabolism, Metabolic Health
- Keywords
- Gut Microbiota, Glycemic Response, Resistant Starch, Fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- University of California, Davis
- Study start
- 22 May 2017 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, cross-over design consisting of two 1-week dietary intervention periods as well as a 2-week washout period in between
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Resistant Starch WheatOrder of treatments: A. Resistant Starch Wheat B. Regular Wheat |
| Group 2 | Experimental | Dietary Supplement: Resistant Starch WheatOrder of treatments: A. Regular Wheat B. Resistant Starch Wheat |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults. Healthy means that the candidate reports that s/he feels well and can perform normal activities.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant Starch WheatThe 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. | Dietary supplement | Group 1, Group 2 |
Primary outcome
Changes in Gut Microbiota Composition
Time frame: Days 1, 7, 22, and 29
Gut microbiota community composition will be determined by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from stool samples
5 secondary outcomes
Changes in Glucose Metabolism
Time frame: 0, 1, 2, and 3 hours postprandial
Changes in Gut Microbiota Metabolism
Time frame: 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
Evaluation of Consumer Acceptance
Time frame: Days 8 and 30
Dietary Intake
Time frame: Days 3, 5, 8, 25, 27, and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.