Healthy VolunteersNCT05743790
The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption
A study of Healthy Volunteers, run by Cornell University at 1 site in United States.
Trial summary
Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 15 Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years of age
- Willing to consume the supplements provided throughout the duration of the study
Who cannot join
- History of diabetes, prediabetes or impaired glucose tolerance.
- Existing, UNTREATED, thyroid condition.
- Usage of systemic antibiotics (intravenous injection, intramuscular, or oral) within 6 months prior to the study.
- Acute disease at the time of enrollment.
- Chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.
- History of active UNTREATED gastrointestinal disorders or diseases including:
Show all 10Show fewer
- Inflammatory bowel disease (IBD) ii. Ulcerative colitis (mild-moderate-severe) iii. Crohn's disease (mild- moderate-severe) iv. Indeterminate colitis v. Irritable bowel syndrome (IBS) (moderate-severe) vi. Persistent, infectious gastroenteritis, colitis or gastritis vii. Persistent or chronic diarrhea of unknown etiology viii. Clostridium difficile infection (recurrent) ix. Chronic constipation
- Suspected state of immunosuppression or immunodeficiency including HIV.
- History of bariatric surgery.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Consequently, everyone may not reap the same health benefits by eating high amounts of RS. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes respond to RS supplementation would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber intake. The objective of this study was to evaluate candidate predictors of gut microbiota response to RS supplementation.
- Conditions
- Healthy Volunteers
- Being tested
- RS2-control-RS4, RS4-control-RS2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS2-control-RS4Dietary supplement
Group A: Treatment 1 = RS2 (Hi-Maize 260), Treatment 2 = Control (Amioca TF), Treatment 3 = RS4 (Versafibe 1490)
RS4-control-RS2Dietary supplement
Group B: Treatment 1 = RS4 (Versafibe 1490), Treatment 2 = Control (Amioca TF), Treatment 3 = RS2 (Hi-Maize 260)
| Study group | Role | What they receive |
|---|---|---|
| Group A: RS2 first | Experimental | Crackers were provided during each of 3 treatment periods in a crossover design. The 3 types of crackers were matched for total carbohydrate content. Treatment period 1 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 2 (30g/day) for 7 days; Treatment period 2 (10 days): Participants received control crackers with 100% digestible starch; Treatment period 3 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 4 (30g/day) for 7 days. There were 5-day washout periods between the treatment periods. Receives: Dietary Supplement: RS2-control-RS4 |
| Group B: RS4 first | Experimental | Crackers were provided during each of 3 treatment periods in a crossover design. The 3 types of crackers were matched for total carbohydrate content. Treatment period 1 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 4 (30g/day) for 7 days; Treatment period 2 (10 days): Participants received control crackers with 100% digestible starch; Treatment period 3 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 2 (30g/day) for 7 days. There were 5-day washout periods between the treatment periods. Receives: Dietary Supplement: RS4-control-RS2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome
16S rRNA gene survey of gut microbial communities
Measured: 7 weeks
Fecal short-chain fatty acid concentration
Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start26 Sep 2019
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We originally enrolled 196 participants and collected saliva samples for screening to participate in the intervention. Then we enrolled 76 participants in the intervention study. These participants were randomly assigned to one of two parallel arms in the intervention study.
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743790
- Sponsor's protocol ID
- 1902008575
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Piperni E, Blanco-Miguez A, Mengoni C, Piccinno G, Puncochar M, Ren J, Segata N, Asnicar F, Poole AC. Resistant starch types 2 and 4 induce distinct and reversible changes in the human gut microbiome. Microbiol Spectr. 2026 Jul 24:e0076326. doi: 10.1128/spectrum.00763-26. Online ahead of print.
PubMed 42496113
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption
- ClinicalTrials.gov ID
- NCT05743790
- Acronym / sponsor ID
- 1902008575
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 24 Feb 2023 (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.
Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Consequently, everyone may not reap the same health benefits by eating high amounts of RS. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes respond to RS supplementation would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber intake. The objective of this study was to evaluate candidate predictors of gut microbiota response to RS supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We originally enrolled 196 participants and collected saliva samples for screening to participate in the intervention. Then we enrolled 76 participants in the intervention study. These participants were randomly assigned to one of two parallel arms in the intervention study.
| Arm | Type | Receives |
|---|---|---|
| Group A: RS2 first | Experimental | Dietary Supplement: RS2-control-RS4Crackers were provided during each of 3 treatment periods in a crossover design. The 3 types of crackers were matched for total carbohydrate content. Treatment period 1 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 2 (30g/day) for 7 days; Treatment period 2 (10 days): Participants received control crackers with 100% digestible starch; Treatment period 3 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 4 (30g/day) for 7 days. There were 5-day washout periods between the treatment periods. |
| Group B: RS4 first | Experimental | Dietary Supplement: RS4-control-RS2Crackers were provided during each of 3 treatment periods in a crossover design. The 3 types of crackers were matched for total carbohydrate content. Treatment period 1 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 4 (30g/day) for 7 days; Treatment period 2 (10 days): Participants received control crackers with 100% digestible starch; Treatment period 3 (10 days): After a 3-day ramp up, participants received 120g of crackers/day containing resistant starch type 2 (30g/day) for 7 days. There were 5-day washout periods between the treatment periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18 years of age
- Willing to consume the supplements provided throughout the duration of the study
Key exclusion criteria (10 listed)
- History of diabetes, prediabetes or impaired glucose tolerance.
- Existing, UNTREATED, thyroid condition.
- Usage of systemic antibiotics (intravenous injection, intramuscular, or oral) within 6 months prior to the study.
- Acute disease at the time of enrollment.
- Chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.
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 |
|---|---|---|
| RS2-control-RS4Group A: Treatment 1 = RS2 (Hi-Maize 260), Treatment 2 = Control (Amioca TF), Treatment 3 = RS4 (Versafibe 1490) | Dietary supplement | Group A: RS2 first |
| RS4-control-RS2Group B: Treatment 1 = RS4 (Versafibe 1490), Treatment 2 = Control (Amioca TF), Treatment 3 = RS2 (Hi-Maize 260) | Dietary supplement | Group B: RS4 first |
Primary outcome
Gut microbiome
Time frame: 7 weeks
16S rRNA gene survey of gut microbial communities
Fecal short-chain fatty acid concentration
Time frame: 7 weeks
Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography
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 3 Apr 2023.
- Derived from this study: PubMed 42496113Piperni E, Blanco-Miguez A, Mengoni C, Piccinno G, Puncochar M, Ren J, Segata N, Asnicar F, Poole AC. Resistant starch types 2 and 4 induce distinct and reversible changes in the human gut microbiome. Microbiol Spectr. 2026 Jul 24:e0076326. doi: 10.1128/spectrum.00763-26. Online ahead of print.
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Screening Protocol
Pain
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 of Healthy Volunteers, run by Cornell University 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 2 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 3 Apr 2023. 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?
Gut microbiome (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05743790, which also lists 1 linked publication.
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 3 Apr 2023.