MicrobiotaNCT05242913
Effects of Resistant Potato Starch on the Gut Microbiota
A study testing Resistant Potato Starch in people with Microbiota, run by MSP Starch Products Inc. at 1 site in Canada.
Trial summary
This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- Resistant Potato Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 30 Oct 2019to 6 Jan 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 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18.0 and 34.9 kg/square meter (inclusive) that were generally healthy as determined by medical history and screening blood work.
Who cannot join
- Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Nutrasource Pharmaceutical and Nutraceutical Services
Guelph, Ontario, N1G 0B4
About this study
Official title: A Randomized Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Resistant Potato Starch (SolnulTM) on Intestinal Flora
This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults.
- Conditions
- Microbiota
- Being tested
- Resistant Potato Starch, Placebo
- Keywords
- Microbiota, Resistant Potato Starch, Bristol Stool Chart, Diarrhea, Constipation, Bloating, Abdominal Pain, Gas, Well-being
- Medical subject headings
- Diarrhea, Constipation, Abdominal Pain, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant Potato StarchDietary supplement
Also called Solnul, MSPrebiotic
Unmodified potato starch containing >60% resistant starch Type 2
PlaceboDietary supplement
Also called AmiocaTM
Fully digestible corn starch
| Study group | Role | What they receive |
|---|---|---|
| High Dose SolnulTM | Active comparator | 7.0 g of Resistant Potato Starch administered daily for 4 weeks Receives: Dietary Supplement: Resistant Potato Starch |
| Low Dose SolnulTM | Active comparator | 3.5 g of Resistant Potato Starch (plus 3.5 g digestible corn starch for 7.0 g total carbohydrate) administered daily for 4 weeks Receives: Dietary Supplement: Resistant Potato Starch |
| Placebo | Placebo comparator | 7.0 g digestible corn starch administered daily for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
Changes in relative abundance of Bifidobacterium after 4 weeks of consumption in High Dose, Low Dose, and placebo arms are compared.
Measured: Four weeks
Secondary outcomes (5)
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
Changes in relative abundance of Bifidobacterium after 1 week of consumption in High Dose, Low Dose, and placebo arms are compared.
Measured: One week
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups
Changes in relative abundance of Bifidobacterium between baseline and one or four week timepoints for High Dose, Low Dose, and Placebo arms.
Measured: One week, four weeks
Fecal SCFA (mmol/kg stool) changes from baseline
Between and within group comparisons of SCFA levels in stool for High Dose, Low Dose, and Placebo arms
Measured: One week, four weeks
Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores
Changes in constipation and diarrhea frequency in High Dose, Low Dose, and Placebo arms.
Measured: One week, four weeks
Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale
Changes in bloating, belching, abdominal pain, gas, and overall well-being in High Dose, Low Dose, and Placebo arms.
Measured: One week, four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start30 Oct 2019
- Primary completion6 Jan 2020
- Study completion6 Jan 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 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- MSP Starch Products Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Beir, MD, Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242913
- Sponsor's protocol ID
- R10356
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bush JR, Alfa MJ. Consumption of resistant potato starch produces changes in gut microbiota that correlate with improvements in abnormal bowel symptoms: a secondary analysis of a clinical trial. BMC Nutr. 2024 Nov 27;10(1):152. doi: 10.1186/s40795-024-00962-7.
PubMed 39605008
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Resistant Potato Starch (SolnulTM) on Intestinal Flora
- ClinicalTrials.gov ID
- NCT05242913
- Acronym / sponsor ID
- R10356
- Conditions
- Microbiota
- Keywords
- Microbiota, Resistant Potato Starch, Bristol Stool Chart, Diarrhea, Constipation, Bloating, Abdominal Pain, Gas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- MSP Starch Products Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 16 Feb 2022 (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.
This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose SolnulTM | Active comparator | Dietary Supplement: Resistant Potato Starch7.0 g of Resistant Potato Starch administered daily for 4 weeks |
| Low Dose SolnulTM | Active comparator | Dietary Supplement: Resistant Potato Starch3.5 g of Resistant Potato Starch (plus 3.5 g digestible corn starch for 7.0 g total carbohydrate) administered daily for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo7.0 g digestible corn starch administered daily for 4 weeks |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI between 18.0 and 34.9 kg/square meter (inclusive) that were generally healthy as determined by medical history and screening blood work.
Key exclusion criteria (1 listed)
- Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.
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 Potato StarchAlso: Solnul, MSPrebioticUnmodified potato starch containing >60% resistant starch Type 2 | Dietary supplement | High Dose SolnulTM, Low Dose SolnulTM |
| PlaceboAlso: AmiocaTMFully digestible corn starch | Dietary supplement | Placebo |
Primary outcome
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
Time frame: Four weeks
Changes in relative abundance of Bifidobacterium after 4 weeks of consumption in High Dose, Low Dose, and placebo arms are compared.
5 secondary outcomes
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
Time frame: One week
Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups
Time frame: One week, four weeks
Fecal SCFA (mmol/kg stool) changes from baseline
Time frame: One week, four weeks
Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores
Time frame: One week, four weeks
Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale
Time frame: One week, four weeks
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 16 Feb 2022.
- Derived from this study: PubMed 39605008Bush JR, Alfa MJ. Consumption of resistant potato starch produces changes in gut microbiota that correlate with improvements in abnormal bowel symptoms: a secondary analysis of a clinical trial. BMC Nutr. 2024 Nov 27;10(1):152. doi: 10.1186/s40795-024-00962-7.
- 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.
Anthony Beir, MD principal investigator
Nutrasource Pharmaceutical and Nutraceutical Services
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 Potato Starch in people with Microbiota, run by MSP Starch Products Inc. at 1 site in Canada.
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 1 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 16 Feb 2022. 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 Canada. 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. Some participants in this study may receive a placebo. 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 relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups (time frame: Four weeks). 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 NCT05242913, 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 16 Feb 2022.