Gastrointestinal FunctionNCT03910153
Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels
A study testing MSPrebiotic in people with Gastrointestinal Function, run by MSP Starch Products Inc. at 1 site in Canada.
Trial summary
The objective of the study is to investigate the impact of daily consumption of MSPrebiotic at a dosage level of 30 g per day for 12 weeks on gastrointestinal microbiota in the elderly (> 70 years age) and another age group (30 to 50 years). Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Function
- What is being tested?
- MSPrebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2019to 7 Oct 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent (or by the authorized 3rd party).
- Willing to provide stool (2 times) and blood (6 times) samples over the 14 week study period
- Subjects between 30-50 and above 70 years of age
- Subjects willing to provide fasting blood during Screening and weeks 0, 2, 6, 10 and 14 visits
- Female subjects not pregnant or breast feeding
- Female subjects not planning for pregnancy during the study period
Who cannot join
- Crohn's disease or any other inflammatory bowel disease
- Individuals with Lupus, or on cancer chemotherapy
- Pre-diabetes or Diabetes
- Thyroid disease
- Renal disease
- Hepatic disease
Show all 14Show fewer
- Previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery)
- Subjects on probiotic (e.g. yoghurt),
- Subjects on antibiotics at time of recruitment or on antibiotics within the previous five weeks
- Individuals experiencing dysphagia
- Subjects using additional fiber supplements
- Subjects on digestants, emetics and antiemetics, medications for acid peptic disease and antacids.
- Subjects allergic to potato or corn
- Have conditions, factors, medication (other than those listed above) that the Investigator believes may affect the response of the gut or the interpretation of the test results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of MSPrebiotic Digestion Resistant Starch on Gastrointestinal Function and Blood Glucose Levels
The objective of the study is to investigate the impact of daily consumption of MSPrebiotic at a dosage level of 30 g per day for 12 weeks on gastrointestinal microbiota in the elderly (> 70 years age) and another age group (30 to 50 years). In addition, impact of MSPrebiotic on short chain fatty acids, glucose and insulin levels as well as metabolomic changes will also be studied. A randomized, double-blinded study will be conducted to assess the health benefits of MSPrebiotic and compared with a placebo. This study will provide substantiation for a beneficial effect of MSPrebiotic resistant starch on gut microbiome.
- Conditions
- Gastrointestinal Function
- Being tested
- MSPrebiotic, Placebo
- Keywords
- Prebiotic, Potato Starch, Resistant Starch, MSPrebiotic, Gut Health, Microbiome, Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSPrebioticDietary supplement
MSPrebiotic digestion resistant starch from potatoes (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the potato resistant starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.
PlaceboOther
Corn starch (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the corn starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.
| Study group | Role | What they receive |
|---|---|---|
| Placebo - (Age 30-50 years) | Placebo comparator | Not described Receives: Other: Placebo |
| MSPrebiotic - (Age 30-50 years) | Experimental | Not described Receives: Dietary Supplement: MSPrebiotic |
| Placebo - (Aged 70 years and above) | Placebo comparator | Not described Receives: Other: Placebo |
| MSPrebiotic - (Aged 70 years and above) | Experimental | Not described Receives: Dietary Supplement: MSPrebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in gut microbiome
Gut microbiome composition (ratio between number of Firmicutes and Bacteroides) will be measured using 16S ribosomal ribonucleic acid (rRNA) gene sequencing in stool samples
Measured: 0 and 14 weeks
Changes from baseline in concentration of short chain fatty acids in stool samples
Concentration of short chain fatty acids (acetate, propionate, butyrate, isobutyrate, valerate,isovalerate) in feces will be measured using gas chromatographic method
Measured: 0 and 14 weeks
Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency
Number of bowel movements will be measured using questionnaire. Stool consistency will be measured using questionnaires recording Bristol score. Bristol stool chart indicates the following types: Type 1-Separate hard lumps, like nuts; Type 2-Sausage-shaped but lumpy; Type 3-Like a sausage but with cracks on its surface; Type 4-Like a sausage or snake, smooth and soft; Type 5-Soft blobs with clear-cut edges (passed easily); Type 6-Fluffy pieces with ragged edges, a mushy stool; Type 7-Watery, no solid pieces. Entirely liquid.
Measured: 0, 2, 6,10 and 14 weeks
Changes from baseline in blood glucose concentrations
Blood glucose levels concentrations will be measured using standard laboratory methods
Measured: 0, 2, 6,10 and 14 weeks
Changes from baseline in blood insulin concentrations
Blood insulin concentrations will be measured using standard laboratory methods
Measured: 0 and 14 weeks
Secondary outcomes (4)
Changes from baseline in tolerability in terms of excessive flatulence, abdominal pain, and bloating: questionnaires
Tolerability of consuming MSPrebiotic in terms of excessive flatulence, abdominal pain, and bloating will be measured using questionnaires. The questionnaire will record the severity of flatulence, abdominal pain and bloating on a scale of 1 to 5 where 1=none and 5=extreme.
Measured: 0, 2, 6,10 and 14 weeks
Changes from baseline in overall health in terms of outpatient visits and hospitalizations
Overall health will be measured using questionnaires on outpatient visits and hospitalizations. The questionnaire contains Yes/No question to record if the subject had any outpatient visits or hospitalizations.
Measured: 0, 2, 6,10 and 14 weeks
Changes from baseline in concentration of blood lipids and C-reactive protein Inflammatory marker C-reactive protein. Metabolomic changes
Concentration of blood lipids and C-reactive protein will be measured using standard laboratory methods.
Measured: 0 and14 weeks
Changes from baseline in concentration of blood and fecal Metabolomics
Concentration of blood and fecal metabolomics will be measured using reverse phase liquid chromatography quadrupole time of flight tandem mass spectroscopy (RPLC-QTOF-MS/MS)
Measured: 0 and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start8 Apr 2019
- Primary completion7 Oct 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal FunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- MSP Starch Products Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Source Nutraceutical, Inc.
- Responsible party
- Sponsor
- Investigators
- Nalini Kaul, PhD, Principal investigator, Source Nutraceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910153
- Sponsor's protocol ID
- MSPCT2
- Status last verified
- Jan 2022
- First submitted
- 5 Apr 2019
- Last updated
- 25 Jan 2022
- 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of MSPrebiotic Digestion Resistant Starch on Gastrointestinal Function and Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT03910153
- Acronym / sponsor ID
- MSPCT2
- Conditions
- Gastrointestinal Function
- Keywords
- Prebiotic, Potato Starch, Resistant Starch, MSPrebiotic, Gut Health, Microbiome, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- MSP Starch Products Inc.Industry (pharma, biotech, devices)
- Collaborators
- Source Nutraceutical, Inc.
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 10 Apr 2019 (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 the study is to investigate the impact of daily consumption of MSPrebiotic at a dosage level of 30 g per day for 12 weeks on gastrointestinal microbiota in the elderly (> 70 years age) and another age group (30 to 50 years). In addition, impact of MSPrebiotic on short chain fatty acids, glucose and insulin levels as well as metabolomic changes will also be studied. A randomized, double-blinded study will be conducted to assess the health benefits of MSPrebiotic and compared with a placebo. This study will provide substantiation for a beneficial effect of MSPrebiotic resistant starch on gut microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo - (Age 30-50 years) | Placebo comparator | Other: Placebo |
| MSPrebiotic - (Age 30-50 years) | Experimental | Dietary Supplement: MSPrebiotic |
| Placebo - (Aged 70 years and above) | Placebo comparator | Other: Placebo |
| MSPrebiotic - (Aged 70 years and above) | Experimental | Dietary Supplement: MSPrebiotic |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to provide written informed consent (or by the authorized 3rd party).
- Willing to provide stool (2 times) and blood (6 times) samples over the 14 week study period
- Subjects between 30-50 and above 70 years of age
- Subjects willing to provide fasting blood during Screening and weeks 0, 2, 6, 10 and 14 visits
- Female subjects not pregnant or breast feeding
Key exclusion criteria (14 listed)
- Crohn's disease or any other inflammatory bowel disease
- Individuals with Lupus, or on cancer chemotherapy
- Pre-diabetes or Diabetes
- Thyroid disease
- Renal disease
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 |
|---|---|---|
| MSPrebioticMSPrebiotic digestion resistant starch from potatoes (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the potato resistant starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications. | Dietary supplement | MSPrebiotic - (Age 30-50 years), MSPrebiotic - (Aged 70 years and above) |
| PlaceboCorn starch (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the corn starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications. | Other | Placebo - (Age 30-50 years), Placebo - (Aged 70 years and above) |
Primary outcome
Changes from baseline in gut microbiome
Time frame: 0 and 14 weeks
Gut microbiome composition (ratio between number of Firmicutes and Bacteroides) will be measured using 16S ribosomal ribonucleic acid (rRNA) gene sequencing in stool samples
Changes from baseline in concentration of short chain fatty acids in stool samples
Time frame: 0 and 14 weeks
Concentration of short chain fatty acids (acetate, propionate, butyrate, isobutyrate, valerate,isovalerate) in feces will be measured using gas chromatographic method
Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency
Time frame: 0, 2, 6,10 and 14 weeks
Number of bowel movements will be measured using questionnaire. Stool consistency will be measured using questionnaires recording Bristol score. Bristol stool chart indicates the following types: Type 1-Separate hard lumps, like nuts; Type 2-Sausage-shaped but lumpy; Type 3-Like a sausage but with cracks on its surface; Type 4-Like a sausage or snake, smooth and soft; Type 5-Soft blobs with clear-cut edges (passed easily); Type 6-Fluffy pieces with ragged edges, a mushy stool; Type 7-Watery, no solid pieces. Entirely liquid.
Changes from baseline in blood glucose concentrations
Time frame: 0, 2, 6,10 and 14 weeks
Blood glucose levels concentrations will be measured using standard laboratory methods
Changes from baseline in blood insulin concentrations
Time frame: 0 and 14 weeks
Blood insulin concentrations will be measured using standard laboratory methods
4 secondary outcomes
Changes from baseline in tolerability in terms of excessive flatulence, abdominal pain, and bloating: questionnaires
Time frame: 0, 2, 6,10 and 14 weeks
Changes from baseline in overall health in terms of outpatient visits and hospitalizations
Time frame: 0, 2, 6,10 and 14 weeks
Changes from baseline in concentration of blood lipids and C-reactive protein Inflammatory marker C-reactive protein. Metabolomic changes
Time frame: 0 and14 weeks
Changes from baseline in concentration of blood and fecal Metabolomics
Time frame: 0 and 14 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 25 Jan 2022.
- 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.
Nalini Kaul, PhD principal investigator
Source Nutraceutical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSPrebiotic in people with Gastrointestinal Function, 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 6 inclusion and 14 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 25 Jan 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 from baseline in gut microbiome (time frame: 0 and 14 weeks). The study lists 5 primary outcomes in all. 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 25 Jan 2022.