Focus of Study; Impact of MSPrebiotic on Gastrointestinal MicrobiotaNCT01977183
Effects of MSPrebiotic on Gut Health in the Elderly
A study testing MSPrebiotic in people with Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota, run by St. Boniface Hospital at 2 sites in Canada.
Trial summary
The purpose of this clinical trial is to study the effects of potato resistant starch on the microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels will be measured and compared between elderly adults and in pre-elderly, adults from the general public. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota
- What is being tested?
- MSPrebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2013to Jun 2016
- 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
- Willing to provide stool and blood specimens 5 times over the 14 week study period
- Subjects ≥ 70 years of age
- Subjects 30-50 years of age
Who cannot join
- Pregnancy
- Crohn's disease or any other inflammatory bowel disease
- Individuals with Lupus, or on cancer chemotherapy
- Pre-diabetes or Diabetes
- Thyroid disease
- Renal disease
Show all 13Show fewer
- Hepatic disease
- Previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery)
- Subjects on probiotic
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Boniface Hosptial Research Centre
Winnipeg, Manitoba, R2H 2A6
Deer Lodge Centre
Winnipeg, Manitoba, R3J 0L3
About this study
The purpose of this clinical trial is to study the effects of potato resistant starch on the microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels will be measured and compared between elderly adults and in pre-elderly, adults from the general public. A correlation between the use of potato resistant starch and specific clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from the general public will be studied.
Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years) is less diverse and more prone to imbalance compared to adults (30-50 years) from the general population and that this imbalance of the gut microflora in the elderly adults is partially related to inadequate RS in their diet.
Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the general population), thereby improving gut health and reducing the risk of diarrhea and/or gut infection.
Read the detailed description
To assess the impact on the potato resistant starch on the microbiota, pyrosequencing will be performed on stool samples to determine the original composition and assess any changes over the study period. In addition the impact of the potato resistant starch on inflammatory markers will be assess through blood samples collected over the study period.
- Being tested
- MSPrebiotic, Placebo
- Keywords
- gastrointestinal, microbiome, prebiotic, starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSPrebioticDietary supplement
Also called Potato Resistant Starch
Potato Resistant Starch
PlaceboDietary supplement
Placebo - Corn Starch
| Study group | Role | What they receive |
|---|---|---|
| Elderly adults with MSPrebiotic | Experimental | 30 g of MSPrebiotic (potato resistant starch) per day taken with 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi-solid food. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. Receives: Dietary Supplement: MSPrebiotic |
| Elderly adults with Placebo | Placebo comparator | 30 g of corn starch per day taken with 1 glass (approximately 250 mL) of non-heated fluid or or non-heated semi-solid food. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. Receives: Dietary Supplement: Placebo |
| General adult population with MSPrebiotic | Experimental | 30 g of MSPrebiotic (potato resistant starch) per day taken with 1 glass (approximately 250 mL) of non-heated fluid. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. Receives: Dietary Supplement: MSPrebiotic |
| General adult population with Placebo | Placebo comparator | 30 g of corn starch per day taken with 1 glass (approximately 250 mL) of non-heated fluid. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of 30g dose of MSPrebiotic
Changes from baseline in the tolerability of ingestion of 30 g once/day of MSPrebiotic with respect to gastrointestinal side effects (excessive flatulence, changes in bowel movements, abdominal pain and bloating) at 2, 6, 10 and 14 weeks.
Measured: 2, 6, 10 and 14 weeks
Gut health improvements
Changes from baseline in gut health improvements including: reduced constipation (i.e. improved ease of bowel movements without stool softeners), microbiome composition (i.e. favourable Firmicutes to Bacteroides ratio) at 2, 6, 10 and 14 weeks.
Measured: 2, 6, 10 and 14 weeks
Levels of short chain fatty acids in stool and lipid level in blood
Changes from baseline of short chain fatty acid levels in stool including; acetate, propionate, butyrate, isobutyrate, valerate, isovalerate at 2, 4, 6, 10 and 14 weeks.
Measured: 2, 4, 6, 10 and 14 weeks
Inflammatory marker
Changes from baseline of Inflammatory marker (IL-10, C-reactive protein, TNFα) levels in blood at 2, 6, 10 and 14 weeks.
Measured: 2, 6, 10 and 14 weeks
Secondary outcomes (1)
Changes from baseline in overall health at 2, 6, 10 and 14 weeks
This will be assessed based on completion of a daily health log that assesses a wide variety of parameters.
Measured: 2, 6, 10 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 posted6 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Focus of Study; Impact of MSPrebiotic on Gastrointestinal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Microbiology Laboratory, Canada, MSP Starch Products Inc.
- Responsible party
- Sponsor
- Investigators
- Michelle J Alfa, PhD, Principal investigator, St. Boniface Hospital Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977183
- Sponsor's protocol ID
- RRC/2013/1285
- Other IDs
- B2013:016
- Status last verified
- Jul 2015
- First submitted
- 11 Oct 2013
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bush JR, Alfa MJ. Increasing levels of Parasutterella in the gut microbiome correlate with improving low-density lipoprotein levels in healthy adults consuming resistant potato starch during a randomised trial. BMC Nutr. 2020 Dec 11;6(1):72. doi: 10.1186/s40795-020-00398-9.
PubMed 33303023Alfa MJ, Strang D, Tappia PS, Olson N, DeGagne P, Bray D, Murray BL, Hiebert B. A Randomized Placebo Controlled Clinical Trial to Determine the Impact of Digestion Resistant Starch MSPrebiotic(R) on Glucose, Insulin, and Insulin Resistance in Elderly and Mid-Age Adults. Front Med (Lausanne). 2018 Jan 22;4:260. doi: 10.3389/fmed.2017.00260. eCollection 2017.
PubMed 29410955Alfa MJ, Strang D, Tappia PS, Graham M, Van Domselaar G, Forbes JD, Laminman V, Olson N, DeGagne P, Bray D, Murray BL, Dufault B, Lix LM. A randomized trial to determine the impact of a digestion resistant starch composition on the gut microbiome in older and mid-age adults. Clin Nutr. 2018 Jun;37(3):797-807. doi: 10.1016/j.clnu.2017.03.025. Epub 2017 Mar 31.
PubMed 28410921
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of MSPrebiotic on Gut Health in the Elderly
- ClinicalTrials.gov ID
- NCT01977183
- Acronym / sponsor ID
- RRC/2013/1285
- Keywords
- gastrointestinal, microbiome, prebiotic, starch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- National Microbiology Laboratory, Canada, MSP Starch Products Inc.
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Nov 2013 (estimated)
- 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 purpose of this clinical trial is to study the effects of potato resistant starch on the microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels will be measured and compared between elderly adults and in pre-elderly, adults from the general public. A correlation between the use of potato resistant starch and specific clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from the general public will be studied.
Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years) is less diverse and more prone to imbalance compared to adults (30-50 years) from the general population and that this imbalance of the gut microflora in the elderly adults is partially related to inadequate RS in their diet.
Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the general population), thereby improving gut health and reducing the risk of diarrhea and/or gut infection.
Detailed description
To assess the impact on the potato resistant starch on the microbiota, pyrosequencing will be performed on stool samples to determine the original composition and assess any changes over the study period. In addition the impact of the potato resistant starch on inflammatory markers will be assess through blood samples collected over the study period.
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 |
|---|---|---|
| Elderly adults with MSPrebiotic | Experimental | Dietary Supplement: MSPrebiotic30 g of MSPrebiotic (potato resistant starch) per day taken with 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi-solid food. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. |
| Elderly adults with Placebo | Placebo comparator | Dietary Supplement: Placebo30 g of corn starch per day taken with 1 glass (approximately 250 mL) of non-heated fluid or or non-heated semi-solid food. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. |
| General adult population with MSPrebiotic | Experimental | Dietary Supplement: MSPrebiotic30 g of MSPrebiotic (potato resistant starch) per day taken with 1 glass (approximately 250 mL) of non-heated fluid. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. |
| General adult population with Placebo | Placebo comparator | Dietary Supplement: Placebo30 g of corn starch per day taken with 1 glass (approximately 250 mL) of non-heated fluid. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent
- Willing to provide stool and blood specimens 5 times over the 14 week study period
- Subjects ≥ 70 years of age
- Subjects 30-50 years of age
Key exclusion criteria (13 listed)
- Pregnancy
- Crohn's disease or any other inflammatory bowel disease
- Individuals with Lupus, or on cancer chemotherapy
- Pre-diabetes or Diabetes
- Thyroid 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 |
|---|---|---|
| MSPrebioticAlso: Potato Resistant StarchPotato Resistant Starch | Dietary supplement | Elderly adults with MSPrebiotic, General adult population with MSPrebiotic |
| PlaceboPlacebo - Corn Starch | Dietary supplement | Elderly adults with Placebo, General adult population with Placebo |
Primary outcome
Tolerability of 30g dose of MSPrebiotic
Time frame: 2, 6, 10 and 14 weeks
Changes from baseline in the tolerability of ingestion of 30 g once/day of MSPrebiotic with respect to gastrointestinal side effects (excessive flatulence, changes in bowel movements, abdominal pain and bloating) at 2, 6, 10 and 14 weeks.
Gut health improvements
Time frame: 2, 6, 10 and 14 weeks
Changes from baseline in gut health improvements including: reduced constipation (i.e. improved ease of bowel movements without stool softeners), microbiome composition (i.e. favourable Firmicutes to Bacteroides ratio) at 2, 6, 10 and 14 weeks.
Levels of short chain fatty acids in stool and lipid level in blood
Time frame: 2, 4, 6, 10 and 14 weeks
Changes from baseline of short chain fatty acid levels in stool including; acetate, propionate, butyrate, isobutyrate, valerate, isovalerate at 2, 4, 6, 10 and 14 weeks.
Inflammatory marker
Time frame: 2, 6, 10 and 14 weeks
Changes from baseline of Inflammatory marker (IL-10, C-reactive protein, TNFα) levels in blood at 2, 6, 10 and 14 weeks.
1 secondary outcome
Changes from baseline in overall health at 2, 6, 10 and 14 weeks
Time frame: 2, 6, 10 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 6 Jan 2023.
- Derived from this study: PubMed 33303023Bush JR, Alfa MJ. Increasing levels of Parasutterella in the gut microbiome correlate with improving low-density lipoprotein levels in healthy adults consuming resistant potato starch during a randomised trial. BMC Nutr. 2020 Dec 11;6(1):72. doi: 10.1186/s40795-020-00398-9.
- Derived from this study: PubMed 29410955Alfa MJ, Strang D, Tappia PS, Olson N, DeGagne P, Bray D, Murray BL, Hiebert B. A Randomized Placebo Controlled Clinical Trial to Determine the Impact of Digestion Resistant Starch MSPrebiotic(R) on Glucose, Insulin, and Insulin Resistance in Elderly and Mid-Age Adults. Front Med (Lausanne). 2018 Jan 22;4:260. doi: 10.3389/fmed.2017.00260. eCollection 2017.
- Derived from this study: PubMed 28410921Alfa MJ, Strang D, Tappia PS, Graham M, Van Domselaar G, Forbes JD, Laminman V, Olson N, DeGagne P, Bray D, Murray BL, Dufault B, Lix LM. A randomized trial to determine the impact of a digestion resistant starch composition on the gut microbiome in older and mid-age adults. Clin Nutr. 2018 Jun;37(3):797-807. doi: 10.1016/j.clnu.2017.03.025. Epub 2017 Mar 31.
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.
Michelle J Alfa, PhD principal investigator
St. Boniface Hospital Research Centre
2 sites 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 Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota, run by St. Boniface Hospital at 2 sites 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 4 inclusion and 13 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Tolerability of 30g dose of MSPrebiotic (time frame: 2, 6, 10 and 14 weeks). The study lists 4 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 NCT01977183, which also lists 3 linked publications.
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 6 Jan 2023.