Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of MSPrebiotic on Gut Health in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01977183
Recruitment Status : Unknown
Verified July 2015 by Dr. Michelle Alfa, St. Boniface Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 6, 2013
Last Update Posted : July 20, 2015
Sponsor:
Collaborators:
Deer Lodge Centre
National Microbiology Laboratory, Canada
Manitoba Starch Products
Information provided by (Responsible Party):
Dr. Michelle Alfa, St. Boniface Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota Dietary Supplement: MSPrebiotic Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of MSPrebiotic on Gut Health in the Elderly
Study Start Date : September 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arm Intervention/treatment
Experimental: Elderly adults with MSPrebiotic
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.
Dietary Supplement: MSPrebiotic
Potato Resistant Starch
Other Name: Potato Resistant Starch

Placebo Comparator: Elderly adults with Placebo
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.
Experimental: General adult population with MSPrebiotic
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.
Dietary Supplement: MSPrebiotic
Potato Resistant Starch
Other Name: Potato Resistant Starch

Placebo Comparator: General adult population with Placebo
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.



Primary Outcome Measures :
  1. Tolerability [ 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Changes from baseline in overall health at 2, 6, 10 and 14 weeks [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977183


Locations
Layout table for location information
Canada, Manitoba
St. Boniface Hosptial Research Centre
Winnipeg, Manitoba, Canada, R2H 2A6
Deer Lodge Centre
Winnipeg, Manitoba, Canada, R3J 0L3
Sponsors and Collaborators
St. Boniface Hospital
Deer Lodge Centre
National Microbiology Laboratory, Canada
Manitoba Starch Products
Investigators
Layout table for investigator information
Principal Investigator: Michelle J Alfa, PhD St. Boniface Hospital Research Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Michelle Alfa, Principal Investigator, St. Boniface Hospital
ClinicalTrials.gov Identifier: NCT01977183    
Other Study ID Numbers: RRC/2013/1285
B2013:016 ( Other Identifier: University of Manitoba Biomedical Reserach Ethics Board )
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: July 2015
Keywords provided by Dr. Michelle Alfa, St. Boniface Hospital:
gastrointestinal
microbiome
prebiotic
starch