Overview

This trial is active, not recruiting.

Condition focus of study; impact of msprebiotic on gastrointestinal microbiota
Treatment msprebiotic
Phase phase 2
Sponsor St. Boniface General Hospital Research Centre
Collaborator Deer Lodge Centre
Start date September 2013
End date January 2016
Trial size 80 participants
Trial identifier NCT01977183, B2013:016, RRC/2013/1285

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(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.
msprebiotic Potato Resistant Starch
Potato Resistant Starch
(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.
(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.
msprebiotic Potato Resistant Starch
Potato Resistant Starch
(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.

Primary Outcomes

Measure
Tolerability
time frame: 2, 6, 10 and 14 weeks
Gut health improvements
time frame: 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
Inflammatory marker
time frame: 2, 6, 10 and 14 weeks

Secondary Outcomes

Measure
Changes from baseline in overall health at 2, 6, 10 and 14 weeks
time frame: 2, 6, 10 and 14 weeks

Eligibility Criteria

Male or female participants at least 30 years old.

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.

Additional Information

Official title Effects of MSPrebiotic on Gut Health in the Elderly
Principal investigator Michelle J Alfa, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by St. Boniface General Hospital Research Centre.