Clinical trial NCT01977183: Effects of MSPrebiotic on Gut Health in the Elderly
Official title: Effects of MSPrebiotic on Gut Health in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota
Keywords: gastrointestinal
microbiome
prebiotic
starch
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: National Microbiology Laboratory, Canada
name: MSP Starch Products Inc.
First posted: 2013-11-06
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Tolerability of 30g dose of MSPrebiotic
timeFrame: 2, 6, 10 and 14 weeks
measure: Gut health improvements
timeFrame: 2, 6, 10 and 14 weeks
measure: Levels of short chain fatty acids in stool and lipid level in blood
timeFrame: 2, 4, 6, 10 and 14 weeks
measure: Inflammatory marker
timeFrame: 2, 6, 10 and 14 weeks
Secondary outcomes:
measure: Changes from baseline in overall health at 2, 6, 10 and 14 weeks
timeFrame: 2, 6, 10 and 14 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hosptial Research Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Deer Lodge Centre
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital Research Centre
name: Michelle J Alfa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Alfa 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.
citation: Alfa 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.