Effects of MSPrebiotic on Gut Health in the Elderly

Conditions

Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota

Keywords

gastrointestinal, microbiome, prebiotic, starch

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.

Jason Bush, Michelle J. Alfa

BMC Nutrition2020-12-0130 citations

10.1186/s40795-020-00398-9

A Randomized Placebo Controlled Clinical Trial to Determine the Impact of Digestion Resistant Starch MSPrebiotic® on Glucose, Insulin, and Insulin Resistance in Elderly and Mid-Age Adults

Michelle J. Alfa, David Strang, Paramjit S. Tappia, Nancy Olson, Pat DeGagné et al. (8 authors)

Frontiers in Medicine2018-01-2243 citations

10.3389/fmed.2017.00260

A randomized trial to determine the impact of a digestion resistant starch composition on the gut microbiome in older and mid-age adults.

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.

2017-03-31100 citations

10.1016/j.clnu.2017.03.025

Interventions

DIETARY_SUPPLEMENTMSPrebiotic

Potato Resistant Starch

DIETARY_SUPPLEMENTPlacebo

Placebo - Corn Starch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Tolerability of 30g dose of MSPrebiotic	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	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	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	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

Measure	Time frame	Description
Changes from baseline in overall health at 2, 6, 10 and 14 weeks	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.

Countries

Canada

Outcome results

None listed