Effects of MSPrebiotic on Gut Health in the Elderly

St. Boniface Hospital

Status: Completed

Conditions: Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota

Treatments: Dietary Supplement: MSPrebiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01977183

RRC/2013/1285

B2013:016 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups, including a placebo group

Elderly adults with MSPrebiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: MSPrebiotic

Elderly adults with Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

General adult population with MSPrebiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: MSPrebiotic

General adult population with Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo