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Completed

NCT Number: NCT01977183

Effects of MSPrebiotic on Gut Health in the Elderly

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.

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Key information

Conditions

Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deer Lodge Centre, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MSPrebiotic

Dietary Supplement

Potato Resistant Starch

Other names: Potato Resistant Starch

Placebo

Dietary Supplement

Placebo - Corn Starch

Primary outcomes

  1. Tolerability of 30g dose of MSPrebiotic

    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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

St. Boniface Hospital

Other

Collaborators

  • MSP Starch Products Inc.
  • National Microbiology Laboratory, Canada

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2013
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.