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Completed

NCT Number: NCT03910153

Effect of MSPrebiotic on Gastrointestinal Function and Blood Glucose Levels

The objective of the study is to investigate the impact of daily consumption of MSPrebiotic at a dosage level of 30 g per day for 12 weeks on gastrointestinal microbiota in the elderly (> 70 years age) and another age group (30 to 50 years). In addition, impact of MSPrebiotic on short chain fatty acids, glucose and insulin levels as well as metabolomic changes will also be studied. A randomized, double-blinded study will be conducted to assess the health benefits of MSPrebiotic and compared with a placebo. This study will provide substantiation for a beneficial effect of MSPrebiotic resistant starch on gut microbiome.

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Key information

Conditions

Gastrointestinal Function

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hill Top Research

Winnipeg, Manitoba, R3L 2W2, Canada

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 (or by the authorized 3rd party).
  • Willing to provide stool (2 times) and blood (6 times) samples over the 14 week study period
  • Subjects between 30-50 and above 70 years of age
  • Subjects willing to provide fasting blood during Screening and weeks 0, 2, 6, 10 and 14 visits
  • Female subjects not pregnant or breast feeding
  • Female subjects not planning for pregnancy during the study period

Exclusion criteria

  • 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 (e.g. yoghurt),
  • 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.
  • Subjects allergic to potato or corn
  • Have conditions, factors, medication (other than those listed above) that the Investigator believes may affect the response of the gut or the interpretation of the test results

Treatment and study plan

MSPrebiotic

Dietary Supplement

MSPrebiotic digestion resistant starch from potatoes (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the potato resistant starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.

Placebo

Other

Corn starch (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the corn starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.

Primary outcomes

  1. Changes from baseline in gut microbiome

    Time frame: 0 and 14 weeks

    Gut microbiome composition (ratio between number of Firmicutes and Bacteroides) will be measured using 16S ribosomal ribonucleic acid (rRNA) gene sequencing in stool samples

  2. Changes from baseline in concentration of short chain fatty acids in stool samples

    Time frame: 0 and 14 weeks

    Concentration of short chain fatty acids (acetate, propionate, butyrate, isobutyrate, valerate,isovalerate) in feces will be measured using gas chromatographic method

  3. Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency

    Time frame: 0, 2, 6,10 and 14 weeks

    Number of bowel movements will be measured using questionnaire. Stool consistency will be measured using questionnaires recording Bristol score. Bristol stool chart indicates the following types: Type 1-Separate hard lumps, like nuts; Type 2-Sausage-shaped but lumpy; Type 3-Like a sausage but with cracks on its surface; Type 4-Like a sausage or snake, smooth and soft; Type 5-Soft blobs with clear-cut edges (passed easily); Type 6-Fluffy pieces with ragged edges, a mushy stool; Type 7-Watery, no solid pieces. Entirely liquid.

  4. Changes from baseline in blood glucose concentrations

    Time frame: 0, 2, 6,10 and 14 weeks

    Blood glucose levels concentrations will be measured using standard laboratory methods

  5. Changes from baseline in blood insulin concentrations

    Time frame: 0 and 14 weeks

    Blood insulin concentrations will be measured using standard laboratory methods

Secondary outcomes

  1. Changes from baseline in tolerability in terms of excessive flatulence, abdominal pain, and bloating: questionnaires

    Time frame: 0, 2, 6,10 and 14 weeks

    Tolerability of consuming MSPrebiotic in terms of excessive flatulence, abdominal pain, and bloating will be measured using questionnaires. The questionnaire will record the severity of flatulence, abdominal pain and bloating on a scale of 1 to 5 where 1=none and 5=extreme.

  2. Changes from baseline in overall health in terms of outpatient visits and hospitalizations

    Time frame: 0, 2, 6,10 and 14 weeks

    Overall health will be measured using questionnaires on outpatient visits and hospitalizations. The questionnaire contains Yes/No question to record if the subject had any outpatient visits or hospitalizations.

  3. Changes from baseline in concentration of blood lipids and C-reactive protein Inflammatory marker C-reactive protein. Metabolomic changes

    Time frame: 0 and14 weeks

    Concentration of blood lipids and C-reactive protein will be measured using standard laboratory methods.

  4. Changes from baseline in concentration of blood and fecal Metabolomics

    Time frame: 0 and 14 weeks

    Concentration of blood and fecal metabolomics will be measured using reverse phase liquid chromatography quadrupole time of flight tandem mass spectroscopy (RPLC-QTOF-MS/MS)

Sponsors and collaborators

Lead sponsor

MSP Starch Products Inc.

Industry

Collaborators

  • Source Nutraceutical, Inc.

Registry information

Official study title

Effect of MSPrebiotic Digestion Resistant Starch on Gastrointestinal Function and Blood Glucose Levels

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2019
Registry last updated
Jan 25, 2022

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.

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