Trial | NCT03910153  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    110
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.
Study Started
Apr 08
2019
Primary Completion
Oct 07
2019
Study Completion
Oct 07
2019
Last Update
Jan 25
2022

Dietary Supplement MSPrebiotic

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.

Other Placebo

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.

Placebo - (Age 30-50 years) Placebo Comparator

MSPrebiotic - (Age 30-50 years) Experimental

Placebo - (Aged 70 years and above) Placebo Comparator

MSPrebiotic - (Aged 70 years and above) Experimental

Criteria 

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
No Results Posted