An interventional study of MSPrebiotic and Placebo in Gastrointestinal Function, sponsored by Manitoba Starch Products. Completed at 1 site in Canada. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-25.
Sponsored by Manitoba Starch Products · Not applicable, Interventional, and Treatment
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.
Manitoba Starch Products is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Placebo
Dietary Supplement: MSPrebiotic
Other: Placebo
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.
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.
Changes from baseline in gut microbiome
Gut microbiome composition (ratio between number of Firmicutes and Bacteroides) will be measured using 16S ribosomal ribonucleic acid (rRNA) gene sequencing in stool samples
Time frame: 0 and 14 weeks
Changes from baseline in concentration of short chain fatty acids in stool samples
Concentration of short chain fatty acids (acetate, propionate, butyrate, isobutyrate, valerate,isovalerate) in feces will be measured using gas chromatographic method
Time frame: 0 and 14 weeks
Changes from baseline in bowel movements with respect to number of bowel movements and stool consistency
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.
Time frame: 0, 2, 6,10 and 14 weeks
Changes from baseline in blood glucose concentrations
Blood glucose levels concentrations will be measured using standard laboratory methods
Time frame: 0, 2, 6,10 and 14 weeks
Changes from baseline in blood insulin concentrations
Blood insulin concentrations will be measured using standard laboratory methods
Time frame: 0 and 14 weeks
Changes from baseline in tolerability in terms of excessive flatulence, abdominal pain, and bloating: questionnaires
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.
Time frame: 0, 2, 6,10 and 14 weeks
Changes from baseline in overall health in terms of outpatient visits and hospitalizations
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.
Time frame: 0, 2, 6,10 and 14 weeks
Changes from baseline in concentration of blood lipids and C-reactive protein Inflammatory marker C-reactive protein. Metabolomic changes
Concentration of blood lipids and C-reactive protein will be measured using standard laboratory methods.
Time frame: 0 and14 weeks
Changes from baseline in concentration of blood and fecal Metabolomics
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)
Time frame: 0 and 14 weeks
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Manitoba Starch Products