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| Name | Class |
|---|---|
| Source Nutraceutical, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - (Age 30-50 years) | Placebo Comparator |
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| MSPrebiotic - (Age 30-50 years) | Experimental |
| |
| Placebo - (Aged 70 years and above) | Placebo Comparator |
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| MSPrebiotic - (Aged 70 years and above) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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 | 0, 2, 6,10 and 14 weeks |
| Changes from baseline in blood insulin concentrations | Blood insulin concentrations will be measured using standard laboratory methods | 0 and 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 2, 6,10 and 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nalini Kaul, PhD | Source Nutraceutical, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hill Top Research | Winnipeg | Manitoba | R3L 2W2 | Canada |
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| 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. |
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| 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. | 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. | 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) | 0 and 14 weeks |