Effects of MSPrebiotic on Gut Health in the Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of MSPrebiotic on Gut Health in the Elderly

Conditions
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Focus of Study; Impact of MSPrebiotic on Gastrointestinal Microbiota

Intervention / Treatment
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* Dietary Supplement: MSPrebiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly adults with MSPrebiotic<br>30 g of MSPrebiotic (potato resistant starch) per day taken with 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi-solid food. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. | Dietary Supplement: MSPrebiotic<br>* Potato Resistant Starch<br>* Other names: Potato Resistant Starch;|
| Placebo Comparator: Elderly adults with Placebo<br>30 g of corn starch per day taken with 1 glass (approximately 250 mL) of non-heated fluid or or non-heated semi-solid food. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. | Dietary Supplement: Placebo<br>* Placebo - Corn Starch<br>|
| Experimental: General adult population with MSPrebiotic<br>30 g of MSPrebiotic (potato resistant starch) per day taken with 1 glass (approximately 250 mL) of non-heated fluid. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. | Dietary Supplement: MSPrebiotic<br>* Potato Resistant Starch<br>* Other names: Potato Resistant Starch;|
| Placebo Comparator: General adult population with Placebo<br>30 g of corn starch per day taken with 1 glass (approximately 250 mL) of non-heated fluid. If the participant is taking any medications, they will be advised to either take the product 2 hours before or 2 hours after any medications. | Dietary Supplement: Placebo<br>* Placebo - Corn Starch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of 30g dose of MSPrebiotic | 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, 6, 10 and 14 weeks | 
| Gut health improvements | 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. | 2, 6, 10 and 14 weeks | 
| Levels of short chain fatty acids in stool and lipid level in blood | 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. | 2, 4, 6, 10 and 14 weeks | 
| Inflammatory marker | Changes from baseline of Inflammatory marker (IL-10, C-reactive protein, TNFα) levels in blood at 2, 6, 10 and 14 weeks. | 2, 6, 10 and 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in overall health at 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. | 2, 6, 10 and 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal, microbiome, prebiotic, starch