Clinical trial NCT03074019: Pilot Study on the Effect of a XOS95 on the Human Gut Microbiome
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Pilot Study on the Effect of a Novel Prebiotic, XOS95, on the Human Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Prenexus Health
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2017-03-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, 3-arm, parallel, dose ranging study
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to assess the efficacy of a novel prebiotic, XOS95, at two different dosages, in comparison to a placebo by assessing shifts in microbial populations after 8 weeks of supplementation, assessed as changes in abundance of microbial populations.


Eligibility criteria: Inclusion Criteria:

* Male or female adults aged 18 - 60 (inclusive)
* Healthy as determined from medical history
* Non-smoker, or ex-smoker ≥6 months
* Body mass index 18.5 - 27.5kg/m2 (inclusive)
* Female subjects of childbearing potential \[i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)\] must have negative urine pregnancy test and must be using an effective birth control method , defined as:

  * Continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry , or
  * Use of an intra-uterine device or implantable contraceptive, or
  * Use of double barrier methods of birth control, or
  * Abstinence from heterosexual intercourse
* Willing to avoid alcohol consumption for 24 h prior to every clinic visit
* Willing to maintain their regimens of medications and supplements known to alter GI function (including, but not limited to, iron supplements, calcium, and anti-depressants)
* Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed
* Willing and able to provide informed written consent

Exclusion Criteria:

* Pregnancy or lactation, or subject unwilling to take appropriate contraceptives for the duration of the study
* Use of prescription non-steroidal anti-inflammatory drugs (or daily use of over the counter non-steroidal anti-inflammatory drugs \>1month), steroids, corticosteroids, or any other prescription anti-inflammatory drugs within 3 months prior to visit 1
* Individuals taking any over the counter or prescription medications, including natural health products, that may alter lipid profiles including, but not limited to fish oil (omega-3 fatty acids), statins, fibrates, bile acid exchanger resin, phytosterols, niacin or its analogues, carnitine, polyglucosamines (Chitosan) or other lipid-binding ingredients within the 3 months prior to visit 1
* Individuals taking any over the counter or prescription medications, including natural health products that may alter blood glucose (e.g. biguanides (Metformin), Alpha-lipoic Acid (ALA), Gymnema sylvestre) or insulin modulating medications (e.g. sulfonylureas, meglitinides, D-phenylalanine derivatives, thiazolidinediones, DPP-4 inhibitors, alpha-glucosidase inhibitors, bile acid sequestrants within 3 months prior to visit 1
* Use of proton pump inhibitors or medications which inhibit peristaltic movement (e.g. opioids, loperamide)
* Unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1
* Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 3 months prior to visit
* Use of over the counter or prescription laxatives or stool softeners within 1 month prior to baseline (V2)
* Use of antibiotics (other than topical) within 2 months prior to baseline (V2)
* Use of prebiotic or fiber supplements (e.g. fructans and galacto-oligosaccharides (FOS, GOS), psyllium, fiber, inulin, glucomannan, acacia fiber/gum) or probiotic supplements (i.e. live microorganisms) within 4 weeks of baseline (V2)
* Consumption of specific functional prebiotic- or probiotic-rich foods within 4 weeks of baseline (V2) (Appendix 3)
* History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
* Individuals with achlorhydria
* Presence of major diseases such as diabetes, gastrointestinal, endocrine, cardiovascular, pancreatic, renal, or liver disease
* Chronic diarrhea or constipation, irritable bowel syndrome, celiac disease, gluten-sensitive enteropathy, or inflammatory bowel disease
* Abdominal or gastrointestinal surgery within the previous 12 months or planned abdominal or gastrointestinal surgery or procedures such as colonoscopy in the next 4 months
* Recent gastrointestinal food-borne illness (within 1 month prior to visit 1)
* History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.)
* History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years
* Uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
* Abnormal laboratory test results of clinical significance, including, but not limited to ALT or AST ≥1.5X the upper limit of normal at screening (visit 1)
* Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of \>2 standard alcoholic drinks per day
* Extreme dietary habits (e.g. vegan or very low carbohydrate diets, gluten-free diet, low FODMAP diet)
* Subject has a known allergy or intolerance to the test products or placebo
* Subject is unwilling or unable to abide by the requirements of the protocol
* Any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk
* Subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit

Primary outcomes:
measure: Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of XOS95 on short chain fatty acid production measured in the feces
timeFrame: 8 weeks
measure: Effect of XOS95 on gastrointestinal bacterial counts in the feces
timeFrame: 8 weeks
measure: Effect of XOS95 on fasting blood glucose
timeFrame: 4 and 8 weeks
measure: Effect of XOS 95 on post-prandial glucose response
timeFrame: 8 weeks
measure: Effect of XOS 95 on lipid profile parameters
timeFrame: 4 and 8 weeks
measure: Effect of XOS 95 on C-reactive protein
timeFrame: 8 weeks
measure: Effect of XOS on abdominal discomfort assessed by daily questionnaire
timeFrame: 4 and 8 weeks
measure: Effect of XOS on general well-being assessed by daily questionnaire
timeFrame: 4 and 8 weeks
measure: Effect of XOS on total Gastrointestinal Quality of Life Index (GIQLI) scores
timeFrame: 4 and 8 weeks
Other outcomes:
measure: Adverse events
timeFrame: 8 weeks
Locations:
city: Guelph
country: Canada
facility: Nutrasource Diagnostics Inc.
state: Ontario
Study officials:
References: