Pilot Study on the Effect of a XOS95 on the Human Gut Microbiome

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT03074019
• Lead Sponsor: Prenexus Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-08
• Primary Completion: 2017-08-31
• Study Completion: 2017-09-28
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces	8 weeks

Secondary Outcome Measures

Name	Time	Method
Effect of XOS95 on gastrointestinal bacterial counts in the feces	8 weeks
Effect of XOS95 on fasting blood glucose	4 and 8 weeks
Effect of XOS 95 on post-prandial glucose response	8 weeks	2 hour post-prandial response to a 75g oral glucose challenge
Effect of XOS on abdominal discomfort assessed by daily questionnaire	4 and 8 weeks
Effect of XOS95 on short chain fatty acid production measured in the feces	8 weeks
Effect of XOS 95 on lipid profile parameters	4 and 8 weeks	Effect of XOS 95 on lipid profile parameters (Total cholesterol, LDL-C, HDL-C and triglycerides)
Effect of XOS 95 on C-reactive protein	8 weeks
Effect of XOS on general well-being assessed by daily questionnaire	4 and 8 weeks
Effect of XOS on total Gastrointestinal Quality of Life Index (GIQLI) scores	4 and 8 weeks

Trial Locations

Locations (1)

Nutrasource Diagnostics Inc.; 🇨🇦 Guelph, Ontario, Canada