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

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Pilot Study on the Effect of a Novel Prebiotic, XOS95, on the Human Gut Microbiome

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Xylooligosaccacharide; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 0B4
      • Nutrasource Diagnostics Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Xylooligosaccharide (Low Dose); 1.5g XOS95 + 1.5g Maltodextrin powder, taken orally mixed in water, once daily	Dietary supplement: Xylooligosaccacharide; XOS95 powder; Other Names: XOS95
EXPERIMENTAL: Xylooligosaccharide (High Dose); 3g XOS95 powder, taken orally mixed in water, once daily	Dietary supplement: Xylooligosaccacharide; XOS95 powder; Other Names: XOS95
PLACEBO_COMPARATOR: Placebo; 3g maltodextrin powder, taken orally mixed in water, once daily	Dietary supplement: Maltodextrin; Maltodextrin powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of XOS95 on short chain fatty acid production measured in the feces		8 weeks
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	2 hour post-prandial response to a 75g oral glucose challenge	8 weeks
Effect of XOS 95 on lipid profile parameters	Effect of XOS 95 on lipid profile parameters (Total cholesterol, LDL-C, HDL-C and triglycerides)	4 and 8 weeks
Effect of XOS 95 on C-reactive protein		8 weeks
Effect of XOS on abdominal discomfort assessed by daily questionnaire		4 and 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of subjects with a treatment emergent adverse effect	8 weeks

Collaborators and Investigators

• Sponsor: Prenexus Health
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): August 31, 2017
• Study Completion (ACTUAL): September 28, 2017

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (ACTUAL): March 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PRENRPD-150002-RPD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No