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

NCT ID: NCT03074019

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2017-09-28

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Xylooligosaccharide (Low Dose)

1.5g XOS95 + 1.5g Maltodextrin powder, taken orally mixed in water, once daily

Group Type: EXPERIMENTAL

Xylooligosaccacharide

Intervention Type: DIETARY_SUPPLEMENT

XOS95 powder

Xylooligosaccharide (High Dose)

3g XOS95 powder, taken orally mixed in water, once daily

Group Type: EXPERIMENTAL

Xylooligosaccacharide

Intervention Type: DIETARY_SUPPLEMENT

XOS95 powder

Placebo

3g maltodextrin powder, taken orally mixed in water, once daily

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin powder

Interventions

Xylooligosaccacharide

XOS95 powder

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin powder

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

XOS95

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

NETWORK

Sponsor Role: collaborator

Prenexus Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nutrasource Diagnostics Inc.

Guelph, Ontario, Canada

Countries

Canada

Other Identifiers

PRENRPD-150002-RPD01

Identifier Type: -

Identifier Source: org_study_id