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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074019
• Other study ID #: PRENRPD-150002-RPD01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: September 28, 2017

Study information

• Verified date: September 2018
• Source: Prenexus Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 28, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Xylooligosaccacharide
XOS95 powder
• Maltodextrin
Maltodextrin powder

Locations

Country	Name	City	State
Canada	Nutrasource Diagnostics Inc.	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Prenexus Health	Nutrasource Diagnostics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Number of subjects with a treatment emergent adverse effect	8 weeks
Primary	Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces		8 weeks
Secondary	Effect of XOS95 on short chain fatty acid production measured in the feces		8 weeks
Secondary	Effect of XOS95 on gastrointestinal bacterial counts in the feces		8 weeks
Secondary	Effect of XOS95 on fasting blood glucose		4 and 8 weeks
Secondary	Effect of XOS 95 on post-prandial glucose response	2 hour post-prandial response to a 75g oral glucose challenge	8 weeks
Secondary	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
Secondary	Effect of XOS 95 on C-reactive protein		8 weeks
Secondary	Effect of XOS on abdominal discomfort assessed by daily questionnaire		4 and 8 weeks
Secondary	Effect of XOS on general well-being assessed by daily questionnaire		4 and 8 weeks
Secondary	Effect of XOS on total Gastrointestinal Quality of Life Index (GIQLI) scores		4 and 8 weeks