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

NCT03074019 | Completed

• 1 other identifier: PRENRPD-150002-RPD01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces

  8 weeks

Secondary Outcomes (9)

• 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

  8 weeks

• Effect of XOS 95 on lipid profile parameters

  4 and 8 weeks

Other Outcomes (1)

• Adverse events

  8 weeks

Study Arms (3)

Xylooligosaccharide (Low Dose)

EXPERIMENTAL

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

Dietary Supplement: Xylooligosaccacharide

Xylooligosaccharide (High Dose)

EXPERIMENTAL

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

Dietary Supplement: Xylooligosaccacharide

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Interventions

Xylooligosaccacharide DIETARY_SUPPLEMENT

XOS95 powder

Also known as: XOS95

Xylooligosaccharide (High Dose); Xylooligosaccharide (Low Dose)

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin powder

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prenexus Health: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Nutrasource Diagnostics Inc.

Guelph, Ontario, N1G 0B4, Canada

Location

MeSH Terms

Interventions

maltodextrin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, 3-arm, parallel, dose ranging study

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: March 1, 2017
• Primary Completion: August 31, 2017
• Study Completion: September 28, 2017
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)