HealthyNCT03074019
Pilot Study on the Effect of a XOS95 on the Human Gut Microbiome
A study testing Xylooligosaccacharide and Maltodextrin in people with Healthy, run by Prenexus Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Xylooligosaccacharide and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Xylooligosaccacharide, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylooligosaccacharideDietary supplement
Also called XOS95
XOS95 powder
MaltodextrinDietary supplement
Maltodextrin powder
| Study group | Role | What they receive |
|---|---|---|
| Xylooligosaccharide (Low Dose) | Experimental | 1.5g XOS95 + 1.5g Maltodextrin powder, taken orally mixed in water, once daily Receives: Dietary Supplement: Xylooligosaccacharide |
| Xylooligosaccharide (High Dose) | Experimental | 3g XOS95 powder, taken orally mixed in water, once daily Receives: Dietary Supplement: Xylooligosaccacharide |
| Placebo | Placebo comparator | 3g maltodextrin powder, taken orally mixed in water, once daily Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces
Measured: 8 weeks
Secondary outcomes (9)
Effect of XOS95 on short chain fatty acid production measured in the feces
Measured: 8 weeks
Effect of XOS95 on gastrointestinal bacterial counts in the feces
Measured: 8 weeks
Effect of XOS95 on fasting blood glucose
Measured: 4 and 8 weeks
Effect of XOS 95 on post-prandial glucose response
2 hour post-prandial response to a 75g oral glucose challenge
Measured: 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)
Measured: 4 and 8 weeks
Effect of XOS 95 on C-reactive protein
Measured: 8 weeks
Effect of XOS on abdominal discomfort assessed by daily questionnaire
Measured: 4 and 8 weeks
Effect of XOS on general well-being assessed by daily questionnaire
Measured: 4 and 8 weeks
Effect of XOS on total Gastrointestinal Quality of Life Index (GIQLI) scores
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Aug 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, 3-arm, parallel, dose ranging study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prenexus Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074019
- Sponsor's protocol ID
- PRENRPD-150002-RPD01
- Status last verified
- Sep 2018
- First submitted
- 3 Mar 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03074019
- Acronym / sponsor ID
- PRENRPD-150002-RPD01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Prenexus HealthIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, placebo-controlled, 3-arm, parallel, dose ranging study
| Arm | Type | Receives |
|---|---|---|
| Xylooligosaccharide (Low Dose) | Experimental | Dietary Supplement: Xylooligosaccacharide1.5g XOS95 + 1.5g Maltodextrin powder, taken orally mixed in water, once daily |
| Xylooligosaccharide (High Dose) | Experimental | Dietary Supplement: Xylooligosaccacharide3g XOS95 powder, taken orally mixed in water, once daily |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin3g maltodextrin powder, taken orally mixed in water, once daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (27 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XylooligosaccacharideAlso: XOS95XOS95 powder | Dietary supplement | Xylooligosaccharide (High Dose), Xylooligosaccharide (Low Dose) |
| MaltodextrinMaltodextrin powder | Dietary supplement | Placebo |
Primary outcome
Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces
Time frame: 8 weeks
9 secondary outcomes
Effect of XOS95 on short chain fatty acid production measured in the feces
Time frame: 8 weeks
Effect of XOS95 on gastrointestinal bacterial counts in the feces
Time frame: 8 weeks
Effect of XOS95 on fasting blood glucose
Time frame: 4 and 8 weeks
Effect of XOS 95 on post-prandial glucose response
Time frame: 8 weeks
Effect of XOS 95 on lipid profile parameters
Time frame: 4 and 8 weeks
Effect of XOS 95 on C-reactive protein
Time frame: 8 weeks
Effect of XOS on abdominal discomfort assessed by daily questionnaire
Time frame: 4 and 8 weeks
Effect of XOS on general well-being assessed by daily questionnaire
Time frame: 4 and 8 weeks
Effect of XOS on total Gastrointestinal Quality of Life Index (GIQLI) scores
Time frame: 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylooligosaccacharide and Maltodextrin in people with Healthy, run by Prenexus Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of XOS95 on abundance of microbial populations by 16S RNA sequencing of feces (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.