HealthyPhase 1/2NCT02972463
The Influence of IgY Max on Inflammatory Markers and the Gut Microbiome
A Phase 1/2 study testing Immunoglobulin Y in people with Healthy, run by Igy Nutrition, LLC at 1 site in Canada.
Trial summary
The purpose of this study is to determine the optimal dose of IgY as assessed by changes in the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut microbiome as assessed by 16s RNA sequencing of fecal samples. 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?
- Immunoglobulin Y
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2017to 12 Jan 2018
- Phase
- Phase 1/2
- 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)
- Self-reported complaints of minor gastrointestinal symptoms (i.e. occasional gas, bloating, etc.)
- Non-smoker, or ex-smoker ≥6 months
- Body mass index 25.0- 34.9kg/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
- Willing to avoid alcohol consumption for 24 h prior to every clinic visit
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- 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
- 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)
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- Use of prebiotic supplements (e.g. fructans and galacto-oligosaccharides (FOS, GOS), psyllium, fiber, inulin) or probiotic supplements (i.e. live microorganisms) within 4 weeks of baseline (V2) and consumption of foods fortified with prebiotics (e.g. inulin) or probiotics within 2 weeks of baseline (V2)
- 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 disease, cardiovascular disease, pancreatic, renal, or liver disease
- Chronic diarrhea or constipation, irritable bowel syndrome, or inflammatory bowel disease
- Abdominal or gastrointestinal surgery within the previous 12 months or planned abdominal or gastrointestinal surgery 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)
- 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 Dose Ranging Study on the Influence of IgY Max on Inflammatory Markers and the Gut Microbiome
The purpose of this study is to determine the optimal dose of IgY as assessed by changes in the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut microbiome as assessed by 16s RNA sequencing of fecal samples.
- Conditions
- Healthy
- Being tested
- Immunoglobulin Y, Placebo
- Keywords
- Gastrointestinal, Microbiome, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin YDietary supplement
Also called IgY Max
PlaceboOther
Also called Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 9 maltodextrin capsules, once daily for 12 weeks Receives: Other: Placebo |
| IgY Max Low-Dose (1g IgY Max) | Experimental | 2 Immunoglobulin Y capsules and 7 maltodextrin capsules, once daily for 12 weeks Receives: Dietary Supplement: Immunoglobulin Y |
| IgY Max Mid-Dose (2g IgY Max) | Experimental | 4 Immunoglobulin Y capsules and 5 maltodextrin capsules, once daily for 12 weeks Receives: Dietary Supplement: Immunoglobulin Y |
| IgY Max High-Dose (4.5g IgY Max) | Experimental | 9 Immunoglobulin Y capsules, once daily for 12 weeks Receives: Dietary Supplement: Immunoglobulin Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
Measured: 12 weeks
Secondary outcomes (2)
C-reactive protein
Measured: 2 weeks and 4 weeks
Gastrointestinal Symptoms
Total Gastrointestinal Quality of Life Index (GIQLI) score
Measured: 2, 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start13 Jan 2017
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igy Nutrition, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972463
- Sponsor's protocol ID
- IGYNRPD-150001-RPD01
- Status last verified
- Sep 2018
- First submitted
- 18 Nov 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- 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 Dose Ranging Study on the Influence of IgY Max on Inflammatory Markers and the Gut Microbiome
- ClinicalTrials.gov ID
- NCT02972463
- Acronym / sponsor ID
- IGYNRPD-150001-RPD01
- Conditions
- Healthy
- Keywords
- Gastrointestinal, Microbiome, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Igy Nutrition, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 23 Nov 2016 (estimated)
- 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 study is to determine the optimal dose of IgY as assessed by changes in the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut microbiome as assessed by 16s RNA sequencing of fecal samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo9 maltodextrin capsules, once daily for 12 weeks |
| IgY Max Low-Dose (1g IgY Max) | Experimental | Dietary Supplement: Immunoglobulin Y2 Immunoglobulin Y capsules and 7 maltodextrin capsules, once daily for 12 weeks |
| IgY Max Mid-Dose (2g IgY Max) | Experimental | Dietary Supplement: Immunoglobulin Y4 Immunoglobulin Y capsules and 5 maltodextrin capsules, once daily for 12 weeks |
| IgY Max High-Dose (4.5g IgY Max) | Experimental | Dietary Supplement: Immunoglobulin Y9 Immunoglobulin Y capsules, once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female adults aged 18 - 60 (inclusive)
- Self-reported complaints of minor gastrointestinal symptoms (i.e. occasional gas, bloating, etc.)
- Non-smoker, or ex-smoker ≥6 months
- Body mass index 25.0- 34.9kg/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
Key exclusion criteria (23 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
- 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)
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 |
|---|---|---|
| Immunoglobulin YAlso: IgY Max | Dietary supplement | IgY Max High-Dose (4.5g IgY Max), IgY Max Low-Dose (1g IgY Max), IgY Max Mid-Dose (2g IgY Max) |
| PlaceboAlso: Maltodextrin | Other | Placebo |
Primary outcome
C-reactive protein
Time frame: 12 weeks
2 secondary outcomes
C-reactive protein
Time frame: 2 weeks and 4 weeks
Gastrointestinal Symptoms
Time frame: 2, 4, 8 and 12 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
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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 Phase 1/2 study testing Immunoglobulin Y in people with Healthy, run by Igy Nutrition, LLC 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 9 inclusion and 23 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
C-reactive protein (time frame: 12 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.