Clinical trial NCT02972463: The Influence of IgY Max on Inflammatory Markers and the Gut Microbiome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Gastrointestinal
Microbiome
Inflammation
Lead sponsor: Igy Nutrition, LLC
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2016-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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
* 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 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

Primary outcomes:
measure: C-reactive protein
timeFrame: 12 weeks
Secondary outcomes:
measure: C-reactive protein
timeFrame: 2 weeks and 4 weeks
measure: Gastrointestinal Symptoms
timeFrame: 2, 4, 8 and 12 weeks
Other outcomes:
measure: Intestinal microbiome
timeFrame: 12 weeks
measure: Stool frequency
timeFrame: 12 weeks
measure: Stool consistency
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Locations:
city: Guelph
country: Canada
facility: Nutrasource
state: Ontario
Study officials:
References: