The Influence of IgY Max on Inflammatory Markers and the Gut Microbiome

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel Dose Ranging Study on the Influence of IgY Max on Inflammatory Markers and the Gut Microbiome

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Immunoglobulin Y
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>9 maltodextrin capsules, once daily for 12 weeks | Other: Placebo<br> <br> * Other names: Maltodextrin;|
| Experimental: IgY Max Low-Dose (1g IgY Max)<br>2 Immunoglobulin Y capsules and 7 maltodextrin capsules, once daily for 12 weeks | Dietary Supplement: Immunoglobulin Y<br> <br> * Other names: IgY Max;|
| Experimental: IgY Max Mid-Dose (2g IgY Max)<br>4 Immunoglobulin Y capsules and 5 maltodextrin capsules, once daily for 12 weeks | Dietary Supplement: Immunoglobulin Y<br> <br> * Other names: IgY Max;|
| Experimental: IgY Max High-Dose (4.5g IgY Max)<br>9 Immunoglobulin Y capsules, once daily for 12 weeks | Dietary Supplement: Immunoglobulin Y<br> <br> * Other names: IgY Max;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein |  | 2 weeks and 4 weeks | 
| Gastrointestinal Symptoms | Total Gastrointestinal Quality of Life Index (GIQLI) score | 2, 4, 8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal, Microbiome, Inflammation