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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Dietary supplement: Immunoglobulin Y

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 0B4
      • Nutrasource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal microbiome	As measured by microbial abundance by 16S RNA sequencing of feces	12 weeks
Stool frequency	Self-reported number of movements daily averaged over each week	12 weeks
Stool consistency	Bristol Stool Scale, self-reported per bowel movement and averaging over each week	12 weeks
Adverse events	Number of subjects with a treatment emergent adverse effect	12 weeks

Collaborators and Investigators

• Sponsor: Igy Nutrition, LLC
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2017
• Primary Completion (Actual): January 12, 2018
• Study Completion (Actual): January 12, 2018

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Microbiome; Gastrointestinal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: IGYNRPD-150001-RPD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No