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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972463
• Other study ID #: IGYNRPD-150001-RPD01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 13, 2017
• Est. completion date: January 12, 2018

Study information

• Verified date: September 2018
• Source: Igy Nutrition, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Immunoglobulin Y

Other:
• Placebo

Locations

Country	Name	City	State
Canada	Nutrasource	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Igy Nutrition, LLC	Nutrasource Diagnostics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intestinal microbiome	As measured by microbial abundance by 16S RNA sequencing of feces	12 weeks
Other	Stool frequency	Self-reported number of movements daily averaged over each week	12 weeks
Other	Stool consistency	Bristol Stool Scale, self-reported per bowel movement and averaging over each week	12 weeks
Other	Adverse events	Number of subjects with a treatment emergent adverse effect	12 weeks
Primary	C-reactive protein		12 weeks
Secondary	C-reactive protein		2 weeks and 4 weeks
Secondary	Gastrointestinal Symptoms	Total Gastrointestinal Quality of Life Index (GIQLI) score	2, 4, 8 and 12 weeks