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

Igy Nutrition

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Dietary Supplement: Immunoglobulin Y

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02972463

IGYNRPD-150001-RPD01

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

9 maltodextrin capsules, once daily for 12 weeks

Treatment:

Other: Placebo

IgY Max Low-Dose (1g IgY Max)

Experimental group

Description:

2 Immunoglobulin Y capsules and 7 maltodextrin capsules, once daily for 12 weeks

Treatment:

Dietary Supplement: Immunoglobulin Y

IgY Max Mid-Dose (2g IgY Max)

Experimental group

Description:

4 Immunoglobulin Y capsules and 5 maltodextrin capsules, once daily for 12 weeks

Treatment:

Dietary Supplement: Immunoglobulin Y

IgY Max High-Dose (4.5g IgY Max)

Experimental group

Description:

9 Immunoglobulin Y capsules, once daily for 12 weeks

Treatment:

Dietary Supplement: Immunoglobulin Y