Healthy
Conditions
Keywords
Gastrointestinal, Microbiome, Inflammation
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.
Interventions
DIETARY_SUPPLEMENTImmunoglobulin Y
OTHERPlacebo
Sponsors
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Igy Nutrition, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-reactive protein | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | 2 weeks and 4 weeks | — |
| Gastrointestinal Symptoms | 2, 4, 8 and 12 weeks | Total Gastrointestinal Quality of Life Index (GIQLI) score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intestinal microbiome | 12 weeks | As measured by microbial abundance by 16S RNA sequencing of feces |
| Adverse events | 12 weeks | Number of subjects with a treatment emergent adverse effect |
| Stool frequency | 12 weeks | Self-reported number of movements daily averaged over each week |
| Stool consistency | 12 weeks | Bristol Stool Scale, self-reported per bowel movement and averaging over each week |
Countries
Canada
Outcome results
None listed