The effects of Muno-IgYTM on immune function in healthy adult volunteers
- Conditions
- Prevention of cold or fluInfections and Infestations
- Registration Number
- ISRCTN51932144
- Lead Sponsor
- IGY Immune Technologies & Life Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 28
1. Healthy adult participants who are 35 to 65 years of age (inclusive).
2. Has a body mass index (BMI) between 18.5 to 29.9 kg/m² (inclusive).
3. In good general health (no uncontrolled diseases or conditions) as deemed fit by the investigator and are able to consume the study product.
4. Self-reported at least one incident of a URTI (e.g., common cold) in the last 6 months. If participants have a URTI between screening (Visit 1) and baseline (Visit 2), they must be asymptomatic by one week prior to baseline.
5. Is planning to be employed and/or attend school (minimum 20h per week) for the duration of the study period.
6. Frequent exposure to an environment that may put them at risk of contracting URTIs (i.e., health care or childcare worker, commuter using high density regular use of public transportation, and other populations that participants are regularly in public areas for the majority of their workday and use little to no personal protective equipment).
7. Appropriate for exercise as determined by the Physical Activity Readiness Questionnaire (PAR-Q).
8. Non-smokers (including nicotine vaping) and has not used nicotine-containing products for more than three months prior to baseline. Note: Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine.
9. Individuals with childbearing potential must agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of the study product and throughout the study, including:
9.1. Use for at least three months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), hormone implant (e.g., Norplant System), or intrauterine devices (e.g., Mirena); or
9.2. Use for at least one month prior to the first dose of study product: double-barrier method, non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual intercourse that can result in pregnancy; or
9.3. Vasectomy of partner at least six months prior to the first dose of study product
Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable.
10. Agree to refrain from certain restricted concomitant treatments in the respective timeframe as defined in the study protocol.
11. Has maintained consistent lifestyle, dietary (including supplement intake) and exercise habits for the last three months prior to screening and agree to maintain lifestyle, dietary and exercise habits throughout the study.
12. Agree to refrain from intense exercise for 72 h prior to Visit 2 and for 72 h prior to Visit 3 until after Visit 5.
13. Agree to avoid anal penetration for 72 h prior to fecal sample collection.
14. Able to complete study diary daily as instructed between screening and baseline.
15. Willing and able to agree to the requirements and restrictions of this study, willing to give volunta
1. Untreated lower body injury [e.g., partial anterior cruciate ligament (ACL) tear] within 6 months prior to screening and/or baseline.
2. Lactating, pregnant or planning to become pregnant during the study as confirmed at the baseline visit (Visit 2).
3. Has a known sensitivity, intolerability, or allergy to eggs or any of the study product ingredients.
4. Diagnosis or self-report of allergic rhinitis (perennial activity or seasonal allergies during seasons that will overlap with the period of the conduct of the study).
5. Currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit, or currently has any post COVID-19 condition(s) as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
6. Has received a Human Papillomavirus (HPV) or Hepatitis (A and/or B) vaccination within 4 weeks of the baseline visit (Visit 2) or any other vaccination within 2 weeks of the baseline visit (Visit 2) or plans to receive any vaccination during the period of the conduct of the study.
7. Current diagnosis or presence of lung disease [e.g., chronic obstructive pulmonary disease (COPD), pneumonia, asthma, etc.].
8. Current diagnosis or history of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn’s disease), functional constipation or diarrhea (defined by the Rome IV diagnostic criteria), celiac disease, lactose intolerance and/or malabsorption, gastroparesis, endometriosis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder, history of intestinal surgery (excluding appendectomy or herniorrhaphy), or history of bariatric surgery.
9. Has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
10. Has been diagnosed with gastroenteritis and/or has had acute GI illness such as nausea/vomiting or diarrhea within the 4 weeks prior to the baseline visit (Visit 2).
11. History or current diagnosis of arrhythmia.
12. High blood pressure (=140 systolic or =90 diastolic mmHg) as assessed at the screening and baseline visits.
13. Major surgery in three months prior to screening or planned major surgery during the course of the study.
14. Have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia etc.).
15. History of heart disease, renal or hepatic impairment/disease, uncontrolled diabetes (Type I or Type II), hepatic or renal dysfunction, unstable thyroid disease, immune disorders and/or immunocompromised (e.g., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to the screening visit, or any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential participant at risk because of participation in the study, or influences the results or the potent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immune function measured by incidence of URTI evaluated from participant diaries over a 12-week period
- Secondary Outcome Measures
Name Time Method