| Eligibility |
Inclusion Criteria:
1. Individual is male or premenopausal female (approximately half males and half
females), 18 to 45 years of age, inclusive.
2. Individual has a BMI of =18.50 and <30.00 kg/m2.
3. Individual is judged to be in good health based on medical history and routine
laboratory tests.
4. Individual agrees to abstain from alcohol consumption and vigorous physical activity
for at least 24 h prior to all test visits. According to the World Health Organization
(WHO), vigorous physical activity may include running, fast cycling, fast swimming, or
moving heavy objects.
5. Individual understands the study procedures, and is willing to complete them, and
signs forms documenting informed consent to participate in the study and authorization
for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
1. Individual is unwilling to avoid consumption of all dietary supplements (other than
provided study products and multivitamin/mineral/calcium supplements) within 14 days
of visit (day 0) and throughout the study period.
2. Individual is a chronic user of nicotine products.
3. Individual has a score <7 on the Vein Access Scale.
4. Individual has a positive test for illicit drugs on the urine drug screen.
5. Individual has a clinically significant medical condition that, in the opinion of the
Investigator, could interfere with the interpretation of the study results.
6. Individual has an autoimmune disorder (e.g., type 1 diabetes, rheumatoid arthritis,
Graves disease, multiple sclerosis, lupus, etc.).
7. Individual has a gastrointestinal condition that would potentially interfere with
absorption of the study product (e.g., inflammatory bowel disease, celiac disease,
history of gastric bypass surgery, chronic gastritis).
8. Individual has used medication or over-the-counter products (including herbal and
dietary supplements) that, in the opinion of the investigator, could interfere with
the absorption and metabolism of lactoferrin or affect inflammatory or immune function
markers including, but not limited to, aspirin, anti-inflammatories, antacids,
histamine 2 receptor antagonists, laxatives, stool softeners, and proton-pump
inhibitors.
9. Individual has had a weight change of ±4.5 kg (10 lbs.) in the previous 3 months.
10. Individual has extreme dietary habits (e.g., Atkins, vegan, very low carbohydrate
diet).
11. Individual has history of bariatric surgery, is currently taking a weight loss drug,
or is actively attempting to lose or gain body weight.
12. Individual has an active infection or signs/symptoms of an infection. Test visits will
be rescheduled to allow the subject to be symptom-free of any type of systemic
infection for at least five days.
13. Individual has recent use of antibiotics (within 7 days of visit 2, day 0) and
throughout the study period. The test days will be rescheduled to allow the subject to
wash out the antibiotic for at least 7 days.
14. Individual has uncontrolled hypertension (systolic blood pressure =160 mm Hg and/or
diastolic blood pressure =100 mm Hg) at screening.
15. Individual has a history of cancer in the prior 2 years, except non-melanoma skin
cancer or carcinoma in situ of the cervix.
16. Individual has an allergy or sensitivity to any components of the study products.
17. Individual has an allergy or sensitivity to yeast.
18. Individual is a female who is pregnant, planning to be pregnant during the study
period, lactating, or is of childbearing potential and is unwilling to commit to the
use of a medically approved form of contraception throughout the study period.
19. Individual has been exposed to any non-registered drug product within 30 days of the
screening visit.
20. Individual has a current or recent history (past 12 months of screening) or strong
potential for illicit drug or excessive alcohol intake defined as >14 drinks per week
(1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
21. Individual has a condition the Investigator believes would interfere with
his/her/their ability to provide informed consent, comply with the study protocol,
which might confound the interpretation of the study results or put the person at
undue risk.
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