Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06012669
Other study ID # MB-2305
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2023
Est. completion date December 27, 2023

Study information

Verified date February 2024
Source Midwest Center for Metabolic and Cardiovascular Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of 28-day supplementation with high-dose human recombinant lactoferrin, low-dose human recombinant lactoferrin, and an active control product formulated with bovine lactoferrin on indicators of immunity in healthy males and females.


Description:

Samples will be retained for possible analyses such as lactoferrin absorption, distribution, metabolism, and excretion (ADME) and gut microbiota.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date December 27, 2023
Est. primary completion date December 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High dose Human Lactoferrin
Dietary Supplement and Food Ingredient
Low dose Human Lactoferrin
Dietary Supplement and Food Ingredient
Active Control Bovine Lactoferrin
Dietary Supplement and Food Ingredient

Locations

Country Name City State
United States Suncoast Research Miami Florida
United States Health Awareness Port Saint Lucie Florida

Sponsors (2)

Lead Sponsor Collaborator
Midwest Center for Metabolic and Cardiovascular Research Helaina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibodies Change from baseline in anti-lactoferrin antibodies 0, 8 weeks
Secondary Markers of Immune Function Change from baseline in markers of Immune Function (such as biomarkers of inflammation) 0, 4 weeks, 8 weeks, 12 weeks
Secondary Markers of Immune Function Change from baseline in markers of Immune Function (such as T-cell responses to lactoferrin and related peptides) 0, 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT05595980 - The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults N/A
Completed NCT04780867 - Psychological and Lifestyle Factors on Health Outcomes N/A
Active, not recruiting NCT05059639 - Exploring the Role of Almonds in Enhancing Immune Strength N/A
Recruiting NCT06067477 - Estimation of the Dietary Requirement for Vitamin D in Ethnic Groups N/A
Completed NCT05004454 - Effect of Bacillus Subtilis BS50 Supplementation on Gastrointestinal Symptoms in Healthy Adults N/A
Completed NCT04733924 - Efficacy and Tolerability of Sensoril® in Improving Immunity and Thereby Reducing Incidence of Upper Respiratory Tract Infections N/A
Completed NCT04713735 - Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections N/A