Immunology
Conditions
Keywords
Bovine Thymus Nuclear Extract, Safety, Tolerability, Immune health
Brief summary
The goal of this trial is to find out if Thymus Nuclear Extract is safe and well-tolerated in healthy men and women by testing three different dose levels and comparing the results to a placebo.
Detailed description
This is a 12 to 25 week study (if study participants are willing to follow up on study results) where participants are randomly assigned to groups and neither they nor the researchers know who receives Thymus Nuclear Extract or a placebo. The trial focuses on evaluating the safety of the extract in healthy adults by monitoring for adverse events and conducting safety assessments throughout the study.
Interventions
DIETARY_SUPPLEMENTTPG1
* Thymus Nuclear Extract Dose 1 (860 mg \[2 tablets, 2x/day; total 4 tablets per day\]) * Placebo (6 tablets, 2x/day; total 12 tablets per day)
DIETARY_SUPPLEMENTTPG2
* Thymus Nuclear Extract Dose 2 (2150 mg \[5 tablets, 2x/day; total 10 tablets per day\]) * Placebo (3 tablets, 2x/day; total 6 tablets per day)
DIETARY_SUPPLEMENTTPG3
Thymus Nuclear Extract Dose 3 (3440 mg \[8 tablets, 2x/day; total 16 tablets per day\])
DIETARY_SUPPLEMENTPlacebo
Placebo (8 tablets, 2x/day; total 16 tablets per day)
Sponsors
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Standard Process Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
The study includes four groups: three test product groups and one placebo group (PL), all consisting of healthy male and female adults aged 18 to 65 (inclusive). Each participant's involvement in the study will last up to 25 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female participants who are between 18 - 65 years of age (inclusive). 2. In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator and are able to consume the study product. 3. Have a body mass index (BMI) range of 18.5 - 29.9 kg/m2 (inclusive). 4. Agree to follow the restrictions on concomitant treatments as listed. 5. Agree to use acceptable contraceptive methods as listed. 6. Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures. 7. Agree to the dosage instructions including the oral consumption of 8 tablets twice daily.
Exclusion criteria
1. Individuals who are lactating, pregnant or planning to become pregnant during the study, or demonstrates a positive pregnancy test at Visit 2. 2. Have a known sensitivity, intolerability, or allergy (especially to bovine products) to any of the study products or their excipients. 3. Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease (uncontrolled defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions). 4. Have a chronic inflammatory condition (e.g., rheumatoid arthritis, lupus, or multiple-sclerosis). 5. Have a neurological disorder which may impact cognitive testing (e.g., traumatic brain injury, epilepsy, neurodegenerative diseases). 6. Have received an organ transplant or other forms of allografts or xenografts. 7. Participants with sleep disorders (e.g., insomnia, sleep apnea, restless legs syndrome, narcolepsy, or any other condition that significantly affects sleep quality and duration) 8. Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency). 9. Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS). 10. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit. 11. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.). 12. Reports a clinically significant illness during the 28 days before the first dose of study product. 13. Major surgery in 3 months prior to screening or planned major surgery during the study. 14. Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study. 15. Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study. 16. Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels | 12 weeks | Heart rate (bpm) |
| To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels. | 12 weeks | Whole blood hemoglobin (g/dL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition) | 12 weeks | PROMIS Disturbance - short Form 8b score |
| To assess the impact of Thymus Nuclear extract at 3 dosage levels on transcriptome | 25 weeks | Whole Blood Transcriptome Analysis |
| To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers | 25 weeks | Adrenal hormones:dehydroepiandrosterone |
| To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels | 25 weeks | Gama-Glutamyl Transferase |
Countries
United States
Outcome results
None listed