Evaluating the safety of a Bovine Thymus Nuclear Extract

Evaluate the Safety of a Bovine Thymus Nuclear Extract

This study is testing whether a new treatment made from bovine thymus is safe for healthy adults by comparing different doses to a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Standard Process Inc. (industry)
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT06795945 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the safety and tolerability of a Bovine Thymus Nuclear Extract in healthy adults by comparing three different dosage levels against a placebo. Participants will be randomly assigned to receive either the extract or a placebo, and neither the participants nor the researchers will know who receives which treatment. The study will last between 12 to 25 weeks, during which safety assessments and monitoring for adverse events will be conducted to ensure participant well-being.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18 to 65 with a BMI between 18.5 and 29.9.

Not a fit: Patients who are pregnant, lactating, or have allergies to bovine products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into a new supplement for enhancing immune health.

How similar studies have performed: While the approach of using thymus extracts is not widely tested, similar studies on immune health supplements have shown promising results.

Eligibility criteria

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.

Where this trial is running

Tampa, Florida

• Model Research Center — Tampa, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Bisma Sharif, MD

Conditions: Immunology, Bovine Thymus Nuclear Extract, Safety, Tolerability, Immune health