Clinical trial NCT06795945: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Safety of a Bovine Thymus Nuclear Extract
Official title: Evaluate the Safety of a Bovine Thymus Nuclear Extract
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Immunology
Keywords: Bovine Thymus Nuclear Extract
Safety
Tolerability
Immune health
Lead sponsor: Standard Process Inc.
Sponsor class: INDUSTRY
Collaborators: name: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
First posted: 2025-01-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels.
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)
timeFrame: 12 weeks
measure: To assess the impact of Thymus Nuclear extract at 3 dosage levels on transcriptome
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)
timeFrame: 12 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)
timeFrame: 12 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 25 weeks
measure: To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 25 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 12 weeks
measure: To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers
timeFrame: 12 weeks
Locations:
city: Tampa
country: United States
facility: Model Research Center
state: Florida
Study officials:
affiliation: Standard Process Inc.
name: Bassem F. El-Khodor, PHD
role: STUDY_DIRECTOR
References: