A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Safety of a Bovine Thymus Nuclear Extract

Evaluate the Safety of a Bovine Thymus Nuclear Extract

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.

Study Overview

• Status: Completed
• Conditions: Immunology
• Intervention / Treatment: Dietary supplement: TPG1; Dietary supplement: TPG2; Dietary supplement: TPG3; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33615
      • Model Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TPG1; Thymus Nuclear Extract Dose 1	Dietary supplement: TPG1; 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)
Active Comparator: TPG2; Thymus Nuclear Extract Dose 2	Dietary supplement: TPG2; 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)
Active Comparator: TPG3; Thymus Nuclear Extract Dose 3	Dietary supplement: TPG3; Thymus Nuclear Extract Dose 3 (3440 mg [8 tablets, 2x/day; total 16 tablets per day])
Placebo Comparator: PL; Placebo	Dietary supplement: Placebo; Placebo (8 tablets, 2x/day; total 16 tablets per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Heart rate (bpm)	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Blood pressure (mmHg)	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Weight (kg)	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Body mass index (kg/m2)	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels.	Whole blood hemoglobin (g/dL)	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Hematocrit (%)	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Red Blood Cell Count	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Red Cell Distribution Width	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Mean Corpuscular Volume	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Mean Corpuscular Hemoglobin	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Mean Corpuscular Hemoglobin Concentration	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	White Blood Cell Count and Differential	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Platelet Count	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Mean Platelet Volume	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Blood Urea Nitrogen	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Creatinine	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Estimated Glomerular Filtration rate	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Alkaline Phosphatase	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Bilirubin Total	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Aspartate Aminotransferase	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Alanine Aminotransferase	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Albumin	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Total Protein	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Globulin	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Fasting Glucose Serum	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Chloride	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Sodium	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Potassium	12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Reports of adverse events	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)	PROMIS Disturbance - short Form 8b score	12 weeks
To assess the impact of Thymus Nuclear extract at 3 dosage levels on transcriptome	Whole Blood Transcriptome Analysis	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)	Patient Health Questionnaire (PHQ-9) score	12 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)	Self-Administered Gerocognitive Examination (SAGE) score	12 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Adrenal hormones:dehydroepiandrosterone	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Estradiol	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Sex Hormone-Binding Globulin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Spermidine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Spermine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Putrescine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Histamine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Serotonin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Tryptamine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Tyramine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Cadaverine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Ferritin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Phosphorus	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Calcium	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Magnesium	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Vitamin D	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Vitamin B12	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Folate	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Homocysteine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IgM	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IgA	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IgG	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Rheumatoid Factor	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Anti-Citrullinated Protein Antibodies	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Collagen	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Con-Citrullinated Fibronectin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Vimentin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated GFAP	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Myelin Basic Protein	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Neuron-Specific Enolase	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated S100 Calcium-Binding Protein B	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Intracellular Adhesion Molecule	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Brain-Derived Neurotrophic Factor	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Actin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Zonulin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Myosin Heavy Chain 7	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Myoglobin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Induction of Autoantibodies Against Citrullinated and Non-Citrullinated Troponin	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Triglycerides	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Total Cholesterol	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Low-Density Lipoprotein Cholesterol	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	High-Density Lipoprotein Cholesterol	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Apolipoprotein A	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Lipoprotein A	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Apolipoprotein B	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IL-1	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IL-1 receptor antagonist protein (IL-1RN)	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IL-6	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IL-8	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IL-13	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IL-18	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IFN-alpha	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	IFN-beta	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	TGF-beta	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	TNF	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Serum Amyloid A	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Serum Tau	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Neurofilament Light	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	S100B	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	C-Reactive Protein	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	GFAP levels	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Free and Total Triiodothyronine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Free and Total Thyroxine	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Thyroid Stimulating Hormone	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Triiodothyronine Uptake Test	25 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Gama-Glutamyl Transferase	25 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels	Uric Acid	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Total Cortisol	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	C- Peptide	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Lactate dehydrogenase	25 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Corticoid-Binding Globulin	12 weeks
To assess the impact of Thymus Nuclear Extract at 3 dose levels on blood biomarkers	Free Cortisol Index	12 weeks

Collaborators and Investigators

• Sponsor: Standard Process Inc.
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Investigators: Study Director: Bassem F. El-Khodor, PHD, Standard Process Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2025
• Primary Completion (Actual): November 24, 2025
• Study Completion (Actual): November 24, 2025

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Tolerability; Immune health; Bovine Thymus Nuclear Extract
• Other Study ID Numbers: S01-24-01-T0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No