NCT06795945

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Standard Process Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Immunology

Interventions

Type	Name	Description
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)
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)
DIETARY_SUPPLEMENT	TPG3	Thymus Nuclear Extract Dose 3 (3440 mg \[8 tablets, 2x/day; total 16 tablets per day\])
DIETARY_SUPPLEMENT	Placebo	Placebo (8 tablets, 2x/day; total 16 tablets per day)

Timeline

• Start date: 2025-02-04
• Primary completion: 2025-11-24
• Completion: 2025-11-24
• First posted: 2025-01-28
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States