COMPLETED

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

Conditions

Immunology Bovine Thymus Nuclear Extract Safety Tolerability Immune health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluate the Safety of a Bovine Thymus Nuclear Extract

Quick Facts

Study Start:2025-02-04

Study Completion:2025-11-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06795945

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Bassem F. El-Khodor, PHD

STUDY_DIRECTOR

Standard Process Inc.

Study Locations (Sites)

Model Research Center

Tampa, Florida, 33615

United States

Collaborators and Investigators

Sponsor: Standard Process Inc.

Bassem F. El-Khodor, PHD, STUDY_DIRECTOR, Standard Process Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-04

Study Completion Date2025-11-24

Study Record Updates

Study Start Date2025-02-04

Study Completion Date2025-11-24

Terms related to this study

Keywords Provided by Researchers

Bovine Thymus Nuclear Extract
Safety
Tolerability
Immune health

Additional Relevant MeSH Terms

Immunology