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

NCT06795945 | Completed

• 1 other identifier: S01-24-01-T0071
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunology

Keywords

Bovine Thymus Nuclear Extract; Safety; Tolerability; Immune health

Outcome Measures

Primary Outcomes (29)

• 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 Outcomes (76)

• To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)

  12 weeks

• To assess the impact of Thymus Nuclear extract at 3 dosage levels on transcriptome

  25 weeks

• To assess the impact of Thymus Nuclear Extract at 3 dose levels on general health (sleep and cognition)

  12 weeks

Study Arms (4)

TPG1

ACTIVE COMPARATOR

Thymus Nuclear Extract Dose 1

Dietary Supplement: TPG1

TPG2

ACTIVE COMPARATOR

Thymus Nuclear Extract Dose 2

Dietary Supplement: TPG2

TPG3

ACTIVE COMPARATOR

Thymus Nuclear Extract Dose 3

Dietary Supplement: TPG3

PL

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

TPG1 DIETARY_SUPPLEMENT

* 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)

TPG1

TPG2 DIETARY_SUPPLEMENT

* 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)

TPG2

TPG3 DIETARY_SUPPLEMENT

Thymus Nuclear Extract Dose 3 (3440 mg \[8 tablets, 2x/day; total 16 tablets per day\])

TPG3

Placebo DIETARY_SUPPLEMENT

Placebo (8 tablets, 2x/day; total 16 tablets per day)

PL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants who are between 18 - 65 years of age (inclusive).
• In good general health (i.e., no uncontrolled diseases or conditions) as deemed by the investigator and are able to consume the study product.
• Have a body mass index (BMI) range of 18.5 - 29.9 kg/m2 (inclusive).
• Agree to follow the restrictions on concomitant treatments as listed.
• Agree to use acceptable contraceptive methods as listed.
• 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.
• Agree to the dosage instructions including the oral consumption of 8 tablets twice daily.

You may not qualify if:

• Individuals who are lactating, pregnant or planning to become pregnant during the study, or demonstrates a positive pregnancy test at Visit 2.
• Have a known sensitivity, intolerability, or allergy (especially to bovine products) to any of the study products or their excipients.
• 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).
• Have a chronic inflammatory condition (e.g., rheumatoid arthritis, lupus, or multiple-sclerosis).
• Have a neurological disorder which may impact cognitive testing (e.g., traumatic brain injury, epilepsy, neurodegenerative diseases).
• Have received an organ transplant or other forms of allografts or xenografts.
• Participants with sleep disorders (e.g., insomnia, sleep apnea, restless legs syndrome, narcolepsy, or any other condition that significantly affects sleep quality and duration)
• 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).
• 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).
• 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.
• Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
• Reports a clinically significant illness during the 28 days before the first dose of study product.
• Major surgery in 3 months prior to screening or planned major surgery during the study.
• 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.
• 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.

Sponsors & Collaborators

• Standard Process Inc.: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Model Research Center

Tampa, Florida, 33615, United States

Location

Study Officials

• Bassem F. El-Khodor, PHD

  Standard Process Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 28, 2025
• Study Start: February 4, 2025
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)