ImmunologyNCT06795945
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Safety of a Bovine Thymus Nuclear Extract
A study testing TPG1, TPG2 and TPG3 in people with Immunology, run by Standard Process Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunology
- What is being tested?
- TPG1, TPG2 and TPG3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- TPG1, TPG2, TPG3, Placebo
- Keywords
- Bovine Thymus Nuclear Extract, Safety, Tolerability, Immune health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPG1Dietary 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)
TPG2Dietary 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)
TPG3Dietary supplement
Thymus Nuclear Extract Dose 3 (3440 mg [8 tablets, 2x/day; total 16 tablets per day])
PlaceboDietary supplement
Placebo (8 tablets, 2x/day; total 16 tablets per day)
| Study group | Role | What they receive |
|---|---|---|
| TPG1 | Active comparator | Thymus Nuclear Extract Dose 1 Receives: Dietary Supplement: TPG1 |
| TPG2 | Active comparator | Thymus Nuclear Extract Dose 2 Receives: Dietary Supplement: TPG2 |
| TPG3 | Active comparator | Thymus Nuclear Extract Dose 3 Receives: Dietary Supplement: TPG3 |
| PL | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Heart rate (bpm)
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Blood pressure (mmHg)
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Weight (kg)
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Body mass index (kg/m2)
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels.
Whole blood hemoglobin (g/dL)
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Hematocrit (%)
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Red Blood Cell Count
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Red Cell Distribution Width
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Mean Corpuscular Volume
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Mean Corpuscular Hemoglobin
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Mean Corpuscular Hemoglobin Concentration
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
White Blood Cell Count and Differential
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Platelet Count
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Mean Platelet Volume
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Blood Urea Nitrogen
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Creatinine
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Estimated Glomerular Filtration rate
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Alkaline Phosphatase
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Bilirubin Total
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Aspartate Aminotransferase
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Alanine Aminotransferase
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Albumin
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Total Protein
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Globulin
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Fasting Glucose Serum
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Chloride
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Sodium
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Potassium
Measured: 12 weeks
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Reports of adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start4 Feb 2025
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Bassem F. El-Khodor, PHD, Study director, Standard Process Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795945
- Sponsor's protocol ID
- S01-24-01-T0071
- Status last verified
- Dec 2025
- First submitted
- 6 Jan 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety of a Bovine Thymus Nuclear Extract
- ClinicalTrials.gov ID
- NCT06795945
- Acronym / sponsor ID
- S01-24-01-T0071
- Conditions
- Immunology
- Keywords
- Bovine Thymus Nuclear Extract, Safety, Tolerability, Immune health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| TPG1 | Active comparator | Dietary Supplement: TPG1Thymus Nuclear Extract Dose 1 |
| TPG2 | Active comparator | Dietary Supplement: TPG2Thymus Nuclear Extract Dose 2 |
| TPG3 | Active comparator | Dietary Supplement: TPG3Thymus Nuclear Extract Dose 3 |
| PL | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | TPG1 |
| 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 | TPG2 |
| TPG3Thymus Nuclear Extract Dose 3 (3440 mg [8 tablets, 2x/day; total 16 tablets per day]) | Dietary supplement | TPG3 |
| PlaceboPlacebo (8 tablets, 2x/day; total 16 tablets per day) | Dietary supplement | PL |
Primary outcome
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Heart rate (bpm)
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Blood pressure (mmHg)
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Weight (kg)
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Body mass index (kg/m2)
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels.
Time frame: 12 weeks
Whole blood hemoglobin (g/dL)
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Hematocrit (%)
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Red Blood Cell Count
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Red Cell Distribution Width
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Mean Corpuscular Volume
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Mean Corpuscular Hemoglobin
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Mean Corpuscular Hemoglobin Concentration
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
White Blood Cell Count and Differential
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Platelet Count
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Mean Platelet Volume
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Blood Urea Nitrogen
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Creatinine
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Estimated Glomerular Filtration rate
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Alkaline Phosphatase
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Bilirubin Total
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Aspartate Aminotransferase
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Alanine Aminotransferase
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Albumin
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Total Protein
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Globulin
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Fasting Glucose Serum
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Chloride
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Sodium
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Potassium
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels
Time frame: 12 weeks
Reports of adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassem F. El-Khodor, PHD study director
Standard Process Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPG1, TPG2 and TPG3 in people with Immunology, run by Standard Process Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of Thymus Nuclear Extract at 3 dose levels (time frame: 12 weeks). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.