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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPG1 | Active Comparator | Thymus Nuclear Extract Dose 1 |
|
| TPG2 | Active Comparator | Thymus Nuclear Extract Dose 2 |
|
| TPG3 | Active Comparator | Thymus Nuclear Extract Dose 3 |
|
| PL | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPG1 | Dietary Supplement |
|
|
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bassem F. El-Khodor, PHD | Standard Process Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Model Research Center | Tampa | Florida | 33615 | United States |
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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.
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| TPG2 | Dietary Supplement |
|
|
| TPG3 | Dietary Supplement | Thymus Nuclear Extract Dose 3 (3440 mg [8 tablets, 2x/day; total 16 tablets per day]) |
|
| Placebo | Dietary Supplement | Placebo (8 tablets, 2x/day; total 16 tablets per day) |
|
| 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 |
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 |