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| Name | Class |
|---|---|
| The Center for Applied Health Sciences, LLC | INDUSTRY |
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The goal of this clinical trial is to learn if a dietary supplement called Miricell works to improve cellular health and signs of healthy aging in adults. It will also learn about the safety of Miricell.
The main questions it aims to answer are:
Researchers will compare Miricell to a placebo (a look-alike capsule that contains no active ingredients) to see if Miricell works better to support healthy aging.
Participants will:
This randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluates the physiological impacts of a standardized spermidine ingredient (Miricell®) over a 12-week intervention period.
Participants are randomized in a 1:1 ratio into one of two parallel groups. To ensure rigorous double-blind conditions, investigators, research site staff, and participants remain masked to group allocations throughout the duration of the trial. Investigational products are supplied in identical-looking, opaque capsules packaged in coded bottles to prevent accidental unblinding. The randomization schedule is maintained securely and will only be broken in the event of a medical emergency requiring immediate knowledge of the treatment assignment.
To minimize confounding variables related to endogenous autophagy activation and variable background polyamine intake, strict lifestyle compliance measures are enforced across both groups:
Participant safety is continuously monitored by the investigative medical staff. All local or systemic adverse events are systematically evaluated and categorized by clinical severity. Internal data monitoring and quality assurance reviews are performed regularly by designated site staff to guarantee protocol adherence and regulatory compliance. Backup blood samples are kept from each visit to protect against any laboratory or processing errors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miricellâ„¢ | Active Comparator | Participants assigned to this arm will receive one capsule of the active branded spermidine supplement (Miricell) daily for a total duration of 12 weeks. |
|
| Placebo | Placebo Comparator | Participants assigned to this arm will receive one look-alike placebo capsule daily for a total duration of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spermidine | Dietary Supplement | Branded spermidine ingredient (Miricell® Rice Germ Extract) administered orally at a dose of 3.3 mg/day. Provided as a single opaque capsule to be ingested daily with water in the morning with a meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Beclin-1 Concentration | Measures the change from baseline in serum Beclin-1 levels to assess autophagy activation. | Baseline (Week 0), Week 6, and Week 12 |
| Serum ULK1 Concentration | Measures the change from baseline in serum ULK-1 levels to assess autophagy activation. | Baseline (Week 0), Week 6, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Brain-Derived Neurotrophic Factor (BDNF) Concentration | Measures the change from baseline in serum BDNF levels to evaluate indices of neuroprotection. | Baseline (Week 0), Week 6, and Week 12 |
| High-Sensitivity C-Reactive Protein (hs-CRP) Concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Phenotypic Age (PhenoAge) | An assessment of biological age calculated using a validated multi-variable algorithm incorporating chronological age alongside specific clinical biomarkers from the complete blood count (CBC), comprehensive metabolic panel (CMP), and hs-CRP. | Baseline (Week 0), Week 6, and Week 12 |
| Subjective Hair and Nail Health Likert Scores |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B La Monica, Ph.D., CSCS | Contact | 330-206-0767 | ML@appliedhealthsciences.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Recruiting | Canfield | Ohio | 44406 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40862848 | Background | Bruno G, La Monica M, Ziegenfuss TN. Effects of Spermidine-Rich Rice Germ Extract Supplement on Biomarkers of Healthy Aging and Autophagy-Proof-of-Concept Pilot Study. Altern Ther Health Med. 2025 Oct;31(6):9-13. |
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| ID | Term |
|---|---|
| D013095 | Spermidine |
| ID | Term |
|---|---|
| D011700 | Putrescine |
| D015317 | Biogenic Polyamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
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| Placebo | Dietary Supplement | Placebo capsule (microcrystalline cellulose) packaged in an identical-looking, opaque capsule to be ingested daily with water in the morning with a meal. |
|
Measures the change from baseline in hs-CRP levels to evaluate systemic inflammatory status and cardio-metabolic health.
| Baseline (Week 0), Week 6, and Week 12 |
| Fasting Insulin Concentration | Measures the change from baseline in fasting insulin levels to calculate changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Baseline (Week 0), Week 6, and Week 12 |
| Cognitive Function Score via CNS Vital Signs | Evaluation of neurocognitive performance domains using the computerized CNS Vital Signs testing platform. | Baseline (Week 0), Week 6, and Week 12 |
| Patient-Reported Outcomes Measurement Information System - Cognitive Function (PROMIS-CF) Score | Participant-reported evaluation of cognitive capabilities utilizing the standardized PROMIS-CF Short Form 8a questionnaire | Baseline (Week 0), Week 6, and Week 12 |
| Patient-Reported Outcomes Measurement Information System - Cognitive Function - Abilities (PROMIS-CF-A) Score | Participant-reported evaluation of cognitive abilities utilizing the standardized PROMIS-CF-A Short Form 8a questionnaire. | Baseline (Week 0), Week 6, and Week 12 |
| Lipid Panel Metrics | Standard clinical panel measuring fasting serum cholesterol fractions (Total, LDL, HDL) and triglycerides to evaluate lipid homeostasis. | Baseline (Week 0), Week 6, and Week 12 |
Evaluation of subjective visible signs of aging assessed via custom Likert-style questionnaires rating hair and nail appearance/quality. |
| Baseline (Week 0), Week 6, and Week 12 |
| Quality of Life Score (SF-36) | Evaluation of general health-related quality of life metrics using the standardized 36-Item Short Form Survey (SF-36). | Baseline (Week 0), Week 6, and Week 12 |
| Body Composition via Bioelectrical Impedance Analysis (BIA) | Assessment of shifts in fat mass and fat-free mass using an InBody 570 analyzer to track physiological changes over time. | Baseline (Week 0), Week 6, and Week 12 |
| D009930 |
| Organic Chemicals |
| D011073 | Polyamines |