AutophagyNCT07675200
Effects of Miricell Supplementation on Biomarkers of Healthy Aging and Autophagy
A study testing Spermidine in people with Autophagy and Healthy Aging, run by Nutraland USA, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Autophagy, Healthy Aging
- What is being tested?
- Spermidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide voluntary signed and dated informed consent.
- Be in fair health as determined by medical history and routine blood chemistries.
- Age between the ages of 40 and 70 (inclusive).
- Body weight of at least 110 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
- Normal seated, resting heart rate (<90 per minute).
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- Willing to duplicate their previous 24-hour diet, refrain from alcohol for 24 hours, exercise for 24 hours prior to each trial, caffeine for 12 hours prior to each trial, and fast for 10 hours prior to each of the treatments.
- Participant agrees to maintain existing dietary and physical activity patterns throughout the study period.
- Participant is willing and able to comply with the study protocol.
- If a dietary supplement was initiated within the past month, the participant is willing to discontinue supplement use followed by a 2-week washout prior to participation in the study.
- Able to provide an adequate blood draw.
Who cannot join
- Use of probiotics, postbiotics or antibiotics within the past month.
- A history of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
- The participant's alcohol consumption is more than two standard alcoholic drinks per day or more than 10 drinks per week or has a history of drug/alcohol abuse or dependence.
- History of diabetes (any form) or any endocrine disorder.
- Fasting blood sugar of > 125 mg/dL.
- Current smokers who smoke 11 or more cigarettes per day (i.e. light smokers will be enrolled if they meet all other criteria).
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- History of hyperparathyroidism or an untreated thyroid disease.
- History of malignancy in the previous five years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Chronic inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's Disease, ulcerative colitis, lupus, HIV/AIDS, etc.).
- Previous medical diagnosis of gout or fibromyalgia.
- Any female who is pregnant, trying to become pregnant, is less than/or equal to 120 days postpartum, or any current women who are nursing.
- Women who participate in this study must agree to the use of contraception for the duration of the study, and any sexually active woman will have to take a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause), regardless of their use of contraception, will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
- Known allergy or sensitivity to any ingredient in the test formulations as listed on the product label.
- Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Center for Applied Health Sciences
Canfield, Ohio, 44406
Michael B La Monica, Ph.D., CSCS, 330-206-0767, ML@appliedhealthsciences.org
About this study
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:
Read more
- Does Miricell improve markers of autophagy, which is the body's natural process for recycling damaged cells?
- Does Miricell support brain health, metabolic health, and visible signs of aging?
- What medical problems, if any, do participants experience while taking Miricell?
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:
- Take either one Miricell capsule or a placebo every day for 12 weeks with a morning meal.
- Visit the research clinic four times over the course of the study for checkups and tests.
- Complete memory and thinking tests, track their daily physical activity, and give blood samples to measure health changes.
Read the detailed description
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:
- Participants receive detailed instructions to avoid altering their baseline intake of polyamine-rich foods (such as aged cheeses, fermented soy, and specific grains/mushrooms) to ensure nutritional stability.
- Dietary tracking is deployed at multiple intervals to longitudinally verify caloric and macronutrient consistency throughout the study period.
- Prior to scheduled laboratory evaluations, participants must replicate their individual 24-hour baseline diet, abstain from alcohol and heavy physical exertion for 24 hours, avoid caffeine for 12 hours, and maintain a strict 10-hour overnight fast.
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.
- Conditions
- Autophagy, Healthy Aging
- Being tested
- Spermidine, Placebo
- Keywords
- Spermidine, Polyamines, Cognitive Function, Miricell(R), Cellular Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpermidineDietary 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.
PlaceboDietary supplement
Placebo capsule (microcrystalline cellulose) packaged in an identical-looking, opaque capsule to be ingested daily with water in the morning with a meal.
| Study group | Role | What they receive |
|---|---|---|
| Miricell™ | 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. Receives: Dietary Supplement: Spermidine |
| Placebo | Placebo comparator | Participants assigned to this arm will receive one look-alike placebo capsule daily for a total duration of 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Beclin-1 Concentration
Measures the change from baseline in serum Beclin-1 levels to assess autophagy activation.
Measured: 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.
Measured: Baseline (Week 0), Week 6, and Week 12
Secondary outcomes (7)
Brain-Derived Neurotrophic Factor (BDNF) Concentration
Measures the change from baseline in serum BDNF levels to evaluate indices of neuroprotection.
Measured: Baseline (Week 0), Week 6, and Week 12
High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Measures the change from baseline in hs-CRP levels to evaluate systemic inflammatory status and cardio-metabolic health.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start9 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutophagyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutraland USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Center for Applied Health Sciences, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675200
- Sponsor's protocol ID
- NLMIRI-01-2025
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40862848
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Miricell Supplementation on Biomarkers of Healthy Aging and Autophagy
- ClinicalTrials.gov ID
- NCT07675200
- Acronym / sponsor ID
- NLMIRI-01-2025
- Conditions
- Autophagy, Healthy Aging
- Keywords
- Spermidine, Polyamines, Cognitive Function, Miricell(R), Cellular Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nutraland USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Center for Applied Health Sciences, LLC
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 Jun 2026 (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 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:
- Does Miricell improve markers of autophagy, which is the body's natural process for recycling damaged cells?
- Does Miricell support brain health, metabolic health, and visible signs of aging?
- What medical problems, if any, do participants experience while taking Miricell?
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:
- Take either one Miricell capsule or a placebo every day for 12 weeks with a morning meal.
- Visit the research clinic four times over the course of the study for checkups and tests.
- Complete memory and thinking tests, track their daily physical activity, and give blood samples to measure health changes.
Detailed description
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:
- Participants receive detailed instructions to avoid altering their baseline intake of polyamine-rich foods (such as aged cheeses, fermented soy, and specific grains/mushrooms) to ensure nutritional stability.
- Dietary tracking is deployed at multiple intervals to longitudinally verify caloric and macronutrient consistency throughout the study period.
- Prior to scheduled laboratory evaluations, participants must replicate their individual 24-hour baseline diet, abstain from alcohol and heavy physical exertion for 24 hours, avoid caffeine for 12 hours, and maintain a strict 10-hour overnight fast.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miricell™ | Active comparator | Dietary Supplement: SpermidineParticipants 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 | Dietary Supplement: PlaceboParticipants assigned to this arm will receive one look-alike placebo capsule daily for a total duration of 12 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide voluntary signed and dated informed consent.
- Be in fair health as determined by medical history and routine blood chemistries.
- Age between the ages of 40 and 70 (inclusive).
- Body weight of at least 110 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
Key exclusion criteria (14 listed)
- Use of probiotics, postbiotics or antibiotics within the past month.
- A history of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
- The participant's alcohol consumption is more than two standard alcoholic drinks per day or more than 10 drinks per week or has a history of drug/alcohol abuse or dependence.
- History of diabetes (any form) or any endocrine disorder.
- Fasting blood sugar of > 125 mg/dL.
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 |
|---|---|---|
| SpermidineBranded 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. | Dietary supplement | Miricell™ |
| PlaceboPlacebo capsule (microcrystalline cellulose) packaged in an identical-looking, opaque capsule to be ingested daily with water in the morning with a meal. | Dietary supplement | Placebo |
Primary outcome
Serum Beclin-1 Concentration
Time frame: Baseline (Week 0), Week 6, and Week 12
Measures the change from baseline in serum Beclin-1 levels to assess autophagy activation.
Serum ULK1 Concentration
Time frame: Baseline (Week 0), Week 6, and Week 12
Measures the change from baseline in serum ULK-1 levels to assess autophagy activation.
7 secondary outcomes
Brain-Derived Neurotrophic Factor (BDNF) Concentration
Time frame: Baseline (Week 0), Week 6, and Week 12
High-Sensitivity C-Reactive Protein (hs-CRP) Concentration
Time frame: Baseline (Week 0), Week 6, and Week 12
Fasting Insulin Concentration
Time frame: Baseline (Week 0), Week 6, and Week 12
Cognitive Function Score via CNS Vital Signs
Time frame: Baseline (Week 0), Week 6, and Week 12
Patient-Reported Outcomes Measurement Information System - Cognitive Function (PROMIS-CF) Score
Time frame: Baseline (Week 0), Week 6, and Week 12
Patient-Reported Outcomes Measurement Information System - Cognitive Function - Abilities (PROMIS-CF-A) Score
Time frame: Baseline (Week 0), Week 6, and Week 12
Lipid Panel Metrics
Time frame: Baseline (Week 0), Week 6, and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 40862848Bruno 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spermidine in people with Autophagy and Healthy Aging, run by Nutraland USA, 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 11 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B La Monica, Ph.D., CSCS (330-206-0767, ML@appliedhealthsciences.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Beclin-1 Concentration (time frame: Baseline (Week 0), Week 6, and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07675200, which also lists 1 linked publication.
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 30 Jun 2026.