Effects of Miricell Supplementation on Biomarkers of Healthy Aging and Autophagy

NCT07675200 | Recruiting

• 1 other identifier: NLMIRI-01-2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autophagy; Healthy Aging

Keywords

Spermidine; Polyamines; Cognitive Function; Miricell(R); Cellular Health

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Brain-Derived Neurotrophic Factor (BDNF) Concentration

  Baseline (Week 0), Week 6, and Week 12

• High-Sensitivity C-Reactive Protein (hs-CRP) Concentration

  Baseline (Week 0), Week 6, and Week 12

• Fasting Insulin Concentration

  Baseline (Week 0), Week 6, and Week 12

• Cognitive Function Score via CNS Vital Signs

  Baseline (Week 0), Week 6, and Week 12

• Patient-Reported Outcomes Measurement Information System - Cognitive Function (PROMIS-CF) Score

  Baseline (Week 0), Week 6, and Week 12

Other Outcomes (4)

• Phenotypic Age (PhenoAge)

  Baseline (Week 0), Week 6, and Week 12

• Subjective Hair and Nail Health Likert Scores

  Baseline (Week 0), Week 6, and Week 12

• Quality of Life Score (SF-36)

  Baseline (Week 0), Week 6, and Week 12

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

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.

Miricell™

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Nutraland USA, Inc.: lead
• The Center for Applied Health Sciences, LLC: collaborator

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40862848 BACKGROUND

MeSH Terms

Interventions

Spermidine

Intervention Hierarchy (Ancestors)

Putrescine; Biogenic Polyamines; Biogenic Amines; Amines; Organic Chemicals; Polyamines

Central Study Contacts

Michael B La Monica, Ph.D., CSCS

CONTACT

330-206-0767; ML@appliedhealthsciences.org

Study Design

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

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)