Effects of Miricell Supplementation on Biomarkers of Healthy Aging and Autophagy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorNutraland USA, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Miricell™Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum Beclin-1 Concentration

Measures the change from baseline in serum Beclin-1 levels to assess autophagy activation.

Time frame
Baseline (Week 0), Week 6, and Week 12
2

Serum ULK1 Concentration

Measures the change from baseline in serum ULK-1 levels to assess autophagy activation.

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

Secondary outcomes

1

Brain-Derived Neurotrophic Factor (BDNF) Concentration

Measures the change from baseline in serum BDNF levels to evaluate indices of neuroprotection.

Time frame
Baseline (Week 0), Week 6, and Week 12
2

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.

Time frame
Baseline (Week 0), Week 6, and Week 12
3

Fasting Insulin Concentration

Measures the change from baseline in fasting insulin levels to calculate changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Time frame
Baseline (Week 0), Week 6, and Week 12
4

Cognitive Function Score via CNS Vital Signs

Evaluation of neurocognitive performance domains using the computerized CNS Vital Signs testing platform.

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

Other outcomes

1

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.

Time frame
Baseline (Week 0), Week 6, and Week 12
2

Subjective Hair and Nail Health Likert Scores

Evaluation of subjective visible signs of aging assessed via custom Likert-style questionnaires rating hair and nail appearance/quality.

Time frame
Baseline (Week 0), Week 6, and Week 12
3

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).

Time frame
Baseline (Week 0), Week 6, and Week 12
4

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.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nutraland USA, Inc.

Lead sponsor

The Center for Applied Health Sciences, LLC

Collaborator