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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Spermidine
Dietary supplementBranded 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 supplementPlacebo capsule (microcrystalline cellulose) packaged in an identical-looking, opaque capsule to be ingested daily with water in the morning with a meal.
Treatment groups
Trial outcomes
Primary outcomes
Serum Beclin-1 Concentration
Measures the change from baseline in serum Beclin-1 levels to assess autophagy activation.
Serum ULK1 Concentration
Measures the change from baseline in serum ULK-1 levels to assess autophagy activation.
Secondary outcomes
Brain-Derived Neurotrophic Factor (BDNF) Concentration
Measures the change from baseline in serum BDNF levels to evaluate indices of neuroprotection.
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.
Fasting Insulin Concentration
Measures the change from baseline in fasting insulin levels to calculate changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Cognitive Function Score via CNS Vital Signs
Evaluation of neurocognitive performance domains using the computerized CNS Vital Signs testing platform.
Other outcomes
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.
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.
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).
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.
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