Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults

Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults

The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation

Inclusion Criteria:

• Frail (as defined by the Fried frailty criteria)nonsmoking participants in the age group of 65 to 85 years old, both male and female.
• A body mass index between 18 to 35 kg/m2.
• Not on any medications/living with medical conditions that would compromise the study outcome or the safety of the research participant.
• Able to participate and willing to give written informed consent and to comply with the study restrictions.
• Willing to be assigned randomly either to the UA or the control group.

Exclusion Criteria:

Participants must not have:

• Participated in a clinical trial within 90 days of screening or more than 4 times in the previous year.
• A history (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
• A history or presence of allergy to 5-aminolevulinic acid or porphyrins.
• A history or presence of allergy to lidocaine.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
• Unwillingness or inability to refrain from consuming alcohol within 48 hours before each visit until the end of said visit.
• Unwillingness or inability to refrain from consuming 8 or more units of xanthine containing beverages and foods per day during the entire study.
• Unwillingness to not consume other mitochondrial supplements during the course of the study (such as CoQ10, reseveratrol, NR, NMN etc.) and pomegranate juice
• unwillingness to not change diet or physical activity levels during the course of the study
• Unwillingness or inability to undergo a muscle biopsy.
• Underlying chronic disease, which in the opinion of the investigator, would interfere with study participation or the validity of the measurements.
• Unintentional weight loss ≤5% of regular body weight during the last 6 months.
• Medication requirements that may interfere with the interpretation of the results.
• Loss or donation of blood over 500mL three months prior (male subjects) or four months prior (female subjects) to participating in the study.
• Smoked (tobacco and/or marijuana mixed with tobacco (THC)) within 6 months prior to the start of the study;
• Abused drugs, medicine or alcohol within up to 30 days prior to the start of the study (Alcohol: more than 10 drinks a week, with more than 2 drinks a day most days; Drugs: THC, cocaine, opiates, amphetamines/methamphetamines, benzodiazepines, barbiturates, Buprenorphine, Creatin, Methadone metabolite, oxycodone, phencyclidine);
• A positive COVID-19 test taken 1 week to 24h before study start date.