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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 26

Inclusion Criteria

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy;Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy

Secondary Outcome Measures

Name	Time	Method

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