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

Inclusion Criteria:

• Frail (as defined by the Fried frailty criteria)nonsmoking participants in the agegroup 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 thestudy outcome or the safety of the research participant.

• Able to participate and willing to give written informed consent and to comply withthe 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 inthe previous year.

• A history (within 3 months of screening) of alcohol consumption exceeding 2 standarddrinks 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), orhuman immunodeficiency virus antibody (HIV Ab) at screening.

• Unwillingness or inability to refrain from consuming alcohol within 48 hours beforeeach visit until the end of said visit.

• Unwillingness or inability to refrain from consuming 8 or more units of xanthinecontaining beverages and foods per day during the entire study.

• Unwillingness to not consume other mitochondrial supplements during the course ofthe study (such as CoQ10, reseveratrol, NR, NMN etc.) and pomegranate juice

• unwillingness to not change diet or physical activity levels during the course ofthe study

• Unwillingness or inability to undergo a muscle biopsy.

• Underlying chronic disease, which in the opinion of the investigator, wouldinterfere 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 fourmonths prior (female subjects) to participating in the study.

• Smoked (tobacco and/or marijuana mixed with tobacco (THC)) within 6 months prior tothe start of the study;

• Abused drugs, medicine or alcohol within up to 30 days prior to the start of thestudy (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.