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

Amazentis

Status

Enrolling

Conditions

Muscle Atrophy

Aging

Frailty

Sarcopenia

Treatments

Dietary Supplement: Mitopure (Urolithin A)

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06556706

2024-10182

Details and patient eligibility

About

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

Enrollment

26 estimated patients

Sex

All

Ages

65 to 85 years old

Volunteers

No Healthy Volunteers

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.