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

Launched by AMAZENTIS SA · Aug 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a supplement called Mitopure (Urolithin A) on muscle health in frail older adults aged 65 to 85. The study aims to see if taking this supplement for eight weeks can improve the quality of mitochondria, which are the energy-producing parts of cells, in the muscles of participants. Mitochondrial health is important for maintaining strength and mobility, especially as we age.

To be eligible for the study, participants need to be frail according to specific criteria, have a body mass index (BMI) between 18 and 35, and not be taking medications or have health conditions that could affect the study results. Participants will be randomly assigned to receive either the Mitopure supplement or a placebo (a harmless substance with no active ingredients) for the duration of the trial. They will need to agree to certain restrictions, like avoiding alcohol and other specific supplements. Throughout the study, participants can expect regular check-ins, and they will undergo a muscle biopsy to help measure the outcomes. This trial is currently recruiting participants, and it offers a unique opportunity to contribute to research aimed at improving the health and quality of life for older adults.

Gender

ALL

Eligibility 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.