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Mitopure + Pomegranate Juice for Healthy Subjects

N/A

Recruiting

Led By Anurag Singh, MD, PhD

Research Sponsored by Amazentis SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial assesses how well people can collect their own samples at home for testing, and how often those tests fail or are rejected.

Who is the study for?

This trial is for men and women aged 18 to 80 who are in good health and willing to consume Mitopure or pomegranate juice, complete questionnaires, and provide blood samples at home. It's not for pregnant or breastfeeding women, recent blood donors, those in other trials within the last month, people with unstable medical conditions or allergies to study ingredients.Check my eligibility

What is being tested?

The study tests how well participants can collect their own dried blood spots at home after consuming Mitopure (a supplement) or pomegranate juice. The goal is to measure levels of Urolithin A—a compound linked with healthy aging—in these samples.See study design

What are the potential side effects?

Since this trial involves generally recognized as safe substances—Mitopure and pomegranate juice—the side effects might be minimal but could include digestive discomfort or allergic reactions if sensitivity to ingredients exists.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Failure/rejection rate (% of the samples) collected at home by participants.

Secondary outcome measures

Fold change increase in the levels of UA-Glucuronide (in ng/mL) in the dried blood spots provided in the kit before and after the challenge

Sensitivity and specificity (% of the samples) of the analytical method developed to test Urolithin A in dry blood spots.

Validation of a health questionnaire on participants health status

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intakeExperimental Treatment2 Interventions

Mitopure challenge with diet (Pomegranate juice- Before) followed by Mitopure supplementation (After) to compare levels in blood spots of UA-Glucuronide (in ng/mL)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitopure

2016

Completed Phase 1

~170

Pomegranate Juice

2014

Completed Phase 2

~730

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Amazentis SALead Sponsor

16 Previous Clinical Trials

899 Total Patients Enrolled

2 Trials studying Healthy Aging

190 Patients Enrolled for Healthy Aging

Anurag Singh, MD, PhDPrincipal InvestigatorAmazentis SA

2 Previous Clinical Trials

134 Total Patients Enrolled

Media Library

Mitopure Clinical Trial Eligibility Overview. Trial Name: NCT04985630 — N/A

Healthy Aging Clinical Trial 2023: Mitopure Highlights & Side Effects. Trial Name: NCT04985630 — N/A

Healthy Aging Research Study Groups: Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake

Mitopure 2023 Treatment Timeline for Medical Study. Trial Name: NCT04985630 — N/A

Healthy Aging Patient Testimony for trial: Trial Name: NCT04985630 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to enroll in this research?

"This medical trial requires 250 participants with healthy aging, aged 18 to 80. These volunteers must be willing to consume the investigational product, complete questionnaires and the study itself; have given their electronic consent for participation in this research project; fit within the age range of 18-80 years old ; and possess general good health as determined by researchers."

Answered by AI

How many participants are conducting this research effort?

"Affirmative. The clinicaltrials.gov website indicates that this medical investigation is still recruiting individuals - it was first posted on August 30th 2021 and the most recent update was June 29th 2022. 250 patients will be accepted at a single site for this trial."

Answered by AI

Is enrollment available for seniors aged 85 and above in this experiment?

"Patients aged 18 to 80 may be considered for this clinical trial, while 64 and 452 trials are available respectively for minors and seniors."

Answered by AI

Are there remaining spots available for participants of this research program?

"This medical trial is actively looking for participants according to its listing on clinicaltrials.gov; the study was first posted on August 30th 2021 and most recently edited June 29th 2022."

Answered by AI