What side effects are associated with this type of intervention?

Common treatments for healthy aging often include dietary supplements, physical exercise, and home-based interventions. Dietary supplements such as omega-3 fatty acids and herbal formulas can sometimes cause gastrointestinal issues, allergic reactions, or interact with other medications. Physical exercise, while generally beneficial, can lead to muscle strain or injury if not performed correctly. Home-based interventions, including mental health services or physical therapy, may have minimal side effects but require adherence to protocols to avoid ineffective outcomes. It is important to consult healthcare providers to tailor these treatments to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

FDA approvals for treatments promoting healthy aging generally focus on lifestyle interventions, dietary supplements, and medications that support overall health. Commonly approved treatments include vitamin D and calcium supplements for bone health, statins for cardiovascular health, and medications like metformin, which is being studied for its potential anti-aging effects. Additionally, the FDA has approved various vaccines and medications to prevent and manage chronic conditions prevalent in older adults, such as hypertension and diabetes. While specific treatments involving home-based sample collection for healthy aging are not detailed, the approach aligns with personalized and preventive healthcare strategies aimed at monitoring and improving health outcomes in older populations.

What other types of research exist?

Promising alternatives to home-based sample collection for healthy aging patients in 2024 include advanced wearable health monitoring devices, telemedicine platforms with integrated diagnostic tools, and next-generation sequencing technologies used in clinical settings. These options offer improved accuracy, convenience, and reliability for patient monitoring and diagnostics.

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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

Must not have

Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial

Individuals who are cognitively impaired and/or who are unable to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial involves people collecting their own medical samples at home and sending them to a lab. It aims to see if these home-collected samples can be tested accurately and how often they are rejected or fail. The study targets individuals who need to provide samples but prefer or need to do it from home.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.

Select...

I am unable to understand or sign a consent form due to cognitive issues.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Healthy Aging include dietary supplements, physical exercise, and lifestyle modifications. Dietary supplements, such as antioxidants and anti-inflammatory agents, work by reducing oxidative stress and inflammation, which are key contributors to aging and age-related diseases. Physical exercise improves cardiovascular health, muscle strength, and cognitive function by enhancing blood flow, reducing inflammation, and promoting neurogenesis. Lifestyle modifications, including a balanced diet and stress management, support overall health by optimizing metabolic functions and reducing the risk of chronic diseases. These interventions are crucial for Healthy Aging patients as they help maintain functional independence, improve quality of life, and potentially extend lifespan.

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