Mitopure + Pomegranate Juice for Healthy Subjects

Overseen By Julie Faitg, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Amazentis SA

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Blood donation, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively participants can collect samples at home while taking Mitopure (Urolithin A) and pomegranate juice. Researchers will measure the levels of Urolithin A in the blood after consumption of these products. The trial is open to generally healthy individuals aged 18 to 80 who are willing to follow study instructions and consume the trial products. As an unphased trial, participants can contribute to innovative research that may enhance health and wellness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have taken antibiotics in the last 30 days, you cannot participate.

What prior data suggests that Mitopure and Pomegranate Juice are safe for healthy subjects?

Research has shown that Mitopure, a supplement designed to support the energy centers of cells, is generally safe. In studies, participants taking Mitopure did not encounter any serious safety issues. Most maintained normal liver, kidney, and heart function, which are crucial for safety.

Some sources mention that Urolithin A, a key ingredient in Mitopure, has been tested in high doses without problems, though its long-term safety remains uncertain. However, shorter studies have not reported major issues.

For those considering joining the trial, this information suggests that Mitopure is likely safe. However, consulting a healthcare provider is always best to make informed decisions based on personal health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mitopure and pomegranate juice because they offer a natural way to boost levels of Urolithin A in the body. Unlike typical supplements or drugs, which might use synthetic compounds, Mitopure is derived directly from natural sources. Urolithin A is known for its potential to improve mitochondrial function, which could enhance cellular energy and overall health. This natural approach not only highlights the potential for fewer side effects but also taps into the body's own processes for better health outcomes.

What evidence suggests that Mitopure and Pomegranate Juice could be effective for healthy subjects?

Research shows that Mitopure, which contains Urolithin A, can greatly improve muscle strength and endurance. In one study, participants experienced about a 12% increase in muscle strength. Urolithin A also supports mitochondrial health, crucial for energy production in cells. Another study found that Mitopure was safe and well-tolerated by participants. In this trial, participants will undergo a Mitopure challenge to assess blood levels of Urolithin A after consuming pomegranate juice and Mitopure supplements. Pomegranate juice, which naturally contains Urolithin A, is often compared to Mitopure to evaluate the body's ability to utilize it. These findings suggest that both Mitopure and pomegranate juice may enhance muscle function and overall health. ^{6 7 8 9 10}

Who Is on the Research Team?

Anurag Singh, MD, PhD

Principal Investigator

Amazentis SA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to take the study drug, fill out questionnaires, and complete the study.

Have given voluntary, electronic, informed consent to be a participant in the study

Is in general good health, as determined by the research team

Exclusion Criteria

Subjects with unstable medical conditions

Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume Pomegranate juice followed by Mitopure supplementation to assess blood levels of Urolithin A

4 weeks

Virtual home-based participation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mitopure
• Pomegranate Juice

Trial Overview 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.

How Is the Trial Designed?

Group I: Mitopure Challenge to assess blood levels of Urolithin A after dietary and Mitopure intake Experimental Treatment 2 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)

Who Is Running the Clinical Trial?

Amazentis SA

Lead Sponsor

Trials

21

Recruited

1,400+

Published Research Related to This Trial

Pomegranate juice is rich in over 30 nutrients, including significant amounts of polyphenolic compounds like ellagitannins, anthocyanins, and minerals such as potassium, magnesium, and copper, which contribute to its health benefits.

The juice has high antioxidant activity and a notable acidity level, with organic acids like citric and L-malic acids being predominant, making it a nutritious option for enhancing dietary intake of micronutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pomegranate juice nutritional profile]. Khomich, LM., Perova, IB., Eller, KI.[2020]

Pomegranate juice demonstrated neuroprotective effects in a rat model of Parkinson's disease, improving postural stability and enhancing neuronal survival while reducing oxidative damage and α-synuclein aggregation.

The protective effects of pomegranate juice are likely mediated by its metabolites, particularly urolithin A, which was found to distribute to the brain, suggesting a potential mechanism for its benefits in neurodegenerative conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective Effects of Pomegranate Juice against Parkinson's Disease and Presence of Ellagitannins-Derived Metabolite-Urolithin A-In the Brain. Kujawska, M., Jourdes, M., Kurpik, M., et al.[2020]

In a study of 70 men taking pomegranate extract (POMx) before prostate surgery, there was a 16% reduction in oxidative stress biomarker 8-OHdG in benign tissue, although this result was not statistically significant.

POMx was well tolerated with no treatment-related withdrawals, and it successfully led to the accumulation of urolithin A, a pomegranate metabolite, in prostate tissues, indicating potential biological activity that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, neoadjuvant study of the tissue effects of POMx pills in men with prostate cancer before radical prostatectomy. Freedland, SJ., Carducci, M., Kroeger, N., et al.[2021]

Urolithins A and B were successfully isolated from pomegranate metabolites using advanced chromatography techniques, yielding high-purity compounds (over 98.5%).

These urolithins demonstrated a protective effect against oxidative stress in colon cancer cells by reducing harmful reactive oxygen species (ROS) and malondialdehyde levels, while increasing superoxide dismutase (SOD) activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparative isolation and purification of urolithins from the intestinal metabolites of pomegranate ellagitannins by high-speed counter-current chromatography. Zhao, W., Wang, Y., Hao, W., et al.[2019]

Clinical studies on pomegranate products for cancer treatment showed poor evidence of effectiveness due to low-quality research, despite promising preclinical results in cancer cell lines and animal models.

While pomegranate preparations are generally safe at the doses used in studies, they may pose risks by increasing liver enzyme activity, which could affect the metabolism of other drugs, highlighting the need for careful regulation and labeling of these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of pomegranate medicinal products for cancer. Vlachojannis, C., Zimmermann, BF., Chrubasik-Hausmann, S.[2020]

Pomegranate extracts, especially from the flowers (POMf), significantly reduced atherosclerotic lesions in mice by up to 70% and improved serum lipid and glucose levels, indicating strong antiatherogenic properties.

All pomegranate parts exhibited antioxidative effects, with POMf and other extracts enhancing macrophage function by decreasing oxidized-LDL uptake and increasing protective enzyme activity, suggesting a mechanism for their cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pomegranate phenolics from the peels, arils, and flowers are antiatherogenic: studies in vivo in atherosclerotic apolipoprotein e-deficient (E 0) mice and in vitro in cultured macrophages and lipoproteins. Aviram, M., Volkova, N., Coleman, R., et al.[2019]

Urolithin A, a metabolite from pomegranate consumption, significantly reduced paw swelling in mice within 1 hour of oral administration, indicating its potential as an anti-inflammatory agent.

The study found a strong correlation between increased plasma levels of urolithin A and enhanced antioxidant capacity, suggesting that it may help protect against inflammatory diseases through its antioxidant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo anti-inflammatory and antioxidant properties of ellagitannin metabolite urolithin A. Ishimoto, H., Shibata, M., Myojin, Y., et al.[2019]

In a study involving six healthy participants who consumed 1 liter of pomegranate juice daily for 5 days, the ellagitannin punicalagin and ellagic acid were not detected in plasma or urine, indicating low bioavailability of these compounds in humans.

Instead, three microbial metabolites derived from ellagitannins were found in the plasma and urine, but these metabolites did not exhibit significant antioxidant activity compared to punicalagin, suggesting that the health benefits of pomegranate juice may be linked to these metabolites rather than the original polyphenols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potent in vitro antioxidant ellagitannins from pomegranate juice are metabolised into bioavailable but poor antioxidant hydroxy-6H-dibenzopyran-6-one derivatives by the colonic microflora of healthy humans. Cerdá, B., Espín, JC., Parra, S., et al.[2019]

Urolithins, which are metabolites of pomegranate ellagitannins produced by gut bacteria, exhibit strong antioxidant properties, with urolithins C and D being the most effective, showing significantly lower IC(50) values compared to their parent compounds, ellagic acid and punicalagins.

The study highlights that the antioxidant activity of urolithins is influenced by their chemical structure, particularly the number of hydroxy groups and lipophilicity, suggesting that these metabolites may play a key role in the systemic antioxidant effects of pomegranate products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urolithins, intestinal microbial metabolites of Pomegranate ellagitannins, exhibit potent antioxidant activity in a cell-based assay. Bialonska, D., Kasimsetty, SG., Khan, SI., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9133463/

Urolithin A improves muscle strength, exercise ... The data show significant improvements in muscle strength (∼12%) with intake of Urolithin A. We observe clinically meaningful improvements with ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2788244

Effect of Urolithin A Supplementation on Muscle Endurance ... These findings indicate that urolithin A was safe and well tolerated as well as beneficial for muscle endurance and mitochondrial health in older adults.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04160312

Mitopure™ (Proprietary Urolithin A) Bioavailability in ... This study evaluates Mitopure™ (Urolithin A) bioavailability in healthy adults, comparing it to pomegranate juice in a single-center, two-period, crossover, ...

4. timeline.com timeline.com/studies?srsltid=AfmBOoqNJ9Fh3LzOZ-lRpfOzjR2OG_rYgZvaH-2lJmzJGP547HsJny5j

Research | Studies on Mitopure® Urolithin A - Timeline Urolithin A improves muscle strength, exercise performance, and biomarkers of mitochondrial health in a randomized trial in middle-aged adults.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35584623/

Urolithin A improves muscle strength, exercise ... The data show significant improvements in muscle strength (∼12%) with intake of Urolithin A.

6. droracle.ai droracle.ai/articles/238974/is-there-any-potential-adverse-effects-of-taking-mitopure-and-c150

Potential Adverse Effects of Taking Mitopure and C15:0 Based on current evidence, there are no documented significant adverse effects specifically associated with Mitopure (a mitochondrial supplement) ...

7. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/22607m.pdf

Safety Data Sheet Information on toxicological effects. · Acute toxicity: · Primary irritant effect: · on the skin: Irritant to skin and mucous membranes. · on ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278691517304325

Safety assessment of Urolithin A, a metabolite produced by ... There were no adverse effects observed in the 28- and 90-day oral studies. •. The NOAEL was the highest dose tested in the 90-day oral study: 3451 and 3826 mg/ ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10609777/

Pharmacological Effects of Urolithin A and Its Role in ... Additionally, most studies have relatively short periods, and the long-term effects and safety of Urolithin A usage have not been adequately evaluated.

10. omre.co omre.co/blogs/news/urolithin-a-side-effects?srsltid=AfmBOor-6CSJV9WujWKotXLxdoitdMCKVr7IoWjOlhTN6k3uSwRBWNvn

Urolithin A Side Effects: Is It Really Safe to Take? In human studies, Urolithin A has been well tolerated with no serious safety concerns. Most participants showed normal liver, kidney, and heart ...