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

Trial Summary

What is the purpose of this trial?

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.

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.

Is Mitopure + Pomegranate Juice safe for humans?

Pomegranate products, including extracts and juices, have been studied for their safety and are generally well tolerated in humans. Clinical studies have shown no major safety concerns with the doses used, although pomegranate may affect the metabolism of some synthetic drugs by activating liver enzymes. ^{1 2 3 4 5}

How does the Mitopure + Pomegranate Juice treatment differ from other treatments?

The Mitopure + Pomegranate Juice treatment is unique because it combines Mitopure, a supplement aimed at enhancing mitochondrial function, with pomegranate juice, which is rich in ellagitannins that are metabolized into urolithins with potent antioxidant properties. This combination may offer a novel approach to improving overall health by supporting cellular energy production and providing systemic antioxidant effects. ^{1 6 7 8 9}

Research Team

Anurag Singh, MD, PhD

Principal Investigator

Amazentis SA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Urolithins, intestinal microbial metabolites of Pomegranate ellagitannins, exhibit potent antioxidant activity in a cell-based assay. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Preparative isolation and purification of urolithins from the intestinal metabolites of pomegranate ellagitannins by high-speed counter-current chromatography. [2019]

3. United States 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of pomegranate medicinal products for cancer. [2020]

5. England pubmed.ncbi.nlm.nih.gov

In vivo anti-inflammatory and antioxidant properties of ellagitannin metabolite urolithin A. [2019]

6. Germany 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. [2019]

7. United States 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. [2019]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Pomegranate juice nutritional profile]. [2020]

9. Switzerland 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. [2020]