HealthyNOURISHNCT04160312
Mitopure™ (Proprietary Urolithin A) Bioavailability in Healthy Adults
A study testing Mitopure™ (Proprietary Urolithin A) and Pomegranate Juice in people with Healthy and Healthy Aging, run by Amazentis SA at 1 site in United States.
Trial summary
This is a single-center, two-period, crossover, randomized, open labelled study enrolling 100 healthy subjects to evaluate the Urolithin A producer status and to compare bioavailabilty of direct dietary supplementation with Mitopure™ (proprietary Urolithin A) to dietary exposure with pomegranate juice Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Aging
- What is being tested?
- Mitopure™ (Proprietary Urolithin A) and Pomegranate Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 18 to 80 years of age;
- Is in general good health, as determined by the clinical research team;
- Willingness to consume investigational product, complete questionnaires and to complete all clinic visits;
- Have given voluntary, written, informed consent to participant in the study;
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
- Alcohol or drug abuse within the last 6 months;
- Volunteers who plan to donate blood during the study or within 30 days of completing the study;
- Subject has a known allergy to the test material's active or inactive ingredients;
- Subjects with unstable medical conditions;
- Clinically significant abnormal laboratory results at screening;
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- Participation in a clinical research trial within 30 days prior to randomization;
- Allergy or sensitivity to study ingredients; lactose intolerance.
- Individuals who are cognitively impaired and/or who are unable to give informed consent;
- 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.
- Has taken antibiotics within the previous 30 days;
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantia Food Clinical Trials CRO (Northwestern University campus)
Chicago, Illinois, 60611
About this study
Official title: Open-labelled, Crossover and Randomized Study With Mitopure™ (Proprietary Urolithin A) Dietary Supplementation Compared to Pomegranate Juice Intake: A Bioavailability Study in Healthy Adults (NOURISH)
This is a single-center, two-period, crossover, randomized, open labelled study enrolling 100 healthy subjects to evaluate the Urolithin A producer status and to compare bioavailabilty of direct dietary supplementation with Mitopure™ (proprietary Urolithin A) to dietary exposure with pomegranate juice
- Conditions
- Healthy, Healthy Aging
- Being tested
- Mitopure™ (Proprietary Urolithin A), Pomegranate Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitopure™ (Proprietary Urolithin A)Dietary supplement
Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
Pomegranate JuiceDietary supplement
100% Pomegranate juice (approximately 1 glass equivalent)
| Study group | Role | What they receive |
|---|---|---|
| Mitopure™ (Proprietary Urolithin A) | Experimental | Fruit flavored food sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A) Receives: Dietary Supplement: Mitopure™ (Proprietary Urolithin A) |
| Pomegranate Juice | Experimental | 100% Pomegranate juice equivalent to a glass of juice Receives: Dietary Supplement: Pomegranate Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from T0 to T+24 hours in the Urolithin A (UA) group as compared to Pomegranate Juice (PJ) group in UA- glucuronide plasma levels.
Measured: 2 days
Secondary outcomes (17)
Absolute change from T0 to T+24 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels
Measured: 2 days
Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide plasma levels.
Measured: 1 day
Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels.
Measured: 1 day
Change in AUC from T0 to T+6 and/or T+24 in the UA group as compared to the PJ group in UA glucuronide levels
Measured: 2 days
Absolute change from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA aglycone (parent) plasma levels
Measured: 2 days
Change in AUC from T0 to T+6 and/or T+24 in the UA group as compared to the PJ group in UA aglycone (parent) plasma levels
Measured: 2 days
Absolute change from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA sulfate plasma levels
Measured: 2 days
Change in AUC from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA sulfate plasma levels
Measured: 2 days
To assess prevalence of UA producers following consumption of fixed volume of Pomegranate juice in a healthy US population
Measured: 2 days
Differences between UA producers and non-producers at baseline for Hand grip strength using a calibrated JAMAR® Hydraulic Hand Dynamometer
Measured: 2 days
Differences between UA producers and non-producers at baseline for gait speed using the 4-meter gait speed test
Measured: 2 days
Differences between UA producers and non-producers at baseline for physical activity levels assessed via the International Physical Activity Questionnaire.
Questionnaire consists of questions that provide information on the physical activity in the last 7 days. Activities include total of duration and frequency from walking, moderate activity and severe physical activity. Accordingly,there are 3 activity levels: Inactive,minimal active and very active.The lowest level of physical activity is inactive and the highest level of physical activity is very active.
Measured: 2 days
Differences between UA producers and non-producers at baseline for energy levels assessed via the Lee-Visual Analogue Scale to assess Fatigue (VAS-F).
The scale consists of 18 items relating to the subjective experience of fatigue. Scores fall between 0 (not fatigued at all) and 100 (extremely fatigued).
Measured: 2 days
Differences between UA producers and non-producers at baseline for gut microbiome. Fecal samples will be used to extract DNA and shotgun sequencing will be performed to assess global microbiome differences at the species level.
Measured: 2 days
Differences between UA producers and non-producers at baseline for plasma metabolome. Metabolites in serum will be measured by metabolomic mass spectrometry
Measured: 2 days
Differences between UA producers and non-producers at baseline for blood biochemistry metabolic profile as assessed via lipid profile in plasma.
Measured: 2 days
Differences in consumer perception on the study investigation food products overall taste using a consumer perception Likert scale
Scale, of 1 to 5 where 1 is dislike extremely and 5 is like extremely
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start8 Nov 2019
- Primary completion29 Feb 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Ali Keshavarzian, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160312
- Sponsor's protocol ID
- AFCRO-110 / 19.01.AMZ
- Acronym
- NOURISH
- Status last verified
- Apr 2020
- First submitted
- 5 Nov 2019
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labelled, Crossover and Randomized Study With Mitopure™ (Proprietary Urolithin A) Dietary Supplementation Compared to Pomegranate Juice Intake: A Bioavailability Study in Healthy Adults (NOURISH)
- ClinicalTrials.gov ID
- NCT04160312
- Acronym / sponsor ID
- NOURISH / AFCRO-110 / 19.01.AMZ
- Conditions
- Healthy, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, two-period, crossover, randomized, open labelled study enrolling 100 healthy subjects to evaluate the Urolithin A producer status and to compare bioavailabilty of direct dietary supplementation with Mitopure™ (proprietary Urolithin A) to dietary exposure with pomegranate juice
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitopure™ (Proprietary Urolithin A) | Experimental | Dietary Supplement: Mitopure™ (Proprietary Urolithin A)Fruit flavored food sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A) |
| Pomegranate Juice | Experimental | Dietary Supplement: Pomegranate Juice100% Pomegranate juice equivalent to a glass of juice |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females 18 to 80 years of age;
- Is in general good health, as determined by the clinical research team;
- Willingness to consume investigational product, complete questionnaires and to complete all clinic visits;
- Have given voluntary, written, informed consent to participant in the study;
Key exclusion criteria (11 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial;
- Alcohol or drug abuse within the last 6 months;
- Volunteers who plan to donate blood during the study or within 30 days of completing the study;
- Subject has a known allergy to the test material's active or inactive ingredients;
- Subjects with unstable medical conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitopure™ (Proprietary Urolithin A)Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A) | Dietary supplement | Mitopure™ (Proprietary Urolithin A) |
| Pomegranate Juice100% Pomegranate juice (approximately 1 glass equivalent) | Dietary supplement | Pomegranate Juice |
Primary outcome
Absolute change from T0 to T+24 hours in the Urolithin A (UA) group as compared to Pomegranate Juice (PJ) group in UA- glucuronide plasma levels.
Time frame: 2 days
17 secondary outcomes
Absolute change from T0 to T+24 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels
Time frame: 2 days
Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide plasma levels.
Time frame: 1 day
Absolute change from T0 to T+6 hours in the UA group as compared to PJ group in UA- glucuronide blood spot levels.
Time frame: 1 day
Change in AUC from T0 to T+6 and/or T+24 in the UA group as compared to the PJ group in UA glucuronide levels
Time frame: 2 days
Absolute change from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA aglycone (parent) plasma levels
Time frame: 2 days
Change in AUC from T0 to T+6 and/or T+24 in the UA group as compared to the PJ group in UA aglycone (parent) plasma levels
Time frame: 2 days
Absolute change from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA sulfate plasma levels
Time frame: 2 days
Change in AUC from T0 to T6 hours and/or to T24 hours in the UA group as compared to PJ group in UA sulfate plasma levels
Time frame: 2 days
To assess prevalence of UA producers following consumption of fixed volume of Pomegranate juice in a healthy US population
Time frame: 2 days
Differences between UA producers and non-producers at baseline for Hand grip strength using a calibrated JAMAR® Hydraulic Hand Dynamometer
Time frame: 2 days
Differences between UA producers and non-producers at baseline for gait speed using the 4-meter gait speed test
Time frame: 2 days
Differences between UA producers and non-producers at baseline for physical activity levels assessed via the International Physical Activity Questionnaire.
Time frame: 2 days
Differences between UA producers and non-producers at baseline for energy levels assessed via the Lee-Visual Analogue Scale to assess Fatigue (VAS-F).
Time frame: 2 days
Differences between UA producers and non-producers at baseline for gut microbiome. Fecal samples will be used to extract DNA and shotgun sequencing will be performed to assess global microbiome differences at the species level.
Time frame: 2 days
Differences between UA producers and non-producers at baseline for plasma metabolome. Metabolites in serum will be measured by metabolomic mass spectrometry
Time frame: 2 days
Differences between UA producers and non-producers at baseline for blood biochemistry metabolic profile as assessed via lipid profile in plasma.
Time frame: 2 days
Differences in consumer perception on the study investigation food products overall taste using a consumer perception Likert scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Keshavarzian, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitopure™ (Proprietary Urolithin A) and Pomegranate Juice in people with Healthy and Healthy Aging, run by Amazentis SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from T0 to T+24 hours in the Urolithin A (UA) group as compared to Pomegranate Juice (PJ) group in UA- glucuronide plasma levels. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.