Healthy VolunteersPhase 2NCT01950221
Pomegranate Extract and Memory
A Phase 2 study testing POMx in people with Healthy Volunteers, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This project is designed to study whether pomegranate extract benefits cognitive abilities in middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of two treatment groups: either a placebo or the pomegranate extract supplement. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- POMx
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2015
- Phase
- Phase 2
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreement to participate in the 12-month double-blind, placebo-controlled clinical trial of pomegranate extract.
- Nondemented subjects either those with normal cognition or with Mild Cognitive Impairment will be included.
- Age 50 to 75 years.
- No significant cerebrovascular disease: modified Ischemic Score of < 4
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Screening laboratory tests and EKG without significant abnormalities that might interfere with the study. If screening laboratory tests or EKG show abnormalities, subject must obtain written clearance from primary care physician before continuing in the study.
Who cannot join
- Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal) (McKhann et al, 1984). Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of stroke, Transient Ischemic Attack (TIA), carotid bruits, or lacunes on MRI scans will be excluded. Determination of dementia will be based on the clinical evaluation including assessment of functional abilities, and cognitive screening.
- Contraindication to the MRI including claustrophobia, metal in body, surgery within 60 days, certain implants or previous abnormal MRI results.
- Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale (Fahn et al, 1987).
- History of myocardial infarction within the previous year, or unstable cardiac disease.
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100).
- History of significant liver disease, clinically-significant pulmonary disease, or diabetes.
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- Current diagnosis of any major psychiatric disorder
- Current diagnosis or history of alcoholism or substance addiction.
- Regular use of any medication that may affect cognitive functioning including: centrally active beta-blockers, narcotics, Clonidine, anti-Parkinsonian medications, antipsychotics, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or Warfarin.
- Occasional use of anxiety or sleeping medications known to cause cognitive dulling will be allowed, but discouraged: chloral hydrate, non-benzodiazepine hypnotics such as: Ambien (Zolpidem) and Lunesta; or benzodiazepines such as Ativan (Lorazepam), Xanax (Alprazolam), Klonopin (Clonazepam), and Restoril (Temazepam).
- Use of any of the following medications: Amitriptyline, Amiodarone, Desipramine, Fenofibrate, Flecainide, Fluconazole, Fluoxetine, Fluvastatin, Fluvoxamine, Isoniazid, Lovastatin, Ondansetron, Phenylbutazone, Probenecid, Sertraline, Sulfamethoxazole, Sulfaphenazole, Teniposide, Voriconazole, Warfarin, and Zafirlukast
- Use of cognitive enhancing supplements (e.g. Ginkgo biloba).
- Use of any supplement containing pomegranate or pomegranate juice.
- Use of any investigational drugs within the previous month or longer, depending on drug half-life.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Longevity Center
Los Angeles, California, 90095
About this study
Official title: 12-Month, Double-blind, Placebo-Controlled Study of Pomegranate Extract
This project is designed to study whether pomegranate extract benefits cognitive abilities in middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of two treatment groups: either a placebo or the pomegranate extract supplement. Both the placebo and pomegranate extract will be packaged in 1000 milligram capsules to maintain blindness. Subjects will take one 1000 milligram capsule daily for twelve months.
The investigators expect the people receiving the pomegranate extract supplement to show better cognitive performance compared with those receiving a placebo after one, six, and twelve months. The investigators believe cognitive decline and treatment response will vary according to a genetic risk for Alzheimer's.
Read more
The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints.
Subsequently, subjects will undergo the first memory (or neuropsychological) assessments. Following the first assessment, subjects will begin taking the supplement (either the pomegranate extract or the placebo). Subjects will undergo a brief memory test at one-month mark. At six months, subjects will have a second, full neuropsychological assessment. The final assessment will take place at the end of the study, the 12-month mark. Additional blood will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if outcomes are positive. Subjects will also be asked to come to the University of California, Los Angeles (UCLA) at 3 and 9 months for supplement refills.
In total, subjects will be expected to come to UCLA for 7 visits during the course of 12-13 months.
- Conditions
- Healthy Volunteers
- Being tested
- POMx, Placebo
- Keywords
- Double-blind Trial, Placebo-controlled, Pomegranate, Memory, Memory Impairment, Cognition, Ages 50-75
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POMxDietary supplement
"POMx" is a 1,000 milligram capsule of natural pomegranate polyphenol extract.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| POMx | Experimental | POMx is a 1,000 milligram capsule of natural pomegranate polyphenol extract. Receives: Dietary Supplement: POMx |
| Placebo | Placebo comparator | Composition of the Drug Placebo Component/Function/Weight/Percentage of Fill Weight = Cellulose/Bulk agent/658 mg/64.5% Caramel/Colorant/79mg/7.8% Beet root/Flavor Ingredient/263mg/25.8% Magnesium stearate/USP Lubricant/10mg/1.0% Silica Dioxide/FCC Glidant/10mg/1.0% Total = 1020 mg/100% The method of manufacture of the placebo is identical to that of the drug product, except cellulose, caramel, and beet root are added in place of the active ingredient. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved cognitive performance
Non-demented volunteers aged 50-75 who receive a daily dietary supplement of pomegranate extract will show improved cognitive performance compared to baseline versus those receiving a placebo after one, six, and twelve months.
Measured: 1 year
Secondary outcomes (1)
Cognitive performance improvement and genotype
Cognitive change in the pomegranate intervention group will vary according to genotype.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startOct 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- POM Wonderful LLC
- Responsible party
- Principal investigator, Gary Small, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950221
- Sponsor's protocol ID
- 11-002413
- Status last verified
- Feb 2020
- First submitted
- 16 Sep 2013
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-Month, Double-blind, Placebo-Controlled Study of Pomegranate Extract
- ClinicalTrials.gov ID
- NCT01950221
- Acronym / sponsor ID
- 11-002413
- Conditions
- Healthy Volunteers
- Keywords
- Double-blind Trial, Placebo-controlled, Pomegranate, Memory, Memory Impairment, Cognition, Ages 50-75
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- POM Wonderful LLC
- Study start
- Oct 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Sep 2013 (estimated)
- 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 project is designed to study whether pomegranate extract benefits cognitive abilities in middle-aged and older non-demented volunteers. Subjects will be randomly assigned to one of two treatment groups: either a placebo or the pomegranate extract supplement. Both the placebo and pomegranate extract will be packaged in 1000 milligram capsules to maintain blindness. Subjects will take one 1000 milligram capsule daily for twelve months.
The investigators expect the people receiving the pomegranate extract supplement to show better cognitive performance compared with those receiving a placebo after one, six, and twelve months. The investigators believe cognitive decline and treatment response will vary according to a genetic risk for Alzheimer's.
The investigators will study 212 non-demented subjects aged 50-75 years. Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints.
Subsequently, subjects will undergo the first memory (or neuropsychological) assessments. Following the first assessment, subjects will begin taking the supplement (either the pomegranate extract or the placebo). Subjects will undergo a brief memory test at one-month mark. At six months, subjects will have a second, full neuropsychological assessment. The final assessment will take place at the end of the study, the 12-month mark. Additional blood will be drawn at baseline and at 12 months and frozen to assess inflammatory markers if outcomes are positive. Subjects will also be asked to come to the University of California, Los Angeles (UCLA) at 3 and 9 months for supplement refills.
In total, subjects will be expected to come to UCLA for 7 visits during the course of 12-13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POMx | Experimental | Dietary Supplement: POMxPOMx is a 1,000 milligram capsule of natural pomegranate polyphenol extract. |
| Placebo | Placebo comparator | Other: PlaceboComposition of the Drug Placebo Component/Function/Weight/Percentage of Fill Weight = Cellulose/Bulk agent/658 mg/64.5% Caramel/Colorant/79mg/7.8% Beet root/Flavor Ingredient/263mg/25.8% Magnesium stearate/USP Lubricant/10mg/1.0% Silica Dioxide/FCC Glidant/10mg/1.0% Total = 1020 mg/100% The method of manufacture of the placebo is identical to that of the drug product, except cellulose, caramel, and beet root are added in place of the active ingredient. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agreement to participate in the 12-month double-blind, placebo-controlled clinical trial of pomegranate extract.
- Nondemented subjects either those with normal cognition or with Mild Cognitive Impairment will be included.
- Age 50 to 75 years.
- No significant cerebrovascular disease: modified Ischemic Score of < 4
- Adequate visual and auditory acuity to allow neuropsychological testing.
Key exclusion criteria (15 listed)
- Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal) (McKhann et al, 1984). Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of stroke, Transient Ischemic Attack (TIA), carotid bruits, or lacunes on MRI scans will be excluded. Determination of dementia will be based on the clinical evaluation including assessment of functional abilities, and cognitive screening.
- Contraindication to the MRI including claustrophobia, metal in body, surgery within 60 days, certain implants or previous abnormal MRI results.
- Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale (Fahn et al, 1987).
- History of myocardial infarction within the previous year, or unstable cardiac disease.
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100).
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 |
|---|---|---|
| POMx"POMx" is a 1,000 milligram capsule of natural pomegranate polyphenol extract. | Dietary supplement | POMx |
| Placebo | Other | Placebo |
Primary outcome
Improved cognitive performance
Time frame: 1 year
Non-demented volunteers aged 50-75 who receive a daily dietary supplement of pomegranate extract will show improved cognitive performance compared to baseline versus those receiving a placebo after one, six, and twelve months.
1 secondary outcome
Cognitive performance improvement and genotype
Time frame: 1 year
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 2 Mar 2020.
- UCLA Longevity CenterLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing POMx in people with Healthy Volunteers, run by University of California, Los Angeles 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 6 inclusion and 15 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 2 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improved cognitive performance (time frame: 1 year). 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 2 Mar 2020; AzTrials last refreshed its copy on 31 Oct 2026.