OverweightPhase 1/2POMEcardioNCT02061098
Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects
A Phase 1/2 study testing Pomegranate extract-first dose-Group A, Pomegranate extract-first dose-Group B and Pomegranate extract-second dose-Group A in people with Overweight, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Pomegranate extract-first dose-Group A, Pomegranate extract-first dose-Group B and Pomegranate extract-second dose-Group A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Dec 2014
- Phase
- Phase 1/2
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40-65 years
- Body mass index (BMI) >27 kg/m2
- Healthy status (no illness in the previous 3-months).
Who cannot join
- Smoking.
- Pregnancy/lactation.
- Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- Previous gastrointestinal surgery
- Recent use of antibiotics (within 1-month prior to the study)
- Suspected hypersensitivity to pomegranate or any of its components
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- Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
- Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
- Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.
Trial locations and contacts
1 site in 1 country.
Spain1 site
UCAM (San Antonio Catholic University from Murcia)
Murcia, Murcia, 30107
About this study
Official title: Effect of an Ellagitannin Rich Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects. A Double-blind, Cross-over, Dose-response, Randomized, Placebo-controlled Trial (The POMEcardio Study)
The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.
The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.
- Conditions
- Overweight
- Being tested
- Pomegranate extract-first dose-Group A, Placebo-first dose-Group B, Pomegranate extract-first dose-Group B, Placebo-first dose-Group A, Pomegranate extract-second dose-Group A
- Keywords
- Pomegranate, Cardiovascular, Urolithins, Microbiota, Polyphenols, Nutraceutical, Dietary supplement
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate extract-first dose-Group ADietary supplement
Also called Group A consumes pomegranate extract (first dose)
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
Placebo-first dose-Group BDietary supplement
Also called Group B consumes placebo (first dose)
Group B will consume 1 daily capsules of placebo for 3 weeks.
Pomegranate extract-first dose-Group BDietary supplement
Also called Group B consumes pomegranate extract (first dose)
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
Placebo-first dose-Group ADietary supplement
Also called Group A consumes placebo (first dose)
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
Pomegranate extract-second dose-Group ADietary supplement
Also called Group A consumes pomegranate extract (second dose)
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
Placebo-second dose-Group BDietary supplement
Also called Group B consumes placebo (second dose)
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
Pomegranate extract-second dose-Group BDietary supplement
Also called Group B consumes pomegranate extract (second dose)
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
Placebo-second dose-Group ADietary supplement
Also called Group A consumes placebo (second dose)
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate extract | Experimental | Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo.
Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. Receives: Dietary Supplement: Pomegranate extract-first dose-Group A; Dietary Supplement: Pomegranate extract-first dose-Group B; Dietary Supplement: Pomegranate extract-second dose-Group A; Dietary Supplement: Pomegranate extract-second dose-Group B |
| Placebo | Placebo comparator | Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo.
Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. Receives: Dietary Supplement: Placebo-first dose-Group B; Dietary Supplement: Placebo-first dose-Group A; Dietary Supplement: Placebo-second dose-Group B; Dietary Supplement: Placebo-second dose-Group A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum oxidized LDL-cholesterol concentration
Effect on circulating levels of oxidized particles of LDL-cholesterol
Measured: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Secondary outcomes (5)
Change in serum lipids and lipoproteins levels
Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
Measured: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in serum sICAM, sVCAM and hsCRP
Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
Measured: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in fecal microbiota
Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
Measured: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Number of volunteers with adverse events as a measure of safety and tolerability
- Change in markers involved in hepatic and renal functions: GGT, AST, ALP, ALT, CPK, urate, creatinin, albumin, bilirubin, LDH.
- Change in hematological variables: leucocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, mean corpuscular volume, mean platelet volume, platelets, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration.
- Intolerance, dyspepsia, allergic reactions, constipation, diarrhea, abdominal pain, nausea.
Measured: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in phenolics and derived metabolites in plasma, feces and urine.
Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
Measured: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Universidad Católica San Antonio de Murcia, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Juan Carlos Espín de Gea, National Research Council, Spain
- Investigators
- Dr. Juan Carlos Espín, PhD, Principal investigator, National Research Council (CEBAS-CSIC, Murcia, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061098
- Sponsor's protocol ID
- CEBAS-CSIC-4
- Acronym
- POMEcardio
- Status last verified
- Apr 2015
- First submitted
- 7 Feb 2014
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Ellagitannin Rich Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects. A Double-blind, Cross-over, Dose-response, Randomized, Placebo-controlled Trial (The POMEcardio Study)
- ClinicalTrials.gov ID
- NCT02061098
- Acronym / sponsor ID
- POMEcardio / CEBAS-CSIC-4
- Conditions
- Overweight
- Keywords
- Pomegranate, Cardiovascular, Urolithins, Microbiota, Polyphenols, Nutraceutical, Dietary supplement
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Universidad Católica San Antonio de Murcia, The Scientific and Technological Research Council of Turkey
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Feb 2014 (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.
The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.
The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomegranate extract | Experimental | Dietary Supplement: Pomegranate extract-first dose-Group A, Dietary Supplement: Pomegranate extract-first dose-Group B, Dietary Supplement: Pomegranate extract-second dose-Group A, Dietary Supplement: Pomegranate extract-second dose-Group BCrossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo-first dose-Group B, Dietary Supplement: Placebo-first dose-Group A, Dietary Supplement: Placebo-second dose-Group B, Dietary Supplement: Placebo-second dose-Group ACrossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 40-65 years
- Body mass index (BMI) >27 kg/m2
- Healthy status (no illness in the previous 3-months).
Key exclusion criteria (9 listed)
- Smoking.
- Pregnancy/lactation.
- Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- Previous gastrointestinal surgery
- Recent use of antibiotics (within 1-month prior to the study)
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 |
|---|---|---|
| Pomegranate extract-first dose-Group AAlso: Group A consumes pomegranate extract (first dose)Group A will consume 1 daily capsule of pomegranate extract for 3 weeks | Dietary supplement | Pomegranate extract |
| Placebo-first dose-Group BAlso: Group B consumes placebo (first dose)Group B will consume 1 daily capsules of placebo for 3 weeks. | Dietary supplement | Placebo |
| Pomegranate extract-first dose-Group BAlso: Group B consumes pomegranate extract (first dose)After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks. | Dietary supplement | Pomegranate extract |
| Placebo-first dose-Group AAlso: Group A consumes placebo (first dose)After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks. | Dietary supplement | Placebo |
| Pomegranate extract-second dose-Group AAlso: Group A consumes pomegranate extract (second dose)After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks. | Dietary supplement | Pomegranate extract |
| Placebo-second dose-Group BAlso: Group B consumes placebo (second dose)After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks. | Dietary supplement | Placebo |
| Pomegranate extract-second dose-Group BAlso: Group B consumes pomegranate extract (second dose)After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks. | Dietary supplement | Pomegranate extract |
| Placebo-second dose-Group AAlso: Group A consumes placebo (second dose)After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in serum oxidized LDL-cholesterol concentration
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Effect on circulating levels of oxidized particles of LDL-cholesterol
5 secondary outcomes
Change in serum lipids and lipoproteins levels
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in serum sICAM, sVCAM and hsCRP
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in fecal microbiota
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Number of volunteers with adverse events as a measure of safety and tolerability
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in phenolics and derived metabolites in plasma, feces and urine.
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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 14 Apr 2015.
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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.
Dr. Juan Carlos Espín, PhD principal investigator
National Research Council (CEBAS-CSIC, Murcia, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pomegranate extract-first dose-Group A, Pomegranate extract-first dose-Group B and Pomegranate extract-second dose-Group A in people with Overweight, run by National Research Council, Spain at 1 site in Spain.
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 3 inclusion and 9 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 14 Apr 2015. 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 Spain. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in serum oxidized LDL-cholesterol concentration (time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks). 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 14 Apr 2015.