Metabolic SyndromeNCT04075032
Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients
A study testing Pomegranate extract in people with Metabolic Syndrome, run by National Research Council, Spain at 1 site in Spain.
Trial summary
The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers, and iii) the modulation of the gut microbiota. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Pomegranate extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2018to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index >30 kg/m2 or waist circumference >94/80 cm (males/females) in European-Caucasians subjects, plus two of the following:
- Triglycerides >150 mg/dL or under treatment against hypertrigliceridemia.
- Fasting glucose ≥100 mg/dL
- Diagnosed type 2 diabetes mellitus
- HDL-cholesterol (mg/dl) <40/50 (males/females) or under treatment against low HDLc values.
- Systolic blood pressure >130 mmHg o diastolic blood pressure >85 mmHg, or under anti-hypertensive drug treatment.
Who cannot join
- Age under 18 years
- Pregnancy or breastfeeding
- Antibiotic treatment within one month before inclusion in the trial
- Pomegranate allergy or intolerance (known or suspected)
- Chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease, etc.)
- Malignancies
- Consumption of botanicals or dietary supplements within one month before the inclusion and during the trial.
- Consumption of ellagitannin-rich sources within one week before the inclusion and during the trial (pomegranate, walnuts, strawberries, raspberries, tea, blackberries and oak-aged wine).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients
The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers, and iii) the modulation of the gut microbiota.
- Conditions
- Metabolic Syndrome
- Being tested
- Pomegranate extract, Placebo
- Keywords
- metabolic syndrome, pomegranate, gut microbiota, polyphenol, polymedication, inflammation, obesity, diabetes, hypertension, hyperlipidemia, urolithins
- Medical subject headings
- Metabolic Syndrome, Inflammation, Obesity, Diabetes Mellitus, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate extractDietary supplement
Pomegranate extract consumption (900 mg/day) for 4 weeks
PlaceboOther
Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate extract-1 | Experimental | Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks Receives: Dietary Supplement: Pomegranate extract |
| Placebo-1 | Placebo comparator | Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks Receives: Other: Placebo |
| Placebo-2 | Placebo comparator | Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks. This arm is the previous PE-1 after crossover and one month of wash-out Receives: Other: Placebo |
| Pomegranate extract-2 | Experimental | Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks. This arm is the previous PLA-1 after crossover and one month of wash-out. Receives: Dietary Supplement: Pomegranate extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (1 log units) of Bacteroidetes per gram of feces
Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)
Measured: Change from baseline at 30 days vs placebo
Secondary outcomes (6)
Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)
Evaluation of metabolic endotoxemia
Measured: Changes from baseline at 30 days vs placebo
Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL).
Determination of metabolic and inflammatory markers in serum samples.
Measured: Changes from baseline at 30 days vs placebo
Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).
Determination of fibrinolytic, inflammatory and metabolic markers in serum samples
Measured: Changes from baseline at 30 days vs placebo
Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)
Measurement of cell adhesion molecules in serum samples
Measured: Changes from baseline at 30 days vs placebo
Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL)
Measurement of serobiochemical variables (blood glucose and lipids levels) in serum samples
Measured: Changes from baseline at 30 days vs placebo
Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases
SNP genotyping of patients (DNA extracted from whole blood)
Measured: Baseline values at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start10 Jun 2018
- Primary completion21 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled and crossover trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Hospital General Universitario Reina Sofía de Murcia
- Responsible party
- Principal investigator, Juan Carlos Espín de Gea, National Research Council, Spain
- Investigators
- Juan C Espín, PhD, Principal investigator, Spanish National Research Council (CSIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075032
- Sponsor's protocol ID
- AGL2015-64124-R(2)
- Status last verified
- Sep 2020
- First submitted
- 22 Aug 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Pomegranate Extract on Metabolic and Inflammatory Markers, and the Gut Microbiota of Poly-medicated Metabolic Syndrome Patients
- ClinicalTrials.gov ID
- NCT04075032
- Acronym / sponsor ID
- AGL2015-64124-R(2)
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, pomegranate, gut microbiota, polyphenol, polymedication, inflammation, obesity, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Hospital General Universitario Reina Sofía de Murcia
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Aug 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.
The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers, and iii) the modulation of the gut microbiota.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled and crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Pomegranate extract-1 | Experimental | Dietary Supplement: Pomegranate extractConsumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks |
| Placebo-1 | Placebo comparator | Other: PlaceboConsumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks |
| Placebo-2 | Placebo comparator | Other: PlaceboConsumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks. This arm is the previous PE-1 after crossover and one month of wash-out |
| Pomegranate extract-2 | Experimental | Dietary Supplement: Pomegranate extractConsumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks. This arm is the previous PLA-1 after crossover and one month of wash-out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index >30 kg/m2 or waist circumference >94/80 cm (males/females) in European-Caucasians subjects, plus two of the following:
- Triglycerides >150 mg/dL or under treatment against hypertrigliceridemia.
- Fasting glucose ≥100 mg/dL
- Diagnosed type 2 diabetes mellitus
- HDL-cholesterol (mg/dl) <40/50 (males/females) or under treatment against low HDLc values.
Key exclusion criteria (8 listed)
- Age under 18 years
- Pregnancy or breastfeeding
- Antibiotic treatment within one month before inclusion in the trial
- Pomegranate allergy or intolerance (known or suspected)
- Chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease, etc.)
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 extractPomegranate extract consumption (900 mg/day) for 4 weeks | Dietary supplement | Pomegranate extract-1, Pomegranate extract-2 |
| PlaceboPlacebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks | Other | Placebo-1, Placebo-2 |
Primary outcome
Change (1 log units) of Bacteroidetes per gram of feces
Time frame: Change from baseline at 30 days vs placebo
Modulation of gut microbiota (decrease Firmicutes to Bacteroidetes ratio)
6 secondary outcomes
Change (10%) of circulating levels of lipopolysaccharide binding protein (LBP)
Time frame: Changes from baseline at 30 days vs placebo
Change (10%) of ghrelin, TNF-α, GLP-1, IL-6, PYY, resistin, HGF, MCP-1, C-Peptide, and BDNF (pg/mL).
Time frame: Changes from baseline at 30 days vs placebo
Change (10%) of PAI-1, adiponectin, RBP4, and leptin (ug/mL).
Time frame: Changes from baseline at 30 days vs placebo
Change (10%) of ICAM-1, VCAM-1, and P-selectin (ng/mL)
Time frame: Changes from baseline at 30 days vs placebo
Change (10%) of blood glucose, total cholesterol, LDLc and HDLc concentrations (mg/dL)
Time frame: Changes from baseline at 30 days vs placebo
Evaluation of genotype frequencies for 60 single nucleotide polymorphisms (SNPs) related to the incidence of obesity, metabolism, diabetes and cardiovascular diseases
Time frame: Baseline values at inclusion
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 Sep 2020.
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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.
Juan C Espín, PhD principal investigator
Spanish National Research Council (CSIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomegranate extract in people with Metabolic Syndrome, 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 6 inclusion and 8 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 Sep 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 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.
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 (1 log units) of Bacteroidetes per gram of feces (time frame: Change from baseline at 30 days vs placebo). 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 Sep 2020.