Clinical trial NCT02061098: Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Overweight
Keywords: Pomegranate
Cardiovascular
Urolithins
Microbiota
Polyphenols
Nutraceutical
Dietary supplement
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Universidad Católica San Antonio de Murcia
name: The Scientific and Technological Research Council of Turkey
First posted: 2014-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* Aged 40-65 years
* Body mass index (BMI) \>27 kg/m2
* Healthy status (no illness in the previous 3-months).

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Change in serum oxidized LDL-cholesterol concentration
timeFrame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Secondary outcomes:
measure: Change in serum lipids and lipoproteins levels
timeFrame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
measure: Change in serum sICAM, sVCAM and hsCRP
timeFrame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
measure: Change in fecal microbiota
timeFrame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
measure: Number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
measure: Change in phenolics and derived metabolites in plasma, feces and urine.
timeFrame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM (San Antonio Catholic University from Murcia)
Study officials:
affiliation: National Research Council (CEBAS-CSIC, Murcia, Spain)
name: Dr. Juan Carlos Espín, PhD
role: PRINCIPAL_INVESTIGATOR
References: