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Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects (POMEcardio)

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ClinicalTrials.gov Identifier: NCT02061098
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : April 14, 2015
Sponsor:
Collaborators:
Universidad Católica San Antonio de Murcia
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
Juan Carlos Espín de Gea, National Research Council, Spain

Tracking Information
First Submitted Date  ICMJE February 7, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02061098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • Change in serum lipids and lipoproteins levels [ Time Frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks ]
    Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
  • Change in serum sICAM, sVCAM and hsCRP [ Time Frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks ]
    Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
  • Change in fecal microbiota [ Time Frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks ]
    Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
  • 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 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.
  • 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 ]
    Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Overweight
Intervention  ICMJE
  • Dietary Supplement: Pomegranate extract-first dose-Group A
    Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
    Other Name: Group A consumes pomegranate extract (first dose)
  • Dietary Supplement: Placebo-first dose-Group B
    Group B will consume 1 daily capsules of placebo for 3 weeks.
    Other Name: Group B consumes placebo (first dose)
  • Dietary Supplement: Pomegranate extract-first dose-Group B
    After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
    Other Name: Group B consumes pomegranate extract (first dose)
  • Dietary Supplement: Placebo-first dose-Group A
    After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
    Other Name: Group A consumes placebo (first dose)
  • Dietary Supplement: Pomegranate extract-second dose-Group A
    After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
    Other Name: Group A consumes pomegranate extract (second dose)
  • Dietary Supplement: Placebo-second dose-Group B
    After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
    Other Name: Group B consumes placebo (second dose)
  • Dietary Supplement: Pomegranate extract-second dose-Group B
    After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
    Other Name: Group B consumes pomegranate extract (second dose)
  • Dietary Supplement: Placebo-second dose-Group A
    After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
    Other Name: Group A consumes placebo (second dose)
Study Arms  ICMJE
  • Experimental: Pomegranate extract

    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.

    Interventions:
    • 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 Comparator: Placebo

    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.

    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061098
Other Study ID Numbers  ICMJE CEBAS-CSIC-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan Carlos Espín de Gea, National Research Council, Spain
Study Sponsor  ICMJE National Research Council, Spain
Collaborators  ICMJE
  • Universidad Católica San Antonio de Murcia
  • The Scientific and Technological Research Council of Turkey
Investigators  ICMJE
Principal Investigator: Dr. Juan Carlos Espín, PhD National Research Council (CEBAS-CSIC, Murcia, Spain)
PRS Account National Research Council, Spain
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP