Trial record 2 of 54 for:    pomegranate

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Universidad Católica San Antonio de Murcia
TUBİTAK Marmara Research Center
Information provided by (Responsible Party):
Juan Carlos Espín de Gea, National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT02061098
First received: February 7, 2014
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Overweight
Dietary Supplement: Pomegranate extract-first dose-Group A
Dietary Supplement: Placebo-first dose-Group B
Dietary Supplement: Pomegranate extract-first dose-Group B
Dietary Supplement: Placebo-first dose-Group A
Dietary Supplement: Pomegranate extract-second dose-Group A
Dietary Supplement: Placebo-second dose-Group B
Dietary Supplement: Pomegranate extract-second dose-Group B
Dietary Supplement: Placebo-second dose-Group A
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by National Research Council, Spain:

Primary Outcome Measures:
  • Change in serum oxidized LDL-cholesterol concentration [ Time Frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks ] [ Designated as safety issue: No ]
    Effect on circulating levels of oxidized particles of LDL-cholesterol


Secondary Outcome Measures:
  • Change in serum lipids and lipoproteins levels [ Time Frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: No ]
    Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.


Estimated Enrollment: 50
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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: 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: 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: 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)
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.

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: 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: 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: 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)

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061098

Locations
Spain
UCAM (San Antonio Catholic University from Murcia)
Murcia, Spain, 30107
Sponsors and Collaborators
National Research Council, Spain
Universidad Católica San Antonio de Murcia
TUBİTAK Marmara Research Center
Investigators
Principal Investigator: Dr. Juan Carlos Espín, PhD National Research Council (CEBAS-CSIC, Murcia, Spain)
  More Information

No publications provided

Responsible Party: Juan Carlos Espín de Gea, Full Research Professor, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT02061098     History of Changes
Other Study ID Numbers: CEBAS-CSIC-4
Study First Received: February 7, 2014
Last Updated: February 11, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by National Research Council, Spain:
Pomegranate
Cardiovascular
Urolithins
Microbiota
Polyphenols
Nutraceutical
Dietary supplement

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014