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

Primary Purpose

Overweight

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
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
Placebo-second dose-Group B
Pomegranate extract-second dose-Group B
Placebo-second dose-Group A
Sponsored by
National Research Council, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Pomegranate, Cardiovascular, Urolithins, Microbiota, Polyphenols, Nutraceutical, Dietary supplement

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCAM (San Antonio Catholic University from Murcia)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pomegranate extract

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in serum oxidized LDL-cholesterol concentration
Effect on circulating levels of oxidized particles of LDL-cholesterol

Secondary Outcome Measures

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).
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)
Change in fecal microbiota
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
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.
Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.

Full Information

First Posted
February 7, 2014
Last Updated
April 13, 2015
Sponsor
National Research Council, Spain
Collaborators
Universidad Católica San Antonio de Murcia, The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT02061098
Brief Title
Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects
Acronym
POMEcardio
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Council, Spain
Collaborators
Universidad Católica San Antonio de Murcia, The Scientific and Technological Research Council of Turkey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Pomegranate, Cardiovascular, Urolithins, Microbiota, Polyphenols, Nutraceutical, Dietary supplement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pomegranate extract
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate extract-first dose-Group A
Other Intervention Name(s)
Group A consumes pomegranate extract (first dose)
Intervention Description
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo-first dose-Group B
Other Intervention Name(s)
Group B consumes placebo (first dose)
Intervention Description
Group B will consume 1 daily capsules of placebo for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate extract-first dose-Group B
Other Intervention Name(s)
Group B consumes pomegranate extract (first dose)
Intervention Description
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo-first dose-Group A
Other Intervention Name(s)
Group A consumes placebo (first dose)
Intervention Description
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate extract-second dose-Group A
Other Intervention Name(s)
Group A consumes pomegranate extract (second dose)
Intervention Description
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo-second dose-Group B
Other Intervention Name(s)
Group B consumes placebo (second dose)
Intervention Description
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate extract-second dose-Group B
Other Intervention Name(s)
Group B consumes pomegranate extract (second dose)
Intervention Description
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo-second dose-Group A
Other Intervention Name(s)
Group A consumes placebo (second dose)
Intervention Description
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
Primary Outcome Measure Information:
Title
Change in serum oxidized LDL-cholesterol concentration
Description
Effect on circulating levels of oxidized particles of LDL-cholesterol
Time Frame
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Secondary Outcome Measure Information:
Title
Change in serum lipids and lipoproteins levels
Description
Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
Time Frame
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Title
Change in serum sICAM, sVCAM and hsCRP
Description
Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
Time Frame
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Title
Change in fecal microbiota
Description
Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
Time Frame
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Title
Number of volunteers with adverse events as a measure of safety and tolerability
Description
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.
Time Frame
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Title
Change in phenolics and derived metabolites in plasma, feces and urine.
Description
Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
Time Frame
Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Juan Carlos Espín, PhD
Organizational Affiliation
National Research Council (CEBAS-CSIC, Murcia, Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCAM (San Antonio Catholic University from Murcia)
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

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

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