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

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.

Conditions

• Overweight

Interventions

DIETARY_SUPPLEMENT

Pomegranate extract-first dose-Group A

Group A will consume 1 daily capsule of pomegranate extract for 3 weeks

DIETARY_SUPPLEMENT

Placebo-first dose-Group B

Group B will consume 1 daily capsules of placebo for 3 weeks.

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.

DIETARY_SUPPLEMENT

Placebo-first dose-Group A

After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.

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.

DIETARY_SUPPLEMENT

Placebo-second dose-Group B

After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.

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.

DIETARY_SUPPLEMENT

Placebo-second dose-Group A

After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia

  collaborator OTHER

• The Scientific and Technological Research Council of Turkey

  collaborator OTHER

• National Research Council, Spain

  lead OTHER_GOV

Principal Investigators

• Dr. Juan Carlos Espín, PhD · National Research Council (CEBAS-CSIC, Murcia, Spain)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2014-08-31

Completion

2014-12-31

Countries

• Spain

Study Locations