NCT02061098

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

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Research Council, Spain · Other Government
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2014-02-12
• Last updated: 2015-04-14

Locations

1 site across 1 country: Spain