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)

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.

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.