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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
Group B will consume 1 daily capsules of placebo for 3 weeks.
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
UCAM (San Antonio Catholic University from Murcia)
Murcia, Murcia, Spain
Change in serum oxidized LDL-cholesterol concentration
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
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).
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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)
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
Change in fecal microbiota
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
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.
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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.
Time frame: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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