A Phase 1/2 interventional study of Pomegranate extract-first dose-Group A and Placebo-first dose-Group B in Overweight, sponsored by National Research Council, Spain. Completed at 1 site in Spain. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-14.
Sponsored by National Research Council, Spain · Phase 1/2, Interventional, and Treatment
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 50 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →National Research Council, Spain is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: Pomegranate extract-first dose-Group A · Dietary Supplement: Pomegranate extract-first dose-Group B · Dietary Supplement: Pomegranate extract-second dose-Group A · Dietary Supplement: Pomegranate extract-second dose-Group B
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.
Dietary Supplement: Placebo-first dose-Group B · Dietary Supplement: Placebo-first dose-Group A · Dietary Supplement: Placebo-second dose-Group B · Dietary Supplement: Placebo-second dose-Group A
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
Also known as: Group A consumes pomegranate extract (first dose)
Group B will consume 1 daily capsules of placebo for 3 weeks.
Also known as: Group B consumes placebo (first dose)
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
Also known as: Group B consumes pomegranate extract (first dose)
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
Also known as: Group A consumes placebo (first dose)
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
Also known as: Group A consumes pomegranate extract (second dose)
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
Also known as: Group B consumes placebo (second dose)
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
Also known as: Group B consumes pomegranate extract (second dose)
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
Also known as: Group A consumes placebo (second dose)
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
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Research Council, Spain