Overweight
Conditions
Keywords
Pomegranate, Cardiovascular, Urolithins, Microbiota, Polyphenols, Nutraceutical, Dietary supplement
Brief 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.
Interventions
DIETARY_SUPPLEMENTPomegranate extract-first dose-Group A
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
DIETARY_SUPPLEMENTPlacebo-first dose-Group B
Group B will consume 1 daily capsules of placebo for 3 weeks.
DIETARY_SUPPLEMENTPomegranate extract-first dose-Group B
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
DIETARY_SUPPLEMENTPlacebo-first dose-Group A
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
DIETARY_SUPPLEMENTPomegranate extract-second dose-Group A
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
DIETARY_SUPPLEMENTPlacebo-second dose-Group B
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
DIETARY_SUPPLEMENTPomegranate extract-second dose-Group B
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
DIETARY_SUPPLEMENTPlacebo-second dose-Group A
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
Sponsors
Universidad Católica San Antonio de Murcia
The Scientific and Technological Research Council of Turkey
National Research Council, Spain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum oxidized LDL-cholesterol concentration | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks | Effect on circulating levels of oxidized particles of LDL-cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum lipids and lipoproteins levels | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks | Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE). |
| Change in serum sICAM, sVCAM and hsCRP | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks | Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP) |
| Change in fecal microbiota | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks | Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces |
| Number of volunteers with adverse events as a measure of safety and tolerability | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks | * 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. |
| Change in phenolics and derived metabolites in plasma, feces and urine. | Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks | Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine. |
Countries
Spain
Outcome results
None listed