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

Overweight Clinical Trial

— POMEcardio  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061098
• Other study ID #: CEBAS-CSIC-4
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 7, 2014
• Last updated: April 13, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: National Research Council, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• Pomegranate extract-first dose-Group A
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
• Placebo-first dose-Group B
Group B will consume 1 daily capsules of placebo for 3 weeks.
• Pomegranate extract-first dose-Group B
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
• Placebo-first dose-Group A
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
• Pomegranate extract-second dose-Group A
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
• Placebo-second dose-Group B
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
• Pomegranate extract-second dose-Group B
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
• Placebo-second dose-Group A
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.

Locations

Country	Name	City	State
Spain	UCAM (San Antonio Catholic University from Murcia)	Murcia

Sponsors (3)

Lead Sponsor	Collaborator
National Research Council, Spain	The Scientific and Technological Research Council of Turkey, Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum oxidized LDL-cholesterol concentration	Effect on circulating levels of oxidized particles of LDL-cholesterol	Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks	No
Secondary	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).	Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks	No
Secondary	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)	Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks	No
Secondary	Change in fecal microbiota	Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces	Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks	No
Secondary	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.	Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks	Yes
Secondary	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.	Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks	No