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Completed

NCT Number: NCT02061098

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCAM (San Antonio Catholic University from Murcia)

Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pomegranate extract-first dose-Group A

Dietary Supplement

Group A will consume 1 daily capsule of pomegranate extract for 3 weeks

Other names: Group A consumes pomegranate extract (first dose)

Placebo-first dose-Group B

Dietary Supplement

Group B will consume 1 daily capsules of placebo for 3 weeks.

Other names: Group B consumes placebo (first dose)

Pomegranate extract-first dose-Group B

Dietary Supplement

After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.

Other names: Group B consumes pomegranate extract (first dose)

Placebo-first dose-Group A

Dietary Supplement

After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.

Other names: Group A consumes placebo (first dose)

Pomegranate extract-second dose-Group A

Dietary Supplement

After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.

Other names: Group A consumes pomegranate extract (second dose)

Placebo-second dose-Group B

Dietary Supplement

After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.

Other names: Group B consumes placebo (second dose)

Pomegranate extract-second dose-Group B

Dietary Supplement

After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.

Other names: Group B consumes pomegranate extract (second dose)

Placebo-second dose-Group A

Dietary Supplement

After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.

Other names: Group A consumes placebo (second dose)

Primary outcomes

  1. Change in serum oxidized LDL-cholesterol concentration

    Time frame: 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 outcomes

  1. Change in serum lipids and lipoproteins levels

    Time frame: 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).

  2. Change in serum sICAM, sVCAM and hsCRP

    Time frame: 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)

  3. Change in fecal microbiota

    Time frame: 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

  4. Number of volunteers with adverse events as a measure of safety and tolerability

    Time frame: 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.

  5. Change in phenolics and derived metabolites in plasma, feces and urine.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • The Scientific and Technological Research Council of Turkey
  • Universidad Católica San Antonio de Murcia

Registry information

Official study 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)

Acronym: POMEcardio

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2014
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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