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

Higher Council for Scientific Research (CSIC)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Overweight

Treatments: Dietary Supplement: Placebo-second dose-Group B; Dietary Supplement: Placebo-second dose-Group A; Dietary Supplement: Pomegranate extract-second dose-Group A; Dietary Supplement: Placebo-first dose-Group B; Dietary Supplement: Pomegranate extract-second dose-Group B; Dietary Supplement: Pomegranate extract-first dose-Group A; Dietary Supplement: Placebo-first dose-Group A; Dietary Supplement: Pomegranate extract-first dose-Group B

Study type: Interventional

Funder types: Other

Identifiers

NCT02061098

CEBAS-CSIC-4

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Pomegranate extract

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Pomegranate extract-first dose-Group B

Dietary Supplement: Pomegranate extract-first dose-Group A

Dietary Supplement: Pomegranate extract-second dose-Group B

Dietary Supplement: Pomegranate extract-second dose-Group A

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo-first dose-Group A

Dietary Supplement: Placebo-first dose-Group B

Dietary Supplement: Placebo-second dose-Group A

Dietary Supplement: Placebo-second dose-Group B