Pomegranate Consumption by Poly-medicated Metabolic Syndrome Patients

Higher Council for Scientific Research (CSIC)

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Placebo; Dietary Supplement: Pomegranate extract

Study type: Interventional

Funder types: Other

Identifiers

NCT04075032

AGL2015-64124-R(2)

Details and patient eligibility

About

The objective is to evaluate whether the medication in polymedicated metabolic syndrome patients could determine the effects of a pomegranate extract on i) metabolic markers, ii) inflammatory markers, and iii) the modulation of the gut microbiota.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index >30 kg/m2 or waist circumference >94/80 cm (males/females) in European-Caucasians subjects, plus two of the following:
• Triglycerides >150 mg/dL or under treatment against hypertrigliceridemia.
• Fasting glucose ≥100 mg/dL
• Diagnosed type 2 diabetes mellitus
• HDL-cholesterol (mg/dl) <40/50 (males/females) or under treatment against low HDLc values.
• Systolic blood pressure >130 mmHg o diastolic blood pressure >85 mmHg, or under anti-hypertensive drug treatment.

Exclusion criteria

• Age under 18 years
• Pregnancy or breastfeeding
• Antibiotic treatment within one month before inclusion in the trial
• Pomegranate allergy or intolerance (known or suspected)
• Chronic intestinal inflammatory diseases (ulcerative colitis, Crohn's disease, etc.)
• Malignancies
• Consumption of botanicals or dietary supplements within one month before the inclusion and during the trial.
• Consumption of ellagitannin-rich sources within one week before the inclusion and during the trial (pomegranate, walnuts, strawberries, raspberries, tea, blackberries and oak-aged wine).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

Pomegranate extract-1

Experimental group

Description:

Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks

Treatment:

Dietary Supplement: Pomegranate extract

Placebo-1

Placebo Comparator group

Description:

Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks

Treatment:

Other: Placebo

Placebo-2

Placebo Comparator group

Description:

Consumption of 2 daily capsules (900 mg microcrystalline cellulose, PLA) for 4 weeks. This arm is the previous PE-1 after crossover and one month of wash-out

Treatment:

Other: Placebo

Pomegranate extract-2

Experimental group

Description:

Consumption of 2 daily capsules (900 mg pomegranate extract, PE) for 4 weeks. This arm is the previous PLA-1 after crossover and one month of wash-out.

Treatment:

Dietary Supplement: Pomegranate extract