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

NCT02061098 | Completed Phase 1 DMC

• 1 other identifier: CEBAS-CSIC-4
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Keywords

Pomegranate; Cardiovascular; Urolithins; Microbiota; Polyphenols; Nutraceutical; Dietary supplement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in serum lipids and lipoproteins levels

  Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks

• Change in serum sICAM, sVCAM and hsCRP

  Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks

• Change in fecal microbiota

  Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks

• 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 phenolics and derived metabolites in plasma, feces and urine.

  Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks

Study Arms (2)

Pomegranate extract

EXPERIMENTAL

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.

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

Placebo

PLACEBO COMPARATOR

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.

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

Interventions

Pomegranate extract-first dose-Group A DIETARY_SUPPLEMENT

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

Also known as: Group A consumes pomegranate extract (first dose)

Pomegranate extract

Placebo-first dose-Group B DIETARY_SUPPLEMENT

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

Also known as: Group B consumes placebo (first dose)

Placebo

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.

Also known as: Group B consumes pomegranate extract (first dose)

Pomegranate extract

Placebo-first dose-Group A DIETARY_SUPPLEMENT

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

Also known as: Group A consumes placebo (first dose)

Placebo

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.

Also known as: Group A consumes pomegranate extract (second dose)

Pomegranate extract

Placebo-second dose-Group B DIETARY_SUPPLEMENT

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

Also known as: Group B consumes placebo (second dose)

Placebo

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.

Also known as: Group B consumes pomegranate extract (second dose)

Pomegranate extract

Placebo-second dose-Group A DIETARY_SUPPLEMENT

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

Also known as: Group A consumes placebo (second dose)

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40-65 years
• Body mass index (BMI) \>27 kg/m2
• Healthy status (no illness in the previous 3-months).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Council, Spain: lead
• Universidad Católica San Antonio de Murcia: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

UCAM (San Antonio Catholic University from Murcia)

Murcia, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Juan Carlos Espín, PhD

  National Research Council (CEBAS-CSIC, Murcia, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Research Professor

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 12, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

ES (1)