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Effect of Biophenol-rich Pomegranate Extract Intake on Blood Pressure, Hormones, Body Composition and Quality of Life in Healthy Volunteers.

NCT ID: NCT02005939

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-07-31

Brief Summary

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Biophenols can act as powerful antioxidants. Pomegranate (Punica granatum) provides a rich and varied source of biophenols with the most abundant being ellagitannins, tannins, anthocyanins, ellagic and gallic acids. Interest in antioxidant polyphenol-rich pomegranate products has increased in recent years with growing reports of potential health benefits. Pomegranate biophenols have been noted to lower systolic blood pressure, salivary stress hormones and increase insulin sensitivity in previous trials involving participants who have cardiovascular disease, but few studies have been conducted recruiting healthy volunteers, and those have made use of pomegranate juice rather than extract.

The aim of this parallel study is to investigate the effect of pomegranate extract supplementation on blood pressure, lipid profiles, salivary stress hormones, insulin sensitivity, body composition and the perceived quality of life in healthy volunteers over 4 weeks.

It hypothesizes that consumption of biophenol-rich Pomegranate extract could increase insulin sensitivity and perceived quality of life while decreasing blood pressure, body measurements and stress hormones in healthy individuals.

Detailed Description

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After randomisation to a study arm, eligible participants will consume either one pomegranate extract or placebo capsule (identical in appearance) daily, for a period of 4 weeks. The pomegranate capsule contains 650mg of pomegranate extract (240 mg punicalagins and 350mg total biophenols) and the placebo, maltodextrin.

Participants will be required to attend the university clinic lab twice, having fasted overnight, with all measurements being taken pre and post study at 4 weeks. Blood, saliva and 24 hr urine samples will be provided. Body weight and composition, dietary habits and quality of life will also be measured. The well validated health related Quality of Life Questionnaire (Rand 36) will be administered pre- and post-intervention. This series of questions covers eight spheres of health. The physical health component considers physical functioning, physical role, bodily pain and general health. The mental health aspect examines vitality, social functioning, emotional role and general mental health. Anthropometric measurements recorded will be height, weight, waist, mid upper arm circumference. Bioelectrical impedance analysis (BIA), which measures conductivity from hand to foot, calculating both body fat and fat free mass, will also be performed.

Pre and post study comparison of the amount of polyphenols in 24 hr urine samples provided, alongside capsule consumption checks, will measure compliance. A 3 day diet diary record, will be used for recording energy intake and to highlight any fluctuations in dietary intake over the study period.

The data will be analysed using Statistical Programme for Social Sciences (SPSS) for Windows software version 19. Differences in baseline characteristics will be examined using independent t- tests with extract and placebo groups as independent variables and outcome measures as dependent variables. Paired t-tests will determine any individual differences between pre and post biochemical markers and anthropometric measurements. ANCOVAs will determine the overall differences between the independent groups.

This exploratory study will provide a foundation for and refine the outcome measures required for a larger future trial.

Conditions

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Cardiovascular Risk Factors

Keywords

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Pomegranate Blood pressure Insulin sensitivity Cortisol Quality of life Body composition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pomegranate extract capsule

All participants receive 1.1 g pomegranate extract capsule daily for 4 weeks

Group Type EXPERIMENTAL

Pomegranate extract

Intervention Type DIETARY_SUPPLEMENT

All randomised participants to the intervention arm receive one pomegranate capsule daily for 4 weeks

Placebo capsule

All participants receive a 1.1g placebo capsule daily for 4 weeks

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Pomegranate extract

All randomised participants to the intervention arm receive one pomegranate capsule daily for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Pomegreat PurePlus

Eligibility Criteria

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Inclusion Criteria

* Healthy participants
* BMI from 18-35
* Males and Females
* Age: 18-65 years

Exclusion Criteria

Systemic disease, including heart disease and diabetes

* Allergic reactions
* Alcohol/drug abuse
* Immunological conditions
* Pregnancy or lactation
* Liver and kidney disease
* Management for weight control within the last 2 months
* Heavy smokers
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PomeGreat

UNKNOWN

Sponsor Role collaborator

Queen Margaret University

OTHER

Sponsor Role lead

Responsible Party

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Angela Stockton

P.h.D. Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emad AS Al-Dujaili, Ph.D.

Role: STUDY_DIRECTOR

Queen Margaret University

Locations

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Queen Margaret University

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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POM-01Expl

Identifier Type: OTHER

Identifier Source: secondary_id

POM-01Expl

Identifier Type: -

Identifier Source: org_study_id