Effect of Biophenol-rich Pomegranate Extract Intake on Blood Pressure, Hormones, Body Composition and Quality of Life in Healthy Volunteers. (POM-01Expl)

Effect of Pomegranate Extract Intake on Anthropometric, Metabolic and Hormonal Parameters in Human Volunteers: a Double Blinded, Placebo Controlled, Randomised, Exploratory 4 Week Trial.

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factors
• Intervention / Treatment: Dietary supplement: Pomegranate extract

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH21 6UU
      • Queen Margaret University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pomegranate extract capsule; All participants receive 1.1 g pomegranate extract capsule daily for 4 weeks	Dietary supplement: Pomegranate extract; All randomised participants to the intervention arm receive one pomegranate capsule daily for 4 weeks; Other Names: Pomegreat PurePlus
Placebo Comparator: Placebo capsule; All participants receive a 1.1g placebo capsule daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Change in systolic and diastolic blood pressure	Week 0, 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in insulin sensitivity	Measured through fasting insulin and glucose	Week 0, 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
stress hormone levels	Measured via saliva using ELISA methods	Week 0, 4
Changes in body composition	Assessed via BMI, body fat mass	week 0, 4
Quality of Life	Assessed by the scored Rand 36 Questionnaire	Week 0, 4

Collaborators and Investigators

• Sponsor: Queen Margaret University
• Collaborators: PomeGreat
• Investigators: Study Director: Emad AS Al-Dujaili, Ph.D., Queen Margaret University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Quality of life; Body composition; Cortisol; Blood pressure; Insulin sensitivity; Pomegranate
• Other Study ID Numbers: POM-01Expl (Other Identifier: Queen Margaret University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No