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

Study Overview
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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.

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

Conditions
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Cardiovascular Risk Factors

Intervention / Treatment
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* Dietary Supplement: Pomegranate extract


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pomegranate extract capsule<br>All participants receive 1.1 g pomegranate extract capsule daily for 4 weeks | Dietary Supplement: Pomegranate extract<br>* All randomised participants to the intervention arm receive one pomegranate capsule daily for 4 weeks<br>* Other names: Pomegreat PurePlus;|
| Placebo Comparator: Placebo capsule<br>All participants receive a 1.1g placebo capsule daily for 4 weeks | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pomegranate, Blood pressure, Insulin sensitivity, Cortisol, Quality of life, Body composition