Effect of Pomegranate Extract Intake on Body Composition and Blood Pressure.
NCT ID: NCT02017132
Last Updated: 2013-12-20
Study Results
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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UNKNOWN
NA
55 participants
INTERVENTIONAL
2013-04-30
2014-01-31
Brief Summary
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The fruit consists of peel, seeds and berries or arils. The peel is rich in minerals and compounds such as polyphenols, but is not an edible part of the plant. In order to harness the benefits of all parts of the fruit, the whole fruit can be crushed and powdered and then easily consumed as pomegranate extract capsules.
Pomegranate has been shown to be effective at reducing cardiovascular disease risk factors, particularly with respect to decreasing blood pressure and increasing insulin sensitivity. Dietary polyphenols may also suppress body fat growth. Recently, positive effects on fat reduction have been shown using pomegranate and its extracts. In animal models it has been shown for both extract and leaf that there were significant decrease in food consumption and body weight, inhibiting the development of obesity. In the few human studies, there appeared to be a trend towards a reduction in waist circumference and fat mass, plus a halt in body weight increase, for both juice and seed oil.
This parallel, double blinded, randomised, placebo controlled trial aims to confirm previous results concerning the effect of whole pomegranate fruit on biochemical and physiological markers using a new pomegranate extract and to conduct original work to explore its effect on body weight, measurements and fat mass. Any similar interventions have not been double blinded or used pomegranate in extract form. Changes in physiological and biochemical markers will also be investigated.
The study hypothesis is that pomegranate extract will reduce BMI and body weight, fat mass, body measurements and blood pressure.
Detailed Description
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Participants will be asked to visit the clinical lab three times. The first visit will be for baseline measurements and a 24 hour urine sample before the intervention begins; the second in week 4 for measurements only and the final visit in week 8 for measurements and the last urine collection. Blood pressure and anthropometric measurements will be taken at each visit. Urine will only be collected pre and post intervention.
The health related Quality of Life Questionnaire (Rand 36) will be administered at both the initial and final visits. This series of questions covers eight spheres of health and has been proven to be scientifically robust having been used in over 200 health related scientific trials.
Three day diet diaries will be used for recording energy intake and to determine any fluctuations in dietary intake over the study period. These will be completed by participants in the pre-intervention week and then at week 4 of the intervention. Participants complete 2 diet diaries in total.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Pomegranate extract
1.1g pomegranate extract capsule administered daily to each participant for 8 weeks
Pomegranate extract
Placebo capsule
1.1g placebo capsule taken daily by each participant for 8 weeks
No interventions assigned to this group
Interventions
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Pomegranate extract
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* recent weight loss within 2 months preceding the study;
* pregnancy;
* lactation;
* allergies to pomegranate.
18 Years
65 Years
ALL
Yes
Sponsors
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PomeGreat
UNKNOWN
Queen Margaret University
OTHER
Responsible Party
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Angela Stockton
Ph.D. Researcher
Principal Investigators
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Angela EV Stockton, MSc
Role: PRINCIPAL_INVESTIGATOR
Queen Margaret University
Locations
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Queen Margaret University
Musselburgh, Edinburgh, United Kingdom
Countries
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Other Identifiers
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POM-02Extr
Identifier Type: -
Identifier Source: org_study_id