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Effect of Pomegranate Extract Intake on Body Composition and Blood Pressure.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02017132
Recruitment Status : Unknown
Verified December 2013 by Angela Stockton, Queen Margaret University.
Recruitment status was:  Active, not recruiting
First Posted : December 20, 2013
Last Update Posted : December 20, 2013
Information provided by (Responsible Party):
Angela Stockton, Queen Margaret University

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE December 20, 2013
Last Update Posted Date December 20, 2013
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Changes in measurements of body mass indicators [ Time Frame: Week 0, 4, 8 ]
These indicators are: Body weight; height; BMI; waist, hip and mid-upper arm circumference; fat and fat free mass.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Changes in blood pressure [ Time Frame: Week 0, 4, 8 ]
Systolic and diastolic blood pressure are taken when volunteers are supine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 16, 2013)
  • Changes in Quality of life [ Time Frame: Week 0, 8 ]
    Administered through the Rand 36 questionnaire
  • Changes in urinary polyphenol and FRAP levels [ Time Frame: Week 0, 8 ]
    Measured using the 24hr urine collection
  • Change in urinary cortisol-to-cortisone ratio [ Time Frame: Week 0, 8 ]
    Determined via the 24hr urine collection
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Effect of Pomegranate Extract Intake on Body Composition and Blood Pressure.
Official Title  ICMJE The Effect of Pomegranate Extract on Anthropometric, Physiological and Biochemical Parameters in Human Volunteers: an 8 Week Parallel, Double Blinded, Placebo Controlled, Randomised Trial.
Brief Summary

Pomegranate has gained widespread popularity since the health effects of the whole fruit, as well as its juices and extracts, have been studied in relation to a variety of chronic conditions such as hypertension, diabetes, obesity, cancer and cardiovascular disease.

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

This is a parallel, double blinded, placebo controlled, randomised trial. It will be conducted over an 8 week intervention phase, plus a pre-intervention registration and preparation period. Participants will be randomly assigned to either the pomegranate extract or placebo groups. One capsule of Pomegranate or placebo will be taken after the same time daily meal with water for 8 weeks.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Diabetes
  • Cardiovascular Disease
Intervention  ICMJE Dietary Supplement: Pomegranate extract
Other Name: Pomegreat PurePlus
Study Arms  ICMJE
  • Active Comparator: Pomegranate extract
    1.1g pomegranate extract capsule administered daily to each participant for 8 weeks
    Intervention: Dietary Supplement: Pomegranate extract
  • Placebo Comparator: Placebo capsule
    1.1g placebo capsule taken daily by each participant for 8 weeks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 16, 2013)
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers with a BMI within the range of 18-34.9 kg/m².

Exclusion Criteria:

  • Taking medications for heart, liver or kidney disease, or diabetes;
  • recent weight loss within 2 months preceding the study;
  • pregnancy;
  • lactation;
  • allergies to pomegranate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02017132
Other Study ID Numbers  ICMJE POM-02Extr
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Angela Stockton, Queen Margaret University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Queen Margaret University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE PomeGreat
Investigators  ICMJE
Principal Investigator: Angela EV Stockton, MSc Queen Margaret University
PRS Account Queen Margaret University
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP