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

• ClinicalTrials.gov Identifier: NCT02017132
• Recruitment Status: Unknown
• First Posted: December 20, 2013
• Last Update Posted: December 20, 2013
• Sponsor: Queen Margaret University
• Collaborator: PomeGreat
• Information provided by (Responsible Party): Angela Stockton, Queen Margaret University

Tracking Information

• First Submitted Date: December 16, 2013
• First Posted Date: December 20, 2013
• Last Update Posted Date: December 20, 2013
• Study Start Date: April 2013
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: 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: Effect of Pomegranate Extract Intake on Body Composition and Blood Pressure.
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Obesity
• Diabetes
• Cardiovascular Disease

Intervention

Dietary Supplement: Pomegranate extract

Other Name: Pomegreat PurePlus

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: December 16, 2013): 55
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: January 2014
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02017132
• Other Study ID Numbers: POM-02Extr
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Angela Stockton, Queen Margaret University
• Original Responsible Party: Same as current
• Current Study Sponsor: Queen Margaret University
• Original Study Sponsor: Same as current
• Collaborators: PomeGreat

Investigators

• Principal Investigator: Angela EV Stockton, MSc; Queen Margaret University

• PRS Account: Queen Margaret University
• Verification Date: December 2013