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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
PomeGreat
Information provided by (Responsible Party):
Angela Stockton, Queen Margaret University
ClinicalTrials.gov Identifier:
NCT02017132
First received: December 16, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Diabetes
Cardiovascular Disease
Dietary Supplement: Pomegranate extract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Queen Margaret University:

Primary Outcome Measures:
  • Changes in measurements of body mass indicators [ Time Frame: Week 0, 4, 8 ] [ Designated as safety issue: No ]

    These indicators are:

    Body weight; height; BMI; waist, hip and mid-upper arm circumference; fat and fat free mass.



Secondary Outcome Measures:
  • Changes in blood pressure [ Time Frame: Week 0, 4, 8 ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressure are taken when volunteers are supine


Other Outcome Measures:
  • Changes in Quality of life [ Time Frame: Week 0, 8 ] [ Designated as safety issue: No ]
    Administered through the Rand 36 questionnaire

  • Changes in urinary polyphenol and FRAP levels [ Time Frame: Week 0, 8 ] [ Designated as safety issue: No ]
    Measured using the 24hr urine collection

  • Change in urinary cortisol-to-cortisone ratio [ Time Frame: Week 0, 8 ] [ Designated as safety issue: No ]
    Determined via the 24hr urine collection


Enrollment: 55
Study Start Date: April 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pomegranate extract
1.1g pomegranate extract capsule administered daily to each participant for 8 weeks
Dietary Supplement: Pomegranate extract
Other Name: Pomegreat PurePlus
Placebo Comparator: Placebo capsule
1.1g placebo capsule taken daily by each participant for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017132

Locations
United Kingdom
Queen Margaret University
Musselburgh, Edinburgh, United Kingdom, EH21 6UU
Sponsors and Collaborators
Queen Margaret University
PomeGreat
Investigators
Principal Investigator: Angela EV Stockton, MSc Queen Margaret University
  More Information

No publications provided

Responsible Party: Angela Stockton, Ph.D. Researcher, Queen Margaret University
ClinicalTrials.gov Identifier: NCT02017132     History of Changes
Other Study ID Numbers: POM-02Extr
Study First Received: December 16, 2013
Last Updated: December 16, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Margaret University:
Pomegranate
Blood pressure
Body composition
Weight-loss
Fat mass
Polyphenols
Quality of Life

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014