Clinical trial NCT02017132: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Diabetes
Cardiovascular Disease
Keywords: Pomegranate
Blood pressure
Body composition
Weight-loss
Fat mass
Polyphenols
Quality of Life
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: PomeGreat
First posted: 2013-12-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Changes in measurements of body mass indicators
timeFrame: Week 0, 4, 8
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: Week 0, 4, 8
Other outcomes:
measure: Changes in Quality of life
timeFrame: Week 0, 8
measure: Changes in urinary polyphenol and FRAP levels
timeFrame: Week 0, 8
measure: Change in urinary cortisol-to-cortisone ratio
timeFrame: Week 0, 8
Locations:
city: Musselburgh
country: United Kingdom
facility: Queen Margaret University
state: Edinburgh
Study officials:
affiliation: Queen Margaret University
name: Angela EV Stockton, MSc
role: PRINCIPAL_INVESTIGATOR
References: