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

NCT02017132 | Unknown DMC

• 1 other identifier: POM-02Extr
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes; Cardiovascular Disease

Keywords

Pomegranate; Blood pressure; Body composition; Weight-loss; Fat mass; Polyphenols; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Changes in measurements of body mass indicators

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

  Week 0, 4, 8

Secondary Outcomes (1)

• Changes in blood pressure

  Week 0, 4, 8

Other Outcomes (3)

• Changes in Quality of life

  Week 0, 8

• Changes in urinary polyphenol and FRAP levels

  Week 0, 8

• Change in urinary cortisol-to-cortisone ratio

  Week 0, 8

Study Arms (2)

Pomegranate extract

ACTIVE COMPARATOR

1.1g pomegranate extract capsule administered daily to each participant for 8 weeks

Dietary Supplement: Pomegranate extract

Placebo capsule

PLACEBO COMPARATOR

1.1g placebo capsule taken daily by each participant for 8 weeks

Interventions

Pomegranate extract DIETARY_SUPPLEMENT

Also known as: Pomegreat PurePlus

Pomegranate extract

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Taking medications for heart, liver or kidney disease, or diabetes;
• recent weight loss within 2 months preceding the study;
• pregnancy;
• lactation;
• allergies to pomegranate.

Sponsors & Collaborators

• Queen Margaret University: lead
• PomeGreat: collaborator

Study Sites (1)

Queen Margaret University

Musselburgh, Edinburgh, EH21 6UU, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Cardiovascular Diseases; Weight Loss

Interventions

pomegranate fruit rind

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• Angela EV Stockton, MSc

  Queen Margaret University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Researcher

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

GB (1)