Effect of Biophenol-rich Pomegranate Extract Intake on Blood Pressure, Hormones, Body Composition and Quality of Life in Healthy Volunteers. (POM-01Expl)

This study has been completed.
Sponsor:
Collaborator:
PomeGreat
Information provided by (Responsible Party):
Angela Stockton, Queen Margaret University
ClinicalTrials.gov Identifier:
NCT02005939
First received: December 4, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

Biophenols can act as powerful antioxidants. Pomegranate (Punica granatum) provides a rich and varied source of biophenols with the most abundant being ellagitannins, tannins, anthocyanins, ellagic and gallic acids. Interest in antioxidant polyphenol-rich pomegranate products has increased in recent years with growing reports of potential health benefits. Pomegranate biophenols have been noted to lower systolic blood pressure, salivary stress hormones and increase insulin sensitivity in previous trials involving participants who have cardiovascular disease, but few studies have been conducted recruiting healthy volunteers, and those have made use of pomegranate juice rather than extract.

The aim of this parallel study is to investigate the effect of pomegranate extract supplementation on blood pressure, lipid profiles, salivary stress hormones, insulin sensitivity, body composition and the perceived quality of life in healthy volunteers over 4 weeks.

It hypothesizes that consumption of biophenol-rich Pomegranate extract could increase insulin sensitivity and perceived quality of life while decreasing blood pressure, body measurements and stress hormones in healthy individuals.


Condition Intervention
Cardiovascular Risk Factors
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: Effect of Pomegranate Extract Intake on Anthropometric, Metabolic and Hormonal Parameters in Human Volunteers: a Double Blinded, Placebo Controlled, Randomised, Exploratory 4 Week Trial.

Resource links provided by NLM:


Further study details as provided by Queen Margaret University:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: Week 0, 4 ] [ Designated as safety issue: No ]
    Change in systolic and diastolic blood pressure


Secondary Outcome Measures:
  • Changes in insulin sensitivity [ Time Frame: Week 0, 4 ] [ Designated as safety issue: No ]
    Measured through fasting insulin and glucose


Other Outcome Measures:
  • stress hormone levels [ Time Frame: Week 0, 4 ] [ Designated as safety issue: No ]
    Measured via saliva using ELISA methods

  • Changes in body composition [ Time Frame: week 0, 4 ] [ Designated as safety issue: No ]
    Assessed via BMI, body fat mass

  • Quality of Life [ Time Frame: Week 0, 4 ] [ Designated as safety issue: No ]
    Assessed by the scored Rand 36 Questionnaire


Enrollment: 29
Study Start Date: April 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pomegranate extract capsule
All participants receive 1.1 g pomegranate extract capsule daily for 4 weeks
Dietary Supplement: Pomegranate extract
All randomised participants to the intervention arm receive one pomegranate capsule daily for 4 weeks
Other Name: Pomegreat PurePlus
Placebo Comparator: Placebo capsule
All participants receive a 1.1g placebo capsule daily for 4 weeks

Detailed Description:

After randomisation to a study arm, eligible participants will consume either one pomegranate extract or placebo capsule (identical in appearance) daily, for a period of 4 weeks. The pomegranate capsule contains 650mg of pomegranate extract (240 mg punicalagins and 350mg total biophenols) and the placebo, maltodextrin.

Participants will be required to attend the university clinic lab twice, having fasted overnight, with all measurements being taken pre and post study at 4 weeks. Blood, saliva and 24 hr urine samples will be provided. Body weight and composition, dietary habits and quality of life will also be measured. The well validated health related Quality of Life Questionnaire (Rand 36) will be administered pre- and post-intervention. This series of questions covers eight spheres of health. The physical health component considers physical functioning, physical role, bodily pain and general health. The mental health aspect examines vitality, social functioning, emotional role and general mental health. Anthropometric measurements recorded will be height, weight, waist, mid upper arm circumference. Bioelectrical impedance analysis (BIA), which measures conductivity from hand to foot, calculating both body fat and fat free mass, will also be performed.

Pre and post study comparison of the amount of polyphenols in 24 hr urine samples provided, alongside capsule consumption checks, will measure compliance. A 3 day diet diary record, will be used for recording energy intake and to highlight any fluctuations in dietary intake over the study period.

The data will be analysed using Statistical Programme for Social Sciences (SPSS) for Windows software version 19. Differences in baseline characteristics will be examined using independent t- tests with extract and placebo groups as independent variables and outcome measures as dependent variables. Paired t-tests will determine any individual differences between pre and post biochemical markers and anthropometric measurements. ANCOVAs will determine the overall differences between the independent groups.

This exploratory study will provide a foundation for and refine the outcome measures required for a larger future trial.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participants
  • BMI from 18-35
  • Males and Females
  • Age: 18-65 years

Exclusion Criteria:

Systemic disease, including heart disease and diabetes

  • Allergic reactions
  • Alcohol/drug abuse
  • Immunological conditions
  • Pregnancy or lactation
  • Liver and kidney disease
  • Management for weight control within the last 2 months
  • Heavy smokers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02005939

Locations
United Kingdom
Queen Margaret University
Edinburgh, Scotland, United Kingdom, EH21 6UU
Sponsors and Collaborators
Queen Margaret University
PomeGreat
Investigators
Study Director: Emad AS Al-Dujaili, Ph.D. Queen Margaret University
  More Information

No publications provided

Responsible Party: Angela Stockton, P.h.D. Researcher, Queen Margaret University
ClinicalTrials.gov Identifier: NCT02005939     History of Changes
Other Study ID Numbers: POM-01Expl, POM-01Expl
Study First Received: December 4, 2013
Last Updated: December 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Margaret University:
Pomegranate
Blood pressure
Insulin sensitivity
Cortisol
Quality of life
Body composition

ClinicalTrials.gov processed this record on April 21, 2014