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

NCT02005939 | Completed DMC

• 1 other identifier: POM-01Expl
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Risk Factors

Keywords

Pomegranate; Blood pressure; Insulin sensitivity; Cortisol; Quality of life; Body composition

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Change in systolic and diastolic blood pressure

  Week 0, 4

Secondary Outcomes (1)

• Changes in insulin sensitivity

  Week 0, 4

Other Outcomes (3)

• stress hormone levels

  Week 0, 4

• Changes in body composition

  week 0, 4

• Quality of Life

  Week 0, 4

Study Arms (2)

Pomegranate extract capsule

EXPERIMENTAL

All participants receive 1.1 g pomegranate extract capsule daily for 4 weeks

Dietary Supplement: Pomegranate extract

Placebo capsule

PLACEBO COMPARATOR

All participants receive a 1.1g placebo capsule daily for 4 weeks

Interventions

Pomegranate extract DIETARY_SUPPLEMENT

All randomised participants to the intervention arm receive one pomegranate capsule daily for 4 weeks

Also known as: Pomegreat PurePlus

Pomegranate extract capsule

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Margaret University: lead
• PomeGreat: collaborator

Study Sites (1)

Queen Margaret University

Edinburgh, Scotland, EH21 6UU, United Kingdom

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

pomegranate fruit rind

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Emad AS Al-Dujaili, Ph.D.

  Queen Margaret University

  STUDY DIRECTOR

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: P.h.D. Researcher

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: April 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

GB (1)