The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression - Full Text View

Sponsor:	Oslo University Hospital
Collaborator:	University of Oslo
Information provided by:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00948363

Purpose

The purpose of this study is to determine whether the intake of kiwi fruits will reduce systolic and diastolic blood pressure compared to intake of apples. The investigators hypothesize that the increased intake lutein or other components in the kiwi fruit will enhance nitric oxide bioavailability and lead to vascular relaxation.

Condition	Intervention
Hypertension	Other: Kiwi fruits Other: Apple

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression in Mildly Hypertensive Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Antioxidants High Blood Pressure

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:

Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endothelial function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	118
Study Start Date:	August 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Kiwi fruits	Other: Kiwi fruits Daily intake of 3 kiwi fruits for 8 weeks Other Name: Kiwi fruits
Placebo Comparator: Apple	Other: Apple Daily intake of 1 apple (equivalent in energy) for 8 weeks Other Name: Apple

Detailed Description:

An interesting finding in the Oslo Antioxidant Study was that intake of 3 kiwi fruits reduced blood pressure in a clinical significant manner compared to controls. The mechanism for the blood pressure reducing effect of kiwi or the responsible components are not elucidated. However, plasma lutein levels and antioxidant capacity measured by the ferric reducing antioxidant power was increased in the kiwi group. Moreover, gene expression was also altered by the increased intake of kiwi.

Eligibility

Ages Eligible for Study:	35 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Systolic blood pressure 130-159 mmHg
Diastolic blood pressure 85-99 mmHg
Body mass index <35 kg/m2

Exclusion Criteria:

Systolic blood pressure >160 mmHg or <129 mmHg
Diastolic blood pressure >100 mmHg or <84 mmHg
Current use or need for blood pressure lowering medication
Symptomatic cardiovascular disease, diabetes, renal dysfunction, psychiatric disorder, pregnancy or lactation, history of obesity surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948363

Locations

Norway
Department of Preventive Cardiology
Oslo, Norway, 0407
Oslo University Hospital
Oslo, Norway, 0407

Sponsors and Collaborators

Oslo University Hospital

University of Oslo

Investigators

Principal Investigator:

Serena Tonstad, Professor

Preventive Cardiology, Oslo University Hospital

More Information

No publications provided

Responsible Party:	Professor Serena Tonstad, Oslo University Hospital, Preventive Cardiology
ClinicalTrials.gov Identifier:	NCT00948363 History of Changes
Other Study ID Numbers:	1335
Study First Received:	July 27, 2009
Last Updated:	April 18, 2011
Health Authority:	Norway: Ethics Committee; Norway: Norwegian Institute of Public Health

Keywords provided by Oslo University Hospital:

Kiwi fruits
Blood pressure
Endothelial function
Antioxidant capacity

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antioxidants

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012