- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948363
The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression
June 28, 2017 updated by: Tor Ole Klemsdal, Oslo University Hospital
The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression in Mildly Hypertensive Subjects
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Oslo, Norway, 0407
- Oslo University Hospital
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Oslo, Norway, 0407
- Department of Preventive Cardiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Kiwi fruits
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Daily intake of 3 kiwi fruits for 8 weeks
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Placebo Comparator: Apple
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Daily intake of 1 apple (equivalent in energy) for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood pressure
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Endothelial function
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Serena Tonstad, Professor, Preventive Cardiology, Oslo University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
July 27, 2009
First Submitted That Met QC Criteria
July 28, 2009
First Posted (Estimate)
July 29, 2009
Study Record Updates
Last Update Posted (Actual)
June 29, 2017
Last Update Submitted That Met QC Criteria
June 28, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1335
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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