The Effect of Kiwi on Blood Pressure, Endothelial Functio... | NCT00948363

Studies
The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression

NCT00948363

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jun 29, 2017Actual

Enrollment

118Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Kiwi fruits
Apple

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jul 27, 2009

First Submission Date that Met QC Criteria

Jul 28, 2009

First Posted Date

Jul 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2017

Last Update Posted Date

Jun 29, 2017Actual

Name	Class
University of Oslo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kiwi fruits	Active Comparator		Other: Kiwi fruits
Apple	Placebo Comparator		Other: Apple

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kiwi fruits	Other	Daily intake of 3 kiwi fruits for 8 weeks	Kiwi fruits

Measure	Description	Time Frame
Blood pressure		8 weeks

Measure	Description	Time Frame
Endothelial function		8 weeks

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Serena Tonstad, Professor	Preventive Cardiology, Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Preventive Cardiology		Oslo		0407	Norway
Oslo University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25483553	Derived	Svendsen M, Tonstad S, Heggen E, Pedersen TR, Seljeflot I, Bohn SK, Bastani NE, Blomhoff R, Holme IM, Klemsdal TO. The effect of kiwifruit consumption on blood pressure in subjects with moderately elevated blood pressure: a randomized, controlled study. Blood Press. 2015 Feb;24(1):48-54. doi: 10.3109/08037051.2014.976979. Epub 2014 Dec 8.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases