NCT00948363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 29, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

July 27, 2009

Last Update Submit

June 28, 2017

Conditions

Hypertension

Keywords

Kiwi fruitsBlood pressureEndothelial functionAntioxidant capacity

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    8 weeks

Secondary Outcomes (1)

  • Endothelial function

    8 weeks

Study Arms (2)

Kiwi fruits

ACTIVE COMPARATOR
Other: Kiwi fruits

Apple

PLACEBO COMPARATOR
Other: Apple

Interventions

Kiwi fruitsOTHER

Daily intake of 3 kiwi fruits for 8 weeks

Kiwi fruits
AppleOTHER

Daily intake of 1 apple (equivalent in energy) for 8 weeks

Apple

Eligibility Criteria

Age35 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Preventive Cardiology

Oslo, 0407, Norway

Location

Oslo University Hospital

Oslo, 0407, Norway

Location

Related Publications (1)

  • 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.

    PMID: 25483553DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Serena Tonstad, Professor

    Preventive Cardiology, Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Consultant

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 29, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 29, 2017

Record last verified: 2017-06

Locations

NO(2)