HypertensionNCT00948363
The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression
A study testing Kiwi fruits and Apple in people with Hypertension, run by Oslo University Hospital at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Kiwi fruits and Apple
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systolic blood pressure 130-159 mmHg
- Diastolic blood pressure 85-99 mmHg
- Body mass index <35 kg/m2
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Preventive Cardiology
Oslo, 0407
Oslo University Hospital
Oslo, 0407
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Kiwi fruits, Apple
- Keywords
- Kiwi fruits, Blood pressure, Endothelial function, Antioxidant capacity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kiwi fruitsOther
Daily intake of 3 kiwi fruits for 8 weeks
AppleOther
Daily intake of 1 apple (equivalent in energy) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Kiwi fruits | Active comparator | Not described Receives: Other: Kiwi fruits |
| Apple | Placebo comparator | Not described Receives: Other: Apple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 8 weeks
Secondary outcomes (1)
Endothelial function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Tor Ole Klemsdal, Oslo University Hospital
- Investigators
- Serena Tonstad, Professor, Principal investigator, Preventive Cardiology, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948363
- Sponsor's protocol ID
- 1335
- Status last verified
- Jun 2017
- First submitted
- 27 Jul 2009
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25483553
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kiwi on Blood Pressure, Endothelial Function, Antioxidant Capacity and Gene Expression in Mildly Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT00948363
- Acronym / sponsor ID
- 1335
- Conditions
- Hypertension
- Keywords
- Kiwi fruits, Blood pressure, Endothelial function, Antioxidant capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kiwi fruits | Active comparator | Other: Kiwi fruits |
| Apple | Placebo comparator | Other: Apple |
Who may qualify
- Ages
- 35 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Systolic blood pressure 130-159 mmHg
- Diastolic blood pressure 85-99 mmHg
- Body mass index <35 kg/m2
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kiwi fruitsDaily intake of 3 kiwi fruits for 8 weeks | Other | Kiwi fruits |
| AppleDaily intake of 1 apple (equivalent in energy) for 8 weeks | Other | Apple |
Primary outcome
Blood pressure
Time frame: 8 weeks
1 secondary outcome
Endothelial function
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Derived from this study: PubMed 25483553Svendsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serena Tonstad, Professor principal investigator
Preventive Cardiology, Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kiwi fruits and Apple in people with Hypertension, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.