PrehypertensionNCT01412346
Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish
A study testing Effects of a Nordic diet rich in plant-based foods and fish in people with Prehypertension and Hypertension, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
The purpose of this study is to investigate the effects of a Nordic diet rich in plant-based foods and fish on indicators of cardiovascular disease risk at two different levels of salt intake. The study is a 20-wk randomized controlled crossover trial. The subjects follow a salt-restricted diet during the study. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension, Hypertension
- What is being tested?
- Effects of a Nordic diet rich in plant-based foods and fish
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Sep 2014
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- prehypertension or hypertension (systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg)
Who cannot join
- smoking
- regular use of medications
- intestinal disorders
- symptomatic cardiovascular disease
- obesity (BMI>35 kg/m2)
- vegetarianism
Show all 9Show fewer
- high intake of alcohol
- allergy to fish
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of a Nordic diet rich in plant-based foods and fish on indicators of cardiovascular disease risk at two different levels of salt intake.
The study is a 20-wk randomized controlled crossover trial. The subjects follow a salt-restricted diet during the study. The study begins with a 4-wk run-in phase for all subjects. After that the subjects are randomly allocated to one of two groups. Group 1 consumes a healthy Nordic low-salt diet enriched with plant-based foods and fish for 16 weeks. Group 2 consumes a low-salt diet for 16 weeks. During the 16 weeks, both groups receive salt and placebo capsules in a double-blind, crossover fashion (8+8 weeks).
- Conditions
- Prehypertension, Hypertension
- Being tested
- Effects of a Nordic diet rich in plant-based foods and fish
- Keywords
- human, clinical trial, dietary intervention study, blood pressure, cardiovascular biomarkers, nutritional biomarkers, gene expression
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of a Nordic diet rich in plant-based foods and fishOther
The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Plant-based food and fish with salt restr. | Active comparator | The subjects consume plant based foods (fruits, berries, vegetables, whole grain) and fish in addition to a salt-restricted diet. Intake of salt is normal to high for 8 weeks and low for 8 weeks (subjects receive salt and placebo capsules in a crossover design). Receives: Other: Effects of a Nordic diet rich in plant-based foods and fish |
| Diet with salt restriction | Placebo comparator | The subjects follow a salt-restricted diet. Intake of salt is normal to high for 8 weeks and low for 8 weeks (subjects receive salt and placebo capsules in a crossover design). Receives: Other: Effects of a Nordic diet rich in plant-based foods and fish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in systolic and diastolic blood pressure after treatments
Measured: 12 and 20 weeks
Secondary outcomes (4)
Change from baseline in PFA-100 measurements after treatments
Measured: 12 and 20 weeks
Change from baseline in biomarkers of cardiovascular disease risk after treatments
Measured: 12 and 20 weeks
Change from baseline in nutritional biomarkers after treatments
Measured: 12 and 20 weeks
Change from baseline in blood cell gene expression after treatments
Measured: 12 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionSep 2014
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 PrehypertensionStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Academy of Finland, University of Oslo
- Responsible party
- Principal investigator, Iris Erlund, Finnish Institute for Health and Welfare
- Investigators
- Iris Erlund, Dr., Study director, Finnish Institute for Health and WelfareAntti Jula, Dr., Study director, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412346
- Sponsor's protocol ID
- NPHIKTL_022011
- Status last verified
- Oct 2014
- First submitted
- 3 Aug 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Niiranen T, Erlund I, Jalkanen S, Jula A, Salmi M. Effects of altered salt intake and diet on cytokines in humans: A 20-week randomized cross-over intervention study. Eur J Immunol. 2023 Jan;53(1):e2250074. doi: 10.1002/eji.202250074. Epub 2022 Nov 20.
PubMed 36330564
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish
- ClinicalTrials.gov ID
- NCT01412346
- Acronym / sponsor ID
- NPHIKTL_022011
- Conditions
- Prehypertension, Hypertension
- Keywords
- human, clinical trial, dietary intervention study, blood pressure, cardiovascular biomarkers, nutritional biomarkers, gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Academy of Finland, University of Oslo
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Aug 2011 (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 investigate the effects of a Nordic diet rich in plant-based foods and fish on indicators of cardiovascular disease risk at two different levels of salt intake.
The study is a 20-wk randomized controlled crossover trial. The subjects follow a salt-restricted diet during the study. The study begins with a 4-wk run-in phase for all subjects. After that the subjects are randomly allocated to one of two groups. Group 1 consumes a healthy Nordic low-salt diet enriched with plant-based foods and fish for 16 weeks. Group 2 consumes a low-salt diet for 16 weeks. During the 16 weeks, both groups receive salt and placebo capsules in a double-blind, crossover fashion (8+8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant-based food and fish with salt restr. | Active comparator | Other: Effects of a Nordic diet rich in plant-based foods and fishThe subjects consume plant based foods (fruits, berries, vegetables, whole grain) and fish in addition to a salt-restricted diet. Intake of salt is normal to high for 8 weeks and low for 8 weeks (subjects receive salt and placebo capsules in a crossover design). |
| Diet with salt restriction | Placebo comparator | Other: Effects of a Nordic diet rich in plant-based foods and fishThe subjects follow a salt-restricted diet. Intake of salt is normal to high for 8 weeks and low for 8 weeks (subjects receive salt and placebo capsules in a crossover design). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- prehypertension or hypertension (systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg)
Key exclusion criteria (9 listed)
- smoking
- regular use of medications
- intestinal disorders
- symptomatic cardiovascular disease
- obesity (BMI>35 kg/m2)
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 |
|---|---|---|
| Effects of a Nordic diet rich in plant-based foods and fishThe intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects. | Other | Diet with salt restriction, Plant-based food and fish with salt restr. |
Primary outcome
Change from baseline in systolic and diastolic blood pressure after treatments
Time frame: 12 and 20 weeks
4 secondary outcomes
Change from baseline in PFA-100 measurements after treatments
Time frame: 12 and 20 weeks
Change from baseline in biomarkers of cardiovascular disease risk after treatments
Time frame: 12 and 20 weeks
Change from baseline in nutritional biomarkers after treatments
Time frame: 12 and 20 weeks
Change from baseline in blood cell gene expression after treatments
Time frame: 12 and 20 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 15 Oct 2014.
- Derived from this study: PubMed 36330564Niiranen T, Erlund I, Jalkanen S, Jula A, Salmi M. Effects of altered salt intake and diet on cytokines in humans: A 20-week randomized cross-over intervention study. Eur J Immunol. 2023 Jan;53(1):e2250074. doi: 10.1002/eji.202250074. Epub 2022 Nov 20.
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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.
Iris Erlund, Dr. study director
Finnish Institute for Health and Welfare
Antti Jula, Dr. study director
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effects of a Nordic diet rich in plant-based foods and fish in people with Prehypertension and Hypertension, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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 1 inclusion and 9 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
Change from baseline in systolic and diastolic blood pressure after treatments (time frame: 12 and 20 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 NCT01412346, 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 15 Oct 2014.