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CompletedNCT01412346Updated Oct 15, 2014

Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish

An interventional study of Effects of a Nordic diet rich in plant-based foods and fish in Prehypertension and Hypertension, sponsored by Finnish Institute for Health and Welfare. Completed at 1 site in Finland. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-15.

Sponsored by Finnish Institute for Health and Welfare · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Prehypertension
  • Hypertension

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Keywords

  • human
  • clinical trial
  • dietary intervention study
  • blood pressure
  • cardiovascular biomarkers
  • nutritional biomarkers
  • gene expression
03

In context

Prehypertension

145 studies on the registry are indexed under Prehypertension; 21 are open to participants now.

This study's enrollment of 111 is above the median of 62 across 127 interventional studies indexed under Prehypertension.

Browse Prehypertension studies →

Lead sponsor

Finnish Institute for Health and Welfare is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • prehypertension or hypertension (systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg)

Exclusion criteria

Exclusion Criteria:

  • smoking
  • regular use of medications
  • intestinal disorders
  • symptomatic cardiovascular disease
  • obesity (BMI>35 kg/m2)
  • vegetarianism
  • high intake of alcohol
  • allergy to fish
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
111 participants (actual)

Study arms

  • Active comparator
    Plant-based food and fish with salt restr.

    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).

    Other: Effects of a Nordic diet rich in plant-based foods and fish

  • Placebo comparator
    Diet with salt restriction

    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).

    Other: Effects of a Nordic diet rich in plant-based foods and fish

Interventions

  • OtherEffects of a Nordic diet rich in plant-based foods and fish

    The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.

06

What researchers measure

Primary outcomes

  1. Change from baseline in systolic and diastolic blood pressure after treatments

    Time frame: 12 and 20 weeks

Secondary outcomes

  1. Change from baseline in PFA-100 measurements after treatments

    Time frame: 12 and 20 weeks

  2. Change from baseline in biomarkers of cardiovascular disease risk after treatments

    Time frame: 12 and 20 weeks

  3. Change from baseline in nutritional biomarkers after treatments

    Time frame: 12 and 20 weeks

  4. Change from baseline in blood cell gene expression after treatments

    Time frame: 12 and 20 weeks

07

Study locations

1 site
  • National Institute for Health and Welfare
    Helsinki, FI-00271, Finland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01412346
Lead sponsor
Finnish Institute for Health and Welfare
Collaborators
Academy of Finland, University of Oslo
Responsible party
Iris Erlund (PhD., senior researcher, Finnish Institute for Health and Welfare) — Principal investigator
First posted
Aug 9, 2011
Start date
Jan 2011
Primary completion
Jun 2012
Completion
Sep 2014
Last update
Oct 15, 2014

Study contacts

Iris Erlund, Dr.
study director · Finnish Institute for Health and Welfare
Antti Jula, Dr.
study director · Finnish Institute for Health and Welfare

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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