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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01412346

Enrollment

111

Registered

2011-08-09

Start date

2011-01-31

Completion date

2014-09-30

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Prehypertension

Keywords

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

Brief 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).

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in systolic and diastolic blood pressure after treatments	12 and 20 weeks

Secondary

Measure	Time frame
Change from baseline in PFA-100 measurements after treatments	12 and 20 weeks
Change from baseline in biomarkers of cardiovascular disease risk after treatments	12 and 20 weeks
Change from baseline in nutritional biomarkers after treatments	12 and 20 weeks
Change from baseline in blood cell gene expression after treatments	12 and 20 weeks

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026