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

October 13, 2014 updated by: Iris Erlund, Finnish Institute for Health and Welfare

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.
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
The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Collaborators

University of Oslo
Academy of Finland

Investigators

  • Study Director: Antti Jula, Dr., Finnish Institute for Health and Welfare
  • Study Director: Iris Erlund, Dr., Finnish Institute for Health and Welfare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 8, 2011

First Posted (Estimate)

August 9, 2011

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 13, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPHIKTL_022011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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