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

NCT01412346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2014-10-15

No results posted yet for this 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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Academy of Finland

    collaborator OTHER
  • University of Oslo

    collaborator OTHER
  • Finnish Institute for Health and Welfare

    lead OTHER_GOV

Principal Investigators

  • Iris Erlund, Dr. · Finnish Institute for Health and Welfare

  • Antti Jula, Dr. · Finnish Institute for Health and Welfare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-06-30
Completion
2014-09-30

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01412346 on ClinicalTrials.gov