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NCT Number: NCT01412346

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

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).

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Key information

Conditions

Prehypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Health and Welfare

Helsinki, FI-00271, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

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

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

  • Academy of Finland
  • University of Oslo

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Aug 9, 2011
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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