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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412346
• Other study ID #: NPHIKTL_022011
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: October 13, 2014
• Start date: January 2011
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: September 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

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.

Locations

Country	Name	City	State
Finland	National Institute for Health and Welfare	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Academy of Finland, University of Oslo

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in systolic and diastolic blood pressure after treatments		12 and 20 weeks	No
Secondary	Change from baseline in PFA-100 measurements after treatments		12 and 20 weeks	No
Secondary	Change from baseline in biomarkers of cardiovascular disease risk after treatments		12 and 20 weeks	No
Secondary	Change from baseline in nutritional biomarkers after treatments		12 and 20 weeks	No
Secondary	Change from baseline in blood cell gene expression after treatments		12 and 20 weeks	No