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

Not Applicable

Completed

• Conditions: Prehypertension; Hypertension
• Interventions: Other: Effects of a Nordic diet rich in plant-based foods and fish

• Registration Number: NCT01412346
• Lead Sponsor: Finnish Institute for Health and Welfare

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Primary Completion: 2012-06
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-13
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Plant-based food and fish with salt restr.	Effects of a Nordic diet rich in plant-based foods and fish	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).
Diet with salt restriction	Effects of a Nordic diet rich in plant-based foods and fish	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).

Primary Outcome Measures

Name	Time	Method
Change from baseline in systolic and diastolic blood pressure after treatments	12 and 20 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Institute for Health and Welfare; 🇫🇮 Helsinki, Finland