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

Sponsor

Finnish Institute for Health and Welfare (Other)

Overall Status

Completed

CT.gov ID

NCT01412346

Collaborator

Academy of Finland (Other), University of Oslo (Other)

111

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prehypertension Hypertension	Other: Effects of a Nordic diet rich in plant-based foods and fish	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in systolic and diastolic blood pressure after treatments [12 and 20 weeks]

Secondary Outcome Measures

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]