Overview

This trial is active, not recruiting.

Conditions prehypertension, hypertension
Treatment health effects of a nordic diet rich in plant-based foods and fish
Sponsor National Institute for Health and Welfare, Finland
Collaborator Academy of Finland
Start date January 2011
End date June 2012
Trial size 120 participants
Trial identifier NCT01412346, NPHIKTL_022011

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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).
health 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)
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).
health 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.

Primary Outcomes

Measure
Change from baseline in systolic and diastolic blood pressure after treatments
time frame: 12 and 20 weeks

Secondary Outcomes

Measure
Change from baseline in PFA-100 measurements after treatments
time frame: 12 and 20 weeks
Change from baseline in biomarkers of cardiovascular disease risk after treatments
time frame: 12 and 20 weeks
Change from baseline in nutritional biomarkers after treatments
time frame: 12 and 20 weeks
Change from baseline in blood cell gene expression after treatments
time frame: 12 and 20 weeks

Eligibility Criteria

Male or female participants from 45 years up to 75 years old.

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

Additional Information

Official title Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by National Institute for Health and Welfare, Finland.