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

Study Overview
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Brief Summary
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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).

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

Conditions
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Prehypertension, Hypertension

Intervention / Treatment
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* Other: Effects of a Nordic diet rich in plant-based foods and fish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plant-based food and fish with salt restr.<br>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<br>* The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.<br>|
| Placebo Comparator: Diet with salt restriction<br>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<br>* The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic and diastolic blood pressure after treatments |  | 12 and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human, clinical trial, dietary intervention study, blood pressure, cardiovascular biomarkers, nutritional biomarkers, gene expression