- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01412346
Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, FI-00271
- National Institute for Health and Welfare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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).
|
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).
|
The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction.
Key foods are provided to the subjects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in systolic and diastolic blood pressure after treatments
Time Frame: 12 and 20 weeks
|
12 and 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in PFA-100 measurements after treatments
Time Frame: 12 and 20 weeks
|
12 and 20 weeks
|
Change from baseline in biomarkers of cardiovascular disease risk after treatments
Time Frame: 12 and 20 weeks
|
12 and 20 weeks
|
Change from baseline in nutritional biomarkers after treatments
Time Frame: 12 and 20 weeks
|
12 and 20 weeks
|
Change from baseline in blood cell gene expression after treatments
Time Frame: 12 and 20 weeks
|
12 and 20 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Antti Jula, Dr., Finnish Institute for Health and Welfare
- Study Director: Iris Erlund, Dr., Finnish Institute for Health and Welfare
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPHIKTL_022011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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