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| Name | Class |
|---|---|
| Academy of Finland | OTHER |
| University of Oslo | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based food and fish with salt restr. | 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). |
|
| Diet with salt restriction | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effects of a Nordic diet rich in plant-based foods and fish | Other | The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in systolic and diastolic blood pressure after treatments | 12 and 20 weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iris Erlund, Dr. | Finnish Institute for Health and Welfare | Study Director |
| Antti Jula, Dr. | Finnish Institute for Health and Welfare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Health and Welfare | Helsinki | FI-00271 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36330564 | Derived | Niiranen T, Erlund I, Jalkanen S, Jula A, Salmi M. Effects of altered salt intake and diet on cytokines in humans: A 20-week randomized cross-over intervention study. Eur J Immunol. 2023 Jan;53(1):e2250074. doi: 10.1002/eji.202250074. Epub 2022 Nov 20. |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017404 | In Situ Hybridization, Fluorescence |
| ID | Term |
|---|---|
| D017403 | In Situ Hybridization |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
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| 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 |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D009693 | Nucleic Acid Hybridization |