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

Tracking Information

First Received Date ^ICMJE

August 3, 2011

Last Updated Date

June 18, 2012

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in systolic and diastolic blood pressure after treatments [ Time Frame: 12 and 20 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01412346 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in PFA-100 measurements after treatments [ Time Frame: 12 and 20 weeks ] [ Designated as safety issue: No ]
Change from baseline in biomarkers of cardiovascular disease risk after treatments [ Time Frame: 12 and 20 weeks ] [ Designated as safety issue: No ]
Change from baseline in nutritional biomarkers after treatments [ Time Frame: 12 and 20 weeks ] [ Designated as safety issue: No ]
Change from baseline in blood cell gene expression after treatments [ Time Frame: 12 and 20 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Prehypertension
Hypertension

Intervention ^ICMJE

Other: 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.

Study Arms

Active Comparator: Plant-based food and fish with salt restriction
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).

Intervention: Other: Health effects of a Nordic diet rich in plant-based foods and fish
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).

Intervention: Other: Health effects of a Nordic diet rich in plant-based foods and fish

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

June 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01412346

Other Study ID Numbers ^ICMJE

NPHIKTL_022011

Has Data Monitoring Committee

Responsible Party

Iris Erlund, National Institute for Health and Welfare, Finland

Study Sponsor ^ICMJE

National Institute for Health and Welfare, Finland

Collaborators ^ICMJE

Academy of Finland
University of Oslo

Investigators ^ICMJE

Study Director:	Iris Erlund, Dr.	National Institute for Health and Welfare, Finland
Study Director:	Antti Jula, Dr.	National Institute for Health and Welfare, Finland

Information Provided By

National Institute for Health and Welfare, Finland

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP