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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Academy of Finland
University of Oslo
Information provided by (Responsible Party):
Iris Erlund, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01412346
First received: August 3, 2011
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

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).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute for Health and Welfare, Finland:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 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.
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).
 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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412346

Locations
Finland
National Institute for Health and Welfare
Helsinki, Finland, FI-00271
National Institute for Health and Welfare
Turku, Finland, FI-20720
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Academy of Finland
University of Oslo
Investigators
Study Director: Iris Erlund, Dr. National Institute for Health and Welfare, Finland
Study Director: Antti Jula, Dr. National Institute for Health and Welfare, Finland
  More Information

No publications provided

Responsible Party: Iris Erlund, PhD., senior researcher, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01412346     History of Changes
Other Study ID Numbers: NPHIKTL_022011
Study First Received: August 3, 2011
Last Updated: June 18, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by National Institute for Health and Welfare, Finland:
human
clinical trial
dietary intervention study
blood pressure
 cardiovascular biomarkers
nutritional biomarkers
gene expression

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013