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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by National Institute for Health and Welfare, Finland.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014