search
Back to results

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

Primary Purpose

Prehypertension, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Effects of a Nordic diet rich in plant-based foods and fish
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prehypertension focused on measuring human, clinical trial, dietary intervention study, blood pressure, cardiovascular biomarkers, nutritional biomarkers, gene expression

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Institute for Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Plant-based food and fish with salt restr.

Diet with salt restriction

Arm Description

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 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).

Outcomes

Primary Outcome Measures

Change from baseline in systolic and diastolic blood pressure after treatments

Secondary Outcome Measures

Change from baseline in PFA-100 measurements after treatments
Change from baseline in biomarkers of cardiovascular disease risk after treatments
Change from baseline in nutritional biomarkers after treatments
Change from baseline in blood cell gene expression after treatments

Full Information

First Posted
August 3, 2011
Last Updated
October 13, 2014
Sponsor
Finnish Institute for Health and Welfare
Collaborators
Academy of Finland, University of Oslo
search

1. Study Identification

Unique Protocol Identification Number
NCT01412346
Brief Title
Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish
Official Title
Health Effects of a Nordic Diet Rich in Plant-based Foods and Fish
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Finnish Institute for Health and Welfare
Collaborators
Academy of Finland, University of Oslo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension, Hypertension
Keywords
human, clinical trial, dietary intervention study, blood pressure, cardiovascular biomarkers, nutritional biomarkers, gene expression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plant-based food and fish with salt restr.
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Diet with salt restriction
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Effects of a Nordic diet rich in plant-based foods and fish
Intervention Description
The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.
Primary Outcome Measure Information:
Title
Change from baseline in systolic and diastolic blood pressure after treatments
Time Frame
12 and 20 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in PFA-100 measurements after treatments
Time Frame
12 and 20 weeks
Title
Change from baseline in biomarkers of cardiovascular disease risk after treatments
Time Frame
12 and 20 weeks
Title
Change from baseline in nutritional biomarkers after treatments
Time Frame
12 and 20 weeks
Title
Change from baseline in blood cell gene expression after treatments
Time Frame
12 and 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Erlund, Dr.
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antti Jula, Dr.
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
Facility Information:
Facility Name
National Institute for Health and Welfare
City
Helsinki
ZIP/Postal Code
FI-00271
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs