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

Finnish Institute for Health and Welfare

Status: Completed

Conditions: Hypertension; Prehypertension

Treatments: Other: Effects of a Nordic diet rich in plant-based foods and fish

Study type: Interventional

Funder types: Other

Identifiers

NCT01412346

NPHIKTL_022011

Details and patient eligibility

About

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).

Enrollment: 111 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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111 participants in 2 patient groups, including a placebo group

Plant-based food and fish with salt restr.

Active Comparator group

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).

Treatment:

Other: Effects of a Nordic diet rich in plant-based foods and fish

Diet with salt restriction

Placebo Comparator group

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).

Treatment:

Other: Effects of a Nordic diet rich in plant-based foods and fish