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

NCT01412346 | Completed

• 1 other identifier: NPHIKTL_022011
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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).

Conditions

Prehypertension; Hypertension

Keywords

human; clinical trial; dietary intervention study; blood pressure; cardiovascular biomarkers; nutritional biomarkers; gene expression

Outcome Measures

Primary Outcomes (1)

• Change from baseline in systolic and diastolic blood pressure after treatments

  12 and 20 weeks

Secondary Outcomes (4)

• Change from baseline in PFA-100 measurements after treatments

  12 and 20 weeks

• Change from baseline in biomarkers of cardiovascular disease risk after treatments

  12 and 20 weeks

• Change from baseline in nutritional biomarkers after treatments

  12 and 20 weeks

• Change from baseline in blood cell gene expression after treatments

  12 and 20 weeks

Study Arms (2)

Plant-based food and fish with salt restr.

ACTIVE COMPARATOR

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

Diet with salt restriction

PLACEBO COMPARATOR

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

Interventions

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

The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.

Diet with salt restriction; Plant-based food and fish with salt restr.

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prehypertension or hypertension (systolic blood pressure 130-159 mmHg or diastolic blood pressure 85-99 mmHg)

You may not qualify if:

• smoking
• regular use of medications
• intestinal disorders
• symptomatic cardiovascular disease
• obesity (BMI\>35 kg/m2)
• vegetarianism
• high intake of alcohol
• allergy to fish
• pregnancy

Sponsors & Collaborators

• Finnish Institute for Health and Welfare: lead
• Academy of Finland: collaborator
• University of Oslo: collaborator

Study Sites (1)

National Institute for Health and Welfare

Helsinki, FI-00271, Finland

Location

Related Publications (1)

• Niiranen T, Erlund I, Jalkanen S, Jula A, Salmi M. Effects of altered salt intake and diet on cytokines in humans: A 20-week randomized cross-over intervention study. Eur J Immunol. 2023 Jan;53(1):e2250074. doi: 10.1002/eji.202250074. Epub 2022 Nov 20.

  PMID: 36330564 DERIVED

MeSH Terms

Conditions

Prehypertension; Hypertension

Interventions

In Situ Hybridization, Fluorescence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization

Study Officials

• Iris Erlund, Dr.

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

• Antti Jula, Dr.

  Finnish Institute for Health and Welfare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD., senior researcher

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 9, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

FI (1)