Condition category
Circulatory System
Date applied
24/11/2009
Date assigned
15/12/2009
Last edited
15/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ulf Riserus

ORCID ID

Contact details

Clinical Nutrition and Metabolism
Department of Public Health and Caring Sciences
Uppsala Science Park
Uppsala
751 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

U-07-009

Study information

Scientific title

Effects of a Nordic Diet on cardiovascular risk factors in hypercholesterolemic subjects: a randomised controlled trial

Acronym

NORDIET

Study hypothesis

The aim of the study was to investigate the effects of a Nordic diet on cardiovascular risk factors in mildly hypercholesterolemic subjects.

Ethics approval

Regional Ethics Committee in Uppsala approved on the 19th of December 2007 (ref: North D U-07-009 Dnr 2007/328)

Study design

Randomised controlled parallel-group study with voluntary free-living subjects

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Cardiovascular risk factors

Intervention

Intervention Group - The Nordic Diet:
The nutrient profile of the Nordic Diet (ND) was based on Nordic nutrition recommendations 200423 and inspired by the Mediterranean diet, Portfolio diet, DASH diet and NCEP. The food profile was based on typical foods consumed in the Nordic countries and the nutrient profile is comparable to that of the Mediterranean diet, including LDL-C lowering foods.

Control group - care as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in plasma LDL-C after 6 weeks

Secondary outcome measures

Change in:
1. Other blood lipids and apolipoproteins
2. Blood pressure
3. Insulin sensitivity (fasting insulin and homeostatic model assessment insulin resistance [HOMA-IR])

Overall trial start date

20/12/2007

Overall trial end date

15/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women between 25 and 65 years of age
2. Healthy as assessed by a physician
3. Body mass index (BMI) greater than or equal to 20 and less than or equal to 31 kg/m^2
4. Plasma low density lipoprotein cholesterol (LDL-C) greater than or equal to 3.5 mmol/l
5. Haemoglobin (Hb) greater than or equal to 120 g/l for women and greater than or equal to 130 g/l for men

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

88

Participant exclusion criteria

1. Participation in a clinical study within 90 days prior to screening visit and throughout the study
2. Use of lipid lowering drugs two months prior screening and throughout the study
3. Blood pressure greater than 145/85 mmHg
4. Use of products or supplements fortified with plant sterols, omega-3, omega-6 or omega-9 fatty acids within 3 weeks prior to baseline visit
5. Allergy to certain foods
6. Weight-loss diets or drugs
7. Special diets (e.g. vegan and gluten free)
8. Pregnant or lactating

Recruitment start date

20/12/2007

Recruitment end date

15/05/2008

Locations

Countries of recruitment

Sweden

Trial participating centre

Clinical Nutrition and Metabolism
Uppsala
751 85
Sweden

Sponsor information

Organisation

University of Uppsala (Sweden)

Sponsor details

Clinical Nutrition and Metabolism
Department of Public Health and Caring Sciences
Uppsala Science Park
Uppsala
751 85
Sweden

Sponsor type

University/education

Website

http://www.uu.se

Funders

Funder type

Industry

Funder name

The Cerealia Foundation R&D (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes