Effects of a Nordic Diet on cardiovascular risk factors

ISRCTN	ISRCTN77759305
DOI	https://doi.org/10.1186/ISRCTN77759305
Secondary identifying numbers	U-07-009

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Ulf Riserus
Scientific

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

Study design	Randomised controlled parallel-group study with voluntary free-living subjects
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	Effects of a Nordic Diet on cardiovascular risk factors in hypercholesterolemic subjects: a randomised controlled trial
Study acronym	NORDIET
Study objectives	The aim of the study was to investigate the effects of a Nordic diet on cardiovascular risk factors in mildly hypercholesterolemic subjects.
Ethics approval(s)	Regional Ethics Committee in Uppsala approved on the 19th of December 2007 (ref: North D U-07-009 Dnr 2007/328)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/12/2007
Completion date	15/05/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	88
Key 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
Key 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
Date of first enrolment	20/12/2007
Date of final enrolment	15/05/2008

Clinical Nutrition and Metabolism

Uppsala
751 85
Sweden

University of Uppsala (Sweden)
University/education

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

Website	http://www.uu.se
"ROR"	https://ror.org/048a87296

Industry

The Cerealia Foundation R&D (Sweden)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan