Effects of a Nordic Diet on cardiovascular risk factors
| ISRCTN | ISRCTN77759305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77759305 |
| Protocol serial number | U-07-009 |
| Sponsor | University of Uppsala (Sweden) |
| Funder | The Cerealia Foundation R&D (Sweden) |
- Submission date
- 24/11/2009
- Registration date
- 15/12/2009
- Last edited
- 15/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Prof Ulf Riserus
Scientific
Scientific
Clinical Nutrition and Metabolism
Department of Public Health and Caring Sciences
Uppsala Science Park
Uppsala
751 85
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled parallel-group study with voluntary free-living subjects |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Change in plasma LDL-C after 6 weeks |
| Key secondary outcome measure(s) |
Change in: |
| Completion date | 15/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Clinical Nutrition and Metabolism
Uppsala
751 85
Sweden
751 85
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
