Effects of a Nordic breakfast on cardiovascular risk factors.
| ISRCTN | ISRCTN84550872 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84550872 |
| Protocol serial number | North B U-08-017 |
| Sponsor | University of Uppsala (Sweden) |
| Funder | Cerealia Foundation R&D (Sweden) |
- Submission date
- 04/12/2009
- Registration date
- 07/01/2010
- Last edited
- 14/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr 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 intervention study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of a Nordic breakfast diet on risk markers for cardiovascular disease in healthy mildly hypercholesterolemic men and women. |
| Study acronym | North B |
| Study objectives | The aim of this study is to investigate if intake of a healthy Nordic breakfast may affect risk markers for cardiovascular disease in healthy mildly hypercholesterolemic men and women. |
| Ethics approval(s) | The study was approved by the regional ethic committee in Uppsala, on the 20th of January 2009 (ref: North B U-08-017, Dnr 2009/018) |
| Health condition(s) or problem(s) studied | Cardiovascular risk factors |
| Intervention | The test breakfast will include: Porridge made of oat bran. Low fat milk or yoghurt. A choice of jam (blueberries or lingonberries). Whole grain bread. Margarine with high content of polyunsaturated fatty acids (19%). Something to put on the bread such as low fat meat or pickled herring or mackerel in tomato. Fresh fruit will also be included. Outcomes after intake of a Nordic breakfast diet in comparison to ordinary foods in mildly hypercholesterolemic men and women, (LDL-cholesterol levels > 3.0 mmol/l) will be measured after 12 weeks. There will be no follow up beyond the end of the 12 week intervention. |
| Intervention type | Other |
| Primary outcome measure(s) |
The effect on LDL-cholesterol will be measured at baseline, 6 and 12 weeks. |
| Key secondary outcome measure(s) |
The following will be measured at baseline, 6 and 12 weeks |
| Completion date | 30/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 88 |
| Key inclusion criteria | 1. Slightly overweight and hyperlipidemic but otherwise healthy as assessed by the results of the screening laboratory tests and judged by medical staff 2. Age ≥ 25 and ≤ 67 years at visit 1 3. Body Mass Index (BMI) ≥ 25 and ≤ 35 kg/m2 4. LDL cholesterol ≥ 3.0 mmol/l 5. Haemoglobin (Hb) ≥ 120 g/l for women and ≥ 130 g/l for men 6. Signed written informed and biobank consents |
| Key exclusion criteria | 1. Participation in a clinical study with blood sampling within 90 days prior to screening visit and throughout the study. 2. Use of cholesterol lowering medication <3 months prior screening visit. 3. Blood pressure >155/95 (will be measured at visit 1 for inclusion). 4. Consumption of products or supplements fortified with plant sterols or omega-3 or omega-6 or omega 9- fatty acids within 3 weeks prior to the visit 1 and no consumption at all throughout the study. 5. Allergic to certain foods 6. Slimming or medically prescribed diet/medication or a special diet (vegan and gluten-free). 7. Not able to eat porridge for breakfast every day during 12 weeks 8. Not able to eat herring or mackerel for breakfast 3 days/week during 12 weeks 9. Pregnant or lactating or wish to become pregnant during the period of the study. 10. Lack of suitability for participation in the study for any reason as judged by the personnel at Good Food Practice (GFP) research clinic. |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 30/01/2010 |
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
