Effects of a Nordic breakfast on cardiovascular risk factors.
| ISRCTN | ISRCTN84550872 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84550872 |
| Secondary identifying numbers | North B U-08-017 |
- 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
| Study design | Randomised controlled parallel group intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | The effect on LDL-cholesterol will be measured at baseline, 6 and 12 weeks. |
| Secondary outcome measures | The following will be measured at baseline, 6 and 12 weeks 1. HDL cholesterol 2. Total cholesterol 3. Triglycerides 4. High-Sensitivity C-Reactive Protein (HS-CRP) 5. Apolipoprotein A1 and B 6. Blood pressure 7. Sagittal abdominal diameter (SAG) 8. Hip 9. Waist 10. Glycated Haemoglobin (HbA1c) The following will be measured at baseline and 12 weeks 11. Glucose response 12. Insulin sensitivity |
| Overall study start date | 01/06/2009 |
| Completion date | 30/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
University of Uppsala (Sweden)
University/education
University/education
Clinical Nutrition and Metabolism
Departement of Public health and Caring Sciences
Uppsala Science Park
Uppsala
751 85
Sweden
"ROR" |
https://ror.org/048a87296 |
|---|
Funders
Funder type
Industry
Cerealia Foundation R&D (Sweden)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | Yes | No |
