Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
North B U-08-017
Study information
Scientific title
Effects of a Nordic breakfast diet on risk markers for cardiovascular disease in healthy mildly hypercholesterolemic men and women.
Acronym
North B
Study hypothesis
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
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)
Study design
Randomised controlled parallel group intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/06/2009
Overall trial end date
30/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
88
Participant 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.
Recruitment start date
01/06/2009
Recruitment end date
30/01/2010
Locations
Countries of recruitment
Sweden
Trial participating centre
Clinical Nutrition and Metabolism
Uppsala
751 85
Sweden
Funders
Funder type
Industry
Funder name
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24814382
Publication citations
-
Results
Adamsson V, Reumark A, Marklund M, Larsson A, Risérus U, Role of a prudent breakfast in improving cardiometabolic risk factors in subjects with hypercholesterolemia: A randomized controlled trial., Clin Nutr, 2014, doi: 10.1016/j.clnu.2014.04.009.