Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/12/2009
Date assigned
07/01/2010
Last edited
14/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ulf Riserus

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

University of Uppsala (Sweden)

Sponsor details

Clinical Nutrition and Metabolism
Departement of Public health and Caring Sciences
Uppsala Science Park
Uppsala
751 85
Sweden

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24814382

Publication citations

  1. 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.

Additional files

Editorial Notes