Cholesterol, LDL
Conditions
Keywords
cholesterol, LDL cholesterol, Triglycerides, Diet, Food, Lipoproteins
Brief summary
This study investigates the effect of detailed, written dietary advice for improving blood lipids, in a primary care setting. n=222 participants will be randomized to Active Intervention or Control Group. After 3 weeks' intervention, participants will receive written feedback on the effect on their blood lipids. After 6 months, another blood sample is drawn and participants will receive further written feedback.
Detailed description
The Active Intervention Group will receive detailed dietary advice based on current evidence for food choices that improve LDL cholesterol levels. The information will contain motivational strategies, e.g. It's great that you want to improve your blood lipids! What are your three main reasons that you want to improve your blood lipids? What food choices suit you? How low can you go? Participants will receive a table of ten suggested healthy food choices and be instructed to mark for each day a certain food change has been made. The Control Group will receive similar advice and motivational strategies, with the one difference being the dietary advice, that will focus on Triglycerides instead of LDL cholesterol.
Interventions
OTHERWritten advice LDL Cholesterol
One A4 paper with written information on both sides
OTHERWritten advice Triglycerides
One A4 paper with written information on both sides
Sponsors
Dalarna County Council, Sweden
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Randomization by sealed envelopes, opened in private. Allocation sequence and envelopes provided by external agent. Participants are instructed not to discuss intervention outside household. No more than one (randomly selected) participant per household allowed.
Intervention model description
Two identical parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Listed patient at Svärdsjö Primary Health Care Centre * Willing to reduce blood lipids
Exclusion criteria
* Drugs affecting blood lipids (statins, ezetimibe, fibrates, PCSK9-inhibitors, neuroleptic drugs, cortisone, amiodarone, estrogen, progesterone, testosterone, cyclosporin, tacrolimus, loop diuretics, protease inhibitors and anti-convulsants; whereas beta blockers, thiazide diuretics, and SGLT2-inhibitors are allowed under established medication * Current malignant disease * Extreme diet * Abnormal metabolism e.g. uncontrolled hypothyroidism * Dementia * Unability to comprehend written information in Swedish * Other participant from same household * Current employment on Svärdsjö Primary Health Care Centre
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL Cholesterol | 3 weeks and 6 months | Change in plasma LDL Cholesterol levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HDL Cholesterol | 3 weeks and 6 months | Change in plasma HDL Cholesterol levels |
| Apolipoproteins | 3 weeks and 6 months | Change in plasma Apolipoprotein levels |
| Success rate | 3 weeks and 6 months | Percentage of participants that reduce LDL Cholesterol at least 10% |
| Responder effect | 6 months and 3 weeks, respectively | Change in plasma LDL cholesterol after 6 months in participants that reduce LDL Cholesterol at least 10% at 3 weeks |
| Double sampling requirement | 3 weeks and 6 months | Number of participants that would have been misclassified if not double sampling hade been performed for LDL cholesterol |
| Total Cholesterol | 3 weeks and 6 months | Change in plasma Total Cholesterol levels |
| Effective food choices | 3 weeks and 6 months | Food choices that are in practice effective for lowering LDL cholesterol |
| Stated reasons | 3 weeks and 6 months | Stated reasons for wanting to improve blood lipid profile and associations with effect on LDL Cholesterol |
| PSCK9 | 3 weeks and 6 months | Change in serum PCSK9 levels |
| Lipoprotein(a) | 3 weeks and 6 months | Change in plasma lipoprotein(a) levels |
| Cost of intervention | 3 weeks and 6 months | Cost of intervention, in comparison to possible health gains |
Countries
Sweden
Outcome results
None listed