Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial (MYDICLIN)

Conditions
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Cholesterol, LDL

Intervention / Treatment
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* Other: Written advice LDL Cholesterol
* Other: Written advice Triglycerides


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two identical parallel groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LDL Cholesterol<br>Will receive dietary advice effective for reducing LDL cholesterol. | Other: Written advice LDL Cholesterol<br>* One A4 paper with written information on both sides<br>* Other names: Active Intervention;|
| Sham Comparator: Triglycerides<br>Will not be aware that they are in fact Control Group. Will receive dietary advice effective for reducing Triglycerides, but neutral for LDL cholesterol. | Other: Written advice Triglycerides<br>* One A4 paper with written information on both sides<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL Cholesterol | Change in plasma LDL Cholesterol levels | 3 weeks and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol | Change in plasma Total Cholesterol levels | 3 weeks and 6 months | 
| HDL Cholesterol | Change in plasma HDL Cholesterol levels | 3 weeks and 6 months | 
| Apolipoproteins | Change in plasma Apolipoprotein levels | 3 weeks and 6 months | 
| Success rate | Percentage of participants that reduce LDL Cholesterol at least 10% | 3 weeks and 6 months | 
| Responder effect | Change in plasma LDL cholesterol after 6 months in participants that reduce LDL Cholesterol at least 10% at 3 weeks | 6 months and 3 weeks, respectively | 
| Double sampling requirement | Number of participants that would have been misclassified if not double sampling hade been performed for LDL cholesterol | 3 weeks and 6 months | 
| Cost of intervention | Cost of intervention, in comparison to possible health gains | 3 weeks and 6 months | 
| Effective food choices | Food choices that are in practice effective for lowering LDL cholesterol | 3 weeks and 6 months | 
| Stated reasons | Stated reasons for wanting to improve blood lipid profile and associations with effect on LDL Cholesterol | 3 weeks and 6 months | 
| PSCK9 | Change in serum PCSK9 levels | 3 weeks and 6 months | 
| Lipoprotein(a) | Change in plasma lipoprotein(a) levels | 3 weeks and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triglycerides, cholesterol, LDL cholesterol, Diet, Food, Lipoproteins