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

Cholesterol, LDL Clinical Trial

— MYDICLIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528252
• Other study ID #: MYDICLIN
• Secondary ID: Dnr 2018/119
• Status: Completed
• Phase: N/A
• Start date: May 16, 2018
• Est. completion date: April 18, 2019

Study information

• Verified date: April 2019
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: April 18, 2019
• Est. primary completion date: April 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholesterol, LDL

Intervention

Other:
• Written advice LDL Cholesterol
One A4 paper with written information on both sides
• Written advice Triglycerides
One A4 paper with written information on both sides

Locations

Country	Name	City	State
Sweden	Svärdsjö Primary Health Care Centre	Falun	Dalarna

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Dalarna County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL Cholesterol	Change in plasma LDL Cholesterol levels	3 weeks and 6 months
Secondary	Total Cholesterol	Change in plasma Total Cholesterol levels	3 weeks and 6 months
Secondary	HDL Cholesterol	Change in plasma HDL Cholesterol levels	3 weeks and 6 months
Secondary	Apolipoproteins	Change in plasma Apolipoprotein levels	3 weeks and 6 months
Secondary	Success rate	Percentage of participants that reduce LDL Cholesterol at least 10%	3 weeks and 6 months
Secondary	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
Secondary	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
Secondary	Cost of intervention	Cost of intervention, in comparison to possible health gains	3 weeks and 6 months
Secondary	Effective food choices	Food choices that are in practice effective for lowering LDL cholesterol	3 weeks and 6 months
Secondary	Stated reasons	Stated reasons for wanting to improve blood lipid profile and associations with effect on LDL Cholesterol	3 weeks and 6 months
Secondary	PSCK9	Change in serum PCSK9 levels	3 weeks and 6 months
Secondary	Lipoprotein(a)	Change in plasma lipoprotein(a) levels	3 weeks and 6 months