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

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

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.

Study Overview

• Status: Completed
• Conditions: Cholesterol, LDL
• Intervention / Treatment: Other: Written advice LDL Cholesterol; Other: Written advice Triglycerides

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Dalarna
    • Falun, Dalarna, Sweden, 79023
      • Svärdsjö Primary Health Care Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LDL Cholesterol; Will receive dietary advice effective for reducing LDL cholesterol.	Other: Written advice LDL Cholesterol; One A4 paper with written information on both sides; Other Names: Active Intervention
Sham Comparator: Triglycerides; 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; One A4 paper with written information on both sides; Other Names: Control Group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Dalarna County Council, Sweden
• Investigators: Principal Investigator: David Iggman, M.D. Ph.D, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Actual): April 18, 2019
• Study Completion (Actual): April 18, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Diet; cholesterol; Triglycerides; Food; LDL cholesterol; Lipoproteins
• Other Study ID Numbers: MYDICLIN; Dnr 2018/119 (Other Identifier: Uppsala Regional Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: N/A, data sharing is not included in Ethics application. Further consent from participants may be required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No