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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528252
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Dalarna County Council, Sweden
Information provided by (Responsible Party):
David Iggman, Uppsala University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cholesterol, LDL Other: Written advice LDL Cholesterol Other: Written advice Triglycerides Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two identical parallel groups
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Prevention
Official Title: Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial (MYDICLIN)
Actual Study Start Date : May 16, 2018
Actual Primary Completion Date : April 18, 2019
Actual Study Completion Date : April 18, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Control Group


Outcome Measures
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Primary Outcome Measures :
  1. LDL Cholesterol [ Time Frame: 3 weeks and 6 months ]
    Change in plasma LDL Cholesterol levels


Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: 3 weeks and 6 months ]
    Change in plasma Total Cholesterol levels

  2. HDL Cholesterol [ Time Frame: 3 weeks and 6 months ]
    Change in plasma HDL Cholesterol levels

  3. Apolipoproteins [ Time Frame: 3 weeks and 6 months ]
    Change in plasma Apolipoprotein levels

  4. Success rate [ Time Frame: 3 weeks and 6 months ]
    Percentage of participants that reduce LDL Cholesterol at least 10%

  5. Responder effect [ Time Frame: 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

  6. Double sampling requirement [ Time Frame: 3 weeks and 6 months ]
    Number of participants that would have been misclassified if not double sampling hade been performed for LDL cholesterol

  7. Cost of intervention [ Time Frame: 3 weeks and 6 months ]
    Cost of intervention, in comparison to possible health gains

  8. Effective food choices [ Time Frame: 3 weeks and 6 months ]
    Food choices that are in practice effective for lowering LDL cholesterol

  9. Stated reasons [ Time Frame: 3 weeks and 6 months ]
    Stated reasons for wanting to improve blood lipid profile and associations with effect on LDL Cholesterol

  10. PSCK9 [ Time Frame: 3 weeks and 6 months ]
    Change in serum PCSK9 levels

  11. Lipoprotein(a) [ Time Frame: 3 weeks and 6 months ]
    Change in plasma lipoprotein(a) levels


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528252


Locations
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Sweden
Svärdsjö Primary Health Care Centre
Falun, Dalarna, Sweden, 79023
Sponsors and Collaborators
Uppsala University
Dalarna County Council, Sweden
Investigators
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Principal Investigator: David Iggman, M.D. Ph.D Uppsala University
  Study Documents (Full-Text)

Documents provided by David Iggman, Uppsala University:
Statistical Analysis Plan  [PDF] April 18, 2019
Study Protocol  [PDF] April 23, 2019

More Information
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Responsible Party: David Iggman, General practitioner, Principal Investigator, Associated researcher, Uppsala University
ClinicalTrials.gov Identifier: NCT03528252    
Other Study ID Numbers: MYDICLIN
Dnr 2018/119 ( Other Identifier: Uppsala Regional Ethics Committee )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A, data sharing is not included in Ethics application. Further consent from participants may be required.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Iggman, Uppsala University:
cholesterol
LDL cholesterol
Triglycerides
 Diet
Food
Lipoproteins