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NCT Number: NCT03528252

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

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.

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Key information

Conditions

Cholesterol, LDL

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Svärdsjö Primary Health Care Centre

Falun, Dalarna County, 79023, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written advice LDL Cholesterol

Other

One A4 paper with written information on both sides

Other names: Active Intervention

Written advice Triglycerides

Other

One A4 paper with written information on both sides

Other names: Control Group

Primary outcomes

  1. LDL Cholesterol

    Time frame: 3 weeks and 6 months

    Change in plasma LDL Cholesterol levels

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Dalarna County Council, Sweden

Registry information

Official study title

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

Acronym: MYDICLIN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 17, 2018
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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