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Cholesterol, LDLMYDICLINNCT03528252

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

A study testing Written advice LDL Cholesterol and Written advice Triglycerides in people with Cholesterol, LDL, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Cholesterol, LDL
What is being tested?
Written advice LDL Cholesterol and Written advice Triglycerides
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
1 siteSweden
Study dates
16 May 2018to 18 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Listed patient at Svärdsjö Primary Health Care Centre
  • Willing to reduce blood lipids

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Svärdsjö Primary Health Care Centre

    Falun, Dalarna County, 79023

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Written advice LDL Cholesterol, Written advice Triglycerides
Keywords
cholesterol, LDL cholesterol, Triglycerides, Diet, Food, Lipoproteins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Written advice LDL CholesterolOther

    Also called Active Intervention

    One A4 paper with written information on both sides

  • Written advice TriglyceridesOther

    Also called Control Group

    One A4 paper with written information on both sides

Study groups in NCT03528252
Study groupRoleWhat they receive
LDL CholesterolActive comparatorWill receive dietary advice effective for reducing LDL cholesterol.
Receives: Other: Written advice LDL Cholesterol
TriglyceridesSham comparatorWill not be aware that they are in fact Control Group. Will receive dietary advice effective for reducing Triglycerides, but neutral for LDL cholesterol.
Receives: Other: Written advice Triglycerides

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LDL Cholesterol

    Change in plasma LDL Cholesterol levels

    Measured: 3 weeks and 6 months

Secondary outcomes (11)

  1. Total Cholesterol

    Change in plasma Total Cholesterol levels

    Measured: 3 weeks and 6 months

  2. HDL Cholesterol

    Change in plasma HDL Cholesterol levels

    Measured: 3 weeks and 6 months

  3. Apolipoproteins

    Change in plasma Apolipoprotein levels

    Measured: 3 weeks and 6 months

  4. Success rate

    Percentage of participants that reduce LDL Cholesterol at least 10%

    Measured: 3 weeks and 6 months

  5. Responder effect

    Change in plasma LDL cholesterol after 6 months in participants that reduce LDL Cholesterol at least 10% at 3 weeks

    Measured: 6 months and 3 weeks, respectively

  6. Double sampling requirement

    Number of participants that would have been misclassified if not double sampling hade been performed for LDL cholesterol

    Measured: 3 weeks and 6 months

  7. Cost of intervention

    Cost of intervention, in comparison to possible health gains

    Measured: 3 weeks and 6 months

  8. Effective food choices

    Food choices that are in practice effective for lowering LDL cholesterol

    Measured: 3 weeks and 6 months

  9. Stated reasons

    Stated reasons for wanting to improve blood lipid profile and associations with effect on LDL Cholesterol

    Measured: 3 weeks and 6 months

  10. PSCK9

    Change in serum PCSK9 levels

    Measured: 3 weeks and 6 months

  11. Lipoprotein(a)

    Change in plasma lipoprotein(a) levels

    Measured: 3 weeks and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2018
  2. Study start16 May 2018
  3. Primary completion18 Apr 2019
  4. Study completion18 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two identical parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03528252
Sponsor's protocol ID
MYDICLIN
Other IDs
Dnr 2018/119
Acronym
MYDICLIN
Status last verified
Apr 2019
First submitted
19 Apr 2018
Last updated
26 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: N/A, data sharing is not included in Ethics application. Further consent from participants may be required.

Questions about this trial

What is this clinical trial studying?

A study testing Written advice LDL Cholesterol and Written advice Triglycerides in people with Cholesterol, LDL, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LDL Cholesterol (time frame: 3 weeks and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03528252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.

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