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

U

Uppsala University

Status

Completed

Conditions

Cholesterol, LDL

Treatments

Other: Written advice Triglycerides
Other: Written advice LDL Cholesterol

Study type

Interventional

Funder types

Other

Identifiers

NCT03528252
Dnr 2018/119 (Other Identifier)
MYDICLIN

Details and patient eligibility

About

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.

Full 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.

Enrollment

113 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

113 participants in 2 patient groups

LDL Cholesterol
Active Comparator group
Description:
Will receive dietary advice effective for reducing LDL cholesterol.
Treatment:
Other: Written advice LDL Cholesterol
Triglycerides
Sham Comparator group
Description:
Will not be aware that they are in fact Control Group. Will receive dietary advice effective for reducing Triglycerides, but neutral for LDL cholesterol.
Treatment:
Other: Written advice Triglycerides

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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