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OpenTrials
Completed

NCT Number: NCT03710798

Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema

Lipedema is a chronic disease with unproportional, symmetrical fat accumulation in the lower extremities. Patients experience pain in affected areas, and reduced quality of life. Today's treatment is physiotherapy and surgery (liposuction). Recent research shows that ketogenic-diet with low carbohydrate, high fat (LCHF) conant can lead to reduced pain, increased quality of life and change in body composition. Goals: Investigate the effect of LCHF diet on pain, quality of life and body composition.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obesity Clinic, St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • weight stable over the last three months (+ 2-3 kg)
  • not currently dieting to loose weight.
  • willing to meet for weekly follow-ups during the intervention and the reintroduction of a regular diet.
  • sign an informed consent before entering the study.

Exclusion criteria

  • pregnant or breast feeding
  • history of infectious diseases
  • medication known to affect obesity
  • enrolment in any other obesity treatment
  • have had a bariatric surgery
  • history of psychological disorders
  • mentally disabled
  • not mastering a Scandinavian language
  • having a malign disease or any disease that leads to dietary advice that is not consistent with intervention advices in the study

Treatment and study plan

Low carbohydrate high fat diet

Dietary Supplement

Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet

Other names: ketogenic diet

Primary outcomes

  1. Lymphedema Quality of Life questionnaire

    Time frame: 6 weeks

  2. Pain indicated on a visual analog scale

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Collaborators

  • St. Olavs Hospital
  • University of Oslo

Registry information

Acronym: LIPODIET

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2018
Registry last updated
Feb 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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