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

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ClinicalTrials.gov Identifier: NCT03710798
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
University of Oslo
Information provided by (Responsible Party):
Central Norway Regional Health Authority

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lipedema Obesity, Morbid Dietary Supplement: Low carbohydrate high fat diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective observational study with a diet intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Arm Intervention/treatment
Experimental: Low carbohydrate high fat diet
Low carbohydrate high fat (LCHF) diet
Dietary Supplement: Low carbohydrate high fat diet
Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet
Other Name: ketogenic diet




Primary Outcome Measures :
  1. Lymphedema Quality of Life questionnaire [ Time Frame: 6 weeks ]
  2. Pain indicated on a visual analog scale [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03710798


Locations
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Norway
Obesity Clinic, St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Central Norway Regional Health Authority
St. Olavs Hospital
University of Oslo
Investigators
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Study Director: Bodil Landstad, prof Norwegian University for Science and Technology

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Responsible Party: Central Norway Regional Health Authority
ClinicalTrials.gov Identifier: NCT03710798     History of Changes
Other Study ID Numbers: 2018/307
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Central Norway Regional Health Authority:
Diet, ketogenic
Pain
Quality of Life
Body Composition
Body Fat Distribution

Additional relevant MeSH terms:
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Obesity, Morbid
Lipedema
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Connective Tissue Diseases