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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 16, 2018
First Posted Date  ICMJE October 18, 2018
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • Lymphedema Quality of Life questionnaire [ Time Frame: 6 weeks ]
  • Pain indicated on a visual analog scale [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
Official Title  ICMJE Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
prospective observational study with a diet intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lipedema
  • Obesity, Morbid
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Low carbohydrate high fat diet
Low carbohydrate high fat (LCHF) diet
Intervention: Dietary Supplement: Low carbohydrate high fat diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2018)
20
Actual Study Completion Date  ICMJE January 10, 2019
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03710798
Other Study ID Numbers  ICMJE 2018/307
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Central Norway Regional Health Authority
Study Sponsor  ICMJE Central Norway Regional Health Authority
Collaborators  ICMJE
  • St. Olavs Hospital
  • University of Oslo
Investigators  ICMJE
Study Director: Bodil Landstad, prof Norwegian University for Science and Technology
PRS Account Central Norway Regional Health Authority
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP