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

Primary Purpose

Lipedema, Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Low carbohydrate high fat diet
Sponsored by
Helse Nord-Trøndelag HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipedema focused on measuring Diet, ketogenic, Pain, Quality of Life, Body Composition, Body Fat Distribution

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Obesity Clinic, St Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low carbohydrate high fat diet

Arm Description

Low carbohydrate high fat (LCHF) diet

Outcomes

Primary Outcome Measures

Lymphedema Quality of Life questionnaire
Pain indicated on a visual analog scale

Secondary Outcome Measures

Full Information

First Posted
October 16, 2018
Last Updated
February 25, 2019
Sponsor
Helse Nord-Trøndelag HF
Collaborators
St. Olavs Hospital, University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT03710798
Brief Title
Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
Acronym
LIPODIET
Official Title
Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
St. Olavs Hospital, University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipedema, Obesity, Morbid
Keywords
Diet, ketogenic, Pain, Quality of Life, Body Composition, Body Fat Distribution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective observational study with a diet intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low carbohydrate high fat diet
Arm Type
Experimental
Arm Description
Low carbohydrate high fat (LCHF) diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Low carbohydrate high fat diet
Other Intervention Name(s)
ketogenic diet
Intervention Description
Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet
Primary Outcome Measure Information:
Title
Lymphedema Quality of Life questionnaire
Time Frame
6 weeks
Title
Pain indicated on a visual analog scale
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil Landstad, prof
Organizational Affiliation
Norwegian University for Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Obesity Clinic, St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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