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

February 25, 2019 updated by: Helse Nord-Trøndelag HF
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Obesity Clinic, St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • ketogenic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lymphedema Quality of Life questionnaire
Time Frame: 6 weeks
6 weeks
Pain indicated on a visual analog scale
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Nord-Trøndelag HF

Collaborators

University of Oslo
St. Olavs Hospital

Investigators

  • Study Director: Bodil Landstad, prof, Norwegian University for Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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