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

Obesity, Morbid Clinical Trial

— LIPODIET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710798
• Other study ID #: 2018/307
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: February 2019
• Source: Central Norway Regional Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lipedema
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Norway	Obesity Clinic, St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Central Norway Regional Health Authority	St. Olavs Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphedema Quality of Life questionnaire		6 weeks
Primary	Pain indicated on a visual analog scale		6 weeks