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

NCT ID: NCT03710798

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-01-10

Brief Summary

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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

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Conditions

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Lipedema Obesity, Morbid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective observational study with a diet intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low carbohydrate high fat diet

Low carbohydrate high fat (LCHF) diet

Group Type EXPERIMENTAL

Low carbohydrate high fat diet

Intervention Type DIETARY_SUPPLEMENT

Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet

Interventions

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Low carbohydrate high fat diet

Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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ketogenic diet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bodil Landstad, prof

Role: STUDY_DIRECTOR

Norwegian University for Science and Technology

Locations

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Obesity Clinic, St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2018/307

Identifier Type: -

Identifier Source: org_study_id

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