Effect of an Low Carbon High Fat Diet on Pain- and Qualit... | NCT03710798

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

NCT03710798

Sponsor

Helse Nord-Trøndelag HF

Status

Completed

Last Update Posted

Feb 26, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Lipedema
Obesity, Morbid

Interventions

Low carbohydrate high fat diet

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Jan 10, 2019Actual

Completion Date

Jan 10, 2019Actual

First Submitted Date

Oct 16, 2018

First Submission Date that Met QC Criteria

Oct 16, 2018

First Posted Date

Oct 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2019

Last Update Posted Date

Feb 26, 2019Actual

Name	Class
St. Olavs Hospital	OTHER
University of Oslo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low carbohydrate high fat diet	Experimental	Low carbohydrate high fat (LCHF) diet	Dietary Supplement: Low carbohydrate high fat diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low carbohydrate high fat diet	Dietary Supplement	Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet	Low carbohydrate high fat diet

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bodil Landstad, prof	Norwegian University for Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Obesity Clinic, St Olavs Hospital		Trondheim			Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065134	Lipedema
D009767	Obesity, Morbid
D010146	Pain

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D009765	Obesity
D050177	Overweight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055423	Diet, Ketogenic

Ancestor Terms

ID	Term
D050528	Diet, Carbohydrate-Restricted
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided