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

NCT03710798 | Completed

• 1 other identifier: 2018/307
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema; Obesity, Morbid

Keywords

Diet, ketogenic; Pain; Quality of Life; Body Composition; Body Fat Distribution

Outcome Measures

Primary Outcomes (2)

• Lymphedema Quality of Life questionnaire

  6 weeks

• Pain indicated on a visual analog scale

  6 weeks

Study Arms (1)

Low carbohydrate high fat diet

EXPERIMENTAL

Low carbohydrate high fat (LCHF) diet

Dietary Supplement: Low carbohydrate high fat diet

Interventions

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

Also known as: ketogenic diet

Low carbohydrate high fat diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• St. Olavs Hospital: collaborator
• University of Oslo: collaborator

Study Sites (1)

Obesity Clinic, St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Lipedema; Obesity, Morbid; Pain

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bodil Landstad, prof

  Norwegian University for Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective observational study with a diet intervention

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: October 1, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

NO (1)