Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema

Summary

Lipedema is a female progressive fat disorder, characterized by a symmetrical increase in subcutaneous adipose tissue in the lower extremities with the exception of the waist. The condition is often misdiagnosed and underdiagnosed. The etiology is poorly understood. Affects about 11% of all women and may lead to pain and immobility. The pathophysiology may be related to sex hormones and inflammatory response. Lipedema fat has been reported not to respond to lifestyle changes or bariatric surgery, both in terms of weight loss and symptom reduction; including pain and quality of life. Clinical research on the effect of dietary interventions on lipedema does not exist, but a pilot study with a ketogenic diet showed a significant reduction in pain regardless of weight loss. The aim of the research project will be to investigate whether a ketogenic diet can be a treatment option for patients with lipedema. Therefore, a randomized controlled trial will be conducted to compare the effects of two diets. 1) energy-restricted ketogenic diet and 3) energy-restricted low-fat non-ketogenic diet for 8 weeks. Pain and quality of life will be mesured at start and immediately after the intervention. The hypothesis is that a ketogenic diet may reduce pain and improve quality of life.

Conditions

• Lipedema

Interventions

OTHER

Ketogenic low energy diet

Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 75g (25E%), protein 60 g (20E%), fat 73 g (55E%) in 8 weeks

OTHER

non-ketogenic low energy diet

Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 180g (60E%), protein 60 g (20E%), fat 27 g (20E%), in 8 weeks

Sponsors & Collaborators

• Norwegian University of Science and Technology

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• Helse Nord-Trøndelag HF

  lead OTHER

Principal Investigators

• Siren Nymo, PhD · Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery

• Hallvard Græslie, md · Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-22

Primary Completion

2023-07-01

Completion

2025-04-30

Countries

• Norway

Study Locations