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ACTIVE NOT RECRUITING
NCT04632810
NA

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

Sponsor: Helse Nord-Trøndelag HF

View on ClinicalTrials.gov

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.

Official title: The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2021-03-22

Completion Date

2025-04

Last Updated

2025-03-13

Healthy Volunteers

No

Conditions

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

Locations (2)

Levanger Hospital, Nord-Trøndelag Hospital Trust

Levanger, Norway

St Olavs Hospital

Trondheim, Norway