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

  • STATUS
    Recruiting
  • End date
    Apr 9, 2023
  • participants needed
    81
  • sponsor
    Helse Nord-Trøndelag HF
Updated on 9 April 2022

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 three diets. 1) enery balanced (weight maintenance) ketogenic diet, 2) energy-restricted ketogenic diet and 3) energy-restricted low-fat non-ketogenic diet with a view of 10% weight loss within 10 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.

Details
Condition Lipedema
Treatment Ketogenic diet until reaching 10% weight loss, non-ketogenic diet until reaching 10% weight loss, Ketogenic eucaloric diet for weight stability
Clinical Study IdentifierNCT04632810
SponsorHelse Nord-Trøndelag HF
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed with lipedema by skilled physical therapists
Body mass index > 30kg/m2 and < 45kg/m2
Stable weight over the last three months (+2-3kg)
Not currently dieting to lose weight
Willing to meet for follow-ups every second week during the intervention
Willing to sign an informed consent before entering the study

Exclusion Criteria

Pregnant or breast feeding
History of infectious diseases
Medication known to affect obesity
Enrolled in any other obesity treatment
Having had bariatric surgery
Kidney disease is excluded
History of psychological disorders
Not mastering a Scandinavian language
Being mentally disabled
Malign disease
Diabetes
Any disease that leads to dietary advice that is not consistent with intervention advice
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