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

NCT04632810 | Active Not Recruiting

• 1 other identifier: 93888
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Diet therapy; Ketosis; Pain; Weight loss

Outcome Measures

Primary Outcomes (2)

• change in pain intensity

  A difference in mean pain score of 2 units on a continuous scale from 0 to 10 on a visual analog scale (VAS) is considered clinically interesting

  8 weeks

• change in quality of life

  Likert Scale

  8 weeks

Study Arms (2)

Ketogenic low energy diet

EXPERIMENTAL

Ketogenic low energy diet for 8 weeks

Other: Ketogenic low energy diet

non-Ketogenic low energy diet

ACTIVE COMPARATOR

non-Ketogenic low energy diet for 8 weeks

Other: non-ketogenic low energy diet

Interventions

Ketogenic low energy diet OTHER

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

Ketogenic low energy diet

non-ketogenic low energy diet OTHER

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

non-Ketogenic low energy 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• Norwegian University of Science and Technology: collaborator
• St. Olavs Hospital: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (2)

Levanger Hospital, Nord-Trøndelag Hospital Trust

Levanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (3)

• Lundanes J, Nes VF, Aakervik O, Ryan L, Hansson P, Rokstad AM, Martins C, Nymo S. Changes in Cytokines and Fibrotic Growth Factors after Low-Carbohydrate or Low-Fat Low-Energy Diets in Females with Lipedema. Curr Dev Nutr. 2025 Feb 20;9(3):104571. doi: 10.1016/j.cdnut.2025.104571. eCollection 2025 Mar.

  PMID: 40125475 DERIVED

• Lundanes J, Garseth M, Taylor S, Crescenzi R, Pridmore M, Wagnild R, Hyldmo AA, Martins C, Nymo S. The effect of a low-carbohydrate diet on subcutaneous adipose tissue in females with lipedema. Front Nutr. 2024 Nov 7;11:1484612. doi: 10.3389/fnut.2024.1484612. eCollection 2024.

  PMID: 39574523 DERIVED

• Lundanes J, Storlilokken GE, Solem MS, Dankel SN, Tangvik RJ, Odegard R, Holst JJ, Rehfeld JF, Martins C, Nymo S. Gastrointestinal hormones and subjective ratings of appetite after low-carbohydrate vs low-fat low-energy diets in females with lipedema - A randomized controlled trial. Clin Nutr ESPEN. 2025 Feb;65:16-24. doi: 10.1016/j.clnesp.2024.11.018. Epub 2024 Nov 19.

  PMID: 39566600 DERIVED

MeSH Terms

Conditions

Lipedema; Ketosis; Pain; Weight Loss

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight

Study Officials

• Siren Nymo, PhD

  Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery

  PRINCIPAL INVESTIGATOR

• Hallvard Græslie, md

  Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 17, 2020
• Study Start: March 22, 2021
• Primary Completion: July 1, 2023
• Study Completion: April 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)