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

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ClinicalTrials.gov Identifier: NCT04632810
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : March 23, 2022
Sponsor:
Collaborators:
Norwegian University of Science and Technology
St. Olavs Hospital
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Helse Nord-Trøndelag HF

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Lipedema Other: Ketogenic diet until reaching 10% weight loss Other: non-ketogenic diet until reaching 10% weight loss Other: Ketogenic eucaloric diet for weight stability Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketogenic diet + weight loss Other: Ketogenic diet until reaching 10% weight loss
Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 50g (17E%), protein 60 g (20E%), fat 84 g (63E%), until reaching 10% weight loss (approximately 10weeks).
Active Comparator: non-Ketogenic diet + weight loss Other: non-ketogenic diet until reaching 10% weight loss
Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 150g (50E%), protein 60 g (20E%), fat 40 g (30E%), until reaching 10% weight loss (approximately 10weeks).
Active Comparator: Ketogenic eucaloric diet Other: Ketogenic eucaloric diet for weight stability
Participants will follow a low-calory-high-fat diet for 10 weeks. Carbohydrates10E%, protein 20E% and fat:70E%. Dietary plans will be based on individual measurement of energy needs by resting metabolic rate and physical activity level.


Outcome Measures
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Primary Outcome Measures :
  1. change in pain intensity [ Time Frame: 11 weeks ]
    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

  2. change in quality of life [ Time Frame: 11 weeks ]
    Likert Scale 1 best to 4 worst


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632810


Contacts
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Contact: Siren Nymo, phd +47 99514188 siren.nymo@ntnu.no
Contact: Heidi Annet Holm

Locations
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Norway
Levanger Hospital, Nord-Trøndelag Hospital Trust Recruiting
Levanger, Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Siren Nymo, phd       siren.nymo@ntnu.no   
Sponsors and Collaborators
Helse Nord-Trøndelag HF
Norwegian University of Science and Technology
St. Olavs Hospital
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Siren Nymo, phd Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
Study Director: Hallvard Græslie, md Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
More Information
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Responsible Party: Helse Nord-Trøndelag HF
ClinicalTrials.gov Identifier: NCT04632810    
Other Study ID Numbers: 93888
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: March 23, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helse Nord-Trøndelag HF:
Diet therapy
Ketosis
Pain
Weight loss
Additional relevant MeSH terms:
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Lipedema
Ketosis
Acidosis
 Acid-Base Imbalance
Metabolic Diseases
Connective Tissue Diseases