Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema (Lipodiet)
Primary Purpose
Lipedema
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ketogenic diet until reaching 10% weight loss
non-ketogenic diet until reaching 10% weight loss
Ketogenic eucaloric diet for weight stability
Sponsored by
About this trial
This is an interventional treatment trial for Lipedema focused on measuring Diet therapy, Ketosis, Pain, Weight loss
Eligibility 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
Sites / Locations
- Levanger Hospital, Nord-Trøndelag Hospital TrustRecruiting
- St Olavs HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Ketogenic diet + weight loss
non-Ketogenic diet + weight loss
Ketogenic eucaloric diet
Arm Description
Outcomes
Primary Outcome Measures
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
change in quality of life
Likert Scale 1 best to 4 worst
Secondary Outcome Measures
Full Information
NCT ID
NCT04632810
First Posted
November 12, 2020
Last Updated
April 12, 2023
Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology, St. Olavs Hospital, Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04632810
Brief Title
Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
Acronym
Lipodiet
Official Title
The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology, St. Olavs Hospital, Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipedema
Keywords
Diet therapy, Ketosis, Pain, Weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet + weight loss
Arm Type
Experimental
Arm Title
non-Ketogenic diet + weight loss
Arm Type
Active Comparator
Arm Title
Ketogenic eucaloric diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Ketogenic diet until reaching 10% weight loss
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
non-ketogenic diet until reaching 10% weight loss
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Ketogenic eucaloric diet for weight stability
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in pain intensity
Description
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
Time Frame
11 weeks
Title
change in quality of life
Description
Likert Scale 1 best to 4 worst
Time Frame
11 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siren Nymo, phd
Phone
+47 99514188
Email
siren.nymo@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Annet Holm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siren Nymo, phd
Organizational Affiliation
Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hallvard Græslie, md
Organizational Affiliation
Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Levanger Hospital, Nord-Trøndelag Hospital Trust
City
Levanger
Country
Norway
Individual Site Status
Recruiting
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siren Nymo, phd
Email
siren.nymo@ntnu.no
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
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