- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04632810
Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema (Lipodiet)
The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design RCT comparing a low-energy ketogenic diet to a non-ketogenic low-energy diet (non-keto) in females with lipedema. This study was approved by the Reginal Ethical Committee (REK 93888) All participants have to provided written informed consent in line with the Helsinki Declaration, before entering the study. Participants will be randomized by block randomization with stratification by BMI categories.
Study population Females diagnosed with lipedema, aged 18-75 years old, and a BMI between 30-45 kg/m2, will be invited to participate in this study. Participants had to be diagnosed with lipedema by physiotherapists before inclusion. Inclusion criteria includs weight stability for the last three months (±3 kg).
Dietary interventions Diets were matched for energy (1200 kcal/day) and protein, but differed in carbohydrate (CHO) and fat content.
The dietary plans are adjusted with respect to food preferences, intolerances, and allergies. The participants will be asked not to change their physical activity levels throughout the study period.
Compliance Participants will have weekly follow-ups. Participants will be asked to fill out daily food records throughout the intervention period.
Ketostix will be used in the weekly follow-ups to measure urinary acetoacetate (AcAc). If the participants in the keto group were outside of ketosis, or participants in the non-keto group in ketosis, >2 times throughout the study period, they were excluded from the per-protocol (PP) analysis.
Outcome variables
The following variables were assessed at baseline and at the end of the intervention:
Anthropometrics and body composition Height and weight will be measured at baseline. Body composition will be assessed in fasting state with Bioelectrical Impedance Analysis before and after the intervention..
Pain Pain will be assessed with the brief Pain Inventory. The participants rated their pain in a numerical rating scale (NRS), where 0 = no pain and 10 = Worst imaginable pain. The BPI assesses pain intensity: strongest pain, weakest pain, average pain, pain now, pain severity score using an average of pain intensity domains, and pain inference from daily activities, mood, walking, regular work, relationships, sleep and life joy. A pain inference score is also computed as the average of all pain inference domains.
Three different questionnaires are used to assess Quality of life. RAND-36. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) q and the Lymphoedema Quality of Life (LYMQOL).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Siren Nymo, phd
- Phone Number: +47 99514188
- Email: siren.nymo@ntnu.no
Study Contact Backup
- Name: Heidi Annet Holm
Study Locations
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Levanger, Norway
- Levanger Hospital, Nord-Trøndelag Hospital Trust
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Trondheim, Norway
- St Olavs Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketogenic low energy diet
Ketogenic low energy diet for 8 weeks
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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
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Active Comparator: non-Ketogenic low energy diet
non-Ketogenic low energy diet for 8 weeks
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in pain intensity
Time Frame: 8 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
|
8 weeks
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change in quality of life
Time Frame: 8 weeks
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Likert Scale
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8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 93888
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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