LipedemaLipodietNCT04632810
Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
A study testing Ketogenic low energy diet and non-ketogenic low energy diet in people with Lipedema, run by Helse Nord-Trøndelag HF at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Ketogenic low energy diet and non-ketogenic low energy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesNorway
- Study dates
- 22 Mar 2021to 11 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Levanger Hospital, Nord-Trøndelag Hospital Trust
Levanger
St Olavs Hospital
Trondheim
About this study
Official title: The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
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.
Read the 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).
- Conditions
- Lipedema
- Being tested
- Ketogenic low energy diet, non-ketogenic low energy diet
- Keywords
- Diet therapy, Ketosis, Pain, Weight loss
- Medical subject headings
- Lipedema, Ketosis, Pain, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic low energy dietOther
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
non-ketogenic low energy dietOther
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
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic low energy diet | Experimental | Ketogenic low energy diet for 8 weeks Receives: Other: Ketogenic low energy diet |
| non-Ketogenic low energy diet | Active comparator | non-Ketogenic low energy diet for 8 weeks Receives: Other: non-ketogenic low energy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
change in quality of life
Likert Scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start22 Mar 2021
- Primary completion1 Jul 2023
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, St. Olavs Hospital, Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Siren Nymo, PhD, Principal investigator, Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of SurgeryHallvard Græslie, md, Study director, Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632810
- Sponsor's protocol ID
- 93888
- Acronym
- Lipodiet
- Status last verified
- Jul 2026
- First submitted
- 12 Nov 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40125475Lundanes 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.
PubMed 39566600Lundanes 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.
PubMed 39574523Lundanes J, Sandnes F, Gjeilo KH, Hansson P, Salater S, Martins C, Nymo S. Effect of a low-carbohydrate diet on pain and quality of life in female patients with lipedema: a randomized controlled trial. Obesity (Silver Spring). 2024 Jun;32(6):1071-1082. doi: 10.1002/oby.24026. Epub 2024 Apr 16.
PubMed 38627016
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
- ClinicalTrials.gov ID
- NCT04632810
- Acronym / sponsor ID
- Lipodiet / 93888
- Conditions
- Lipedema
- Keywords
- Diet therapy, Ketosis, Pain, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, St. Olavs Hospital, Vanderbilt University Medical Center
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic low energy diet | Experimental | Other: Ketogenic low energy dietKetogenic low energy diet for 8 weeks |
| non-Ketogenic low energy diet | Active comparator | Other: non-ketogenic low energy dietnon-Ketogenic low energy diet for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Pregnant or breast feeding
- History of infectious diseases
- Medication known to affect obesity
- Enrolled in any other obesity treatment
- Having had bariatric surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic low energy dietParticipants 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 | Other | Ketogenic low energy diet |
| non-ketogenic low energy dietParticipants 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 | Other | non-Ketogenic low energy diet |
Primary outcome
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
change in quality of life
Time frame: 8 weeks
Likert Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Results publication: PubMed 40125475Lundanes 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.
- Results publication: PubMed 39566600Lundanes 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.
- Results publication: PubMed 39574523Lundanes 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.
- Results publication: PubMed 38627016Lundanes J, Sandnes F, Gjeilo KH, Hansson P, Salater S, Martins C, Nymo S. Effect of a low-carbohydrate diet on pain and quality of life in female patients with lipedema: a randomized controlled trial. Obesity (Silver Spring). 2024 Jun;32(6):1071-1082. doi: 10.1002/oby.24026. Epub 2024 Apr 16.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siren Nymo, PhD principal investigator
Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
Hallvard Græslie, md study director
Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic low energy diet and non-ketogenic low energy diet in people with Lipedema, run by Helse Nord-Trøndelag HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain intensity (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632810, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.