LipedemaLIPODIETNCT03710798
Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
A study testing Low carbohydrate high fat diet in people with Lipedema and Obesity, Morbid, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial summary
Lipedema is a chronic disease with unproportional, symmetrical fat accumulation in the lower extremities. Patients experience pain in affected areas, and reduced quality of life. Today's treatment is physiotherapy and surgery (liposuction). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lipedema, Obesity, Morbid
- What is being tested?
- Low carbohydrate high fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2018to 10 Jan 2019
- 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
- weight stable over the last three months (+ 2-3 kg)
- not currently dieting to loose weight.
- willing to meet for weekly follow-ups during the intervention and the reintroduction of a regular diet.
- sign an informed consent before entering the study.
Who cannot join
- pregnant or breast feeding
- history of infectious diseases
- medication known to affect obesity
- enrolment in any other obesity treatment
- have had a bariatric surgery
- history of psychological disorders
Show all 9Show fewer
- mentally disabled
- not mastering a Scandinavian language
- having a malign disease or any disease that leads to dietary advice that is not consistent with intervention advices in the study
Trial locations and contacts
1 site in 1 country.
About this study
Lipedema is a chronic disease with unproportional, symmetrical fat accumulation in the lower extremities. Patients experience pain in affected areas, and reduced quality of life. Today's treatment is physiotherapy and surgery (liposuction). Recent research shows that ketogenic-diet with low carbohydrate, high fat (LCHF) conant can lead to reduced pain, increased quality of life and change in body composition. Goals: Investigate the effect of LCHF diet on pain, quality of life and body composition.
- Conditions
- Lipedema, Obesity, Morbid
- Being tested
- Low carbohydrate high fat diet
- Keywords
- Diet, ketogenic, Pain, Quality of Life, Body Composition, Body Fat Distribution
- Medical subject headings
- Lipedema, Obesity, Morbid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate high fat dietDietary supplement
Also called ketogenic diet
Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate high fat diet | Experimental | Low carbohydrate high fat (LCHF) diet Receives: Dietary Supplement: Low carbohydrate high fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphedema Quality of Life questionnaire
Measured: 6 weeks
Pain indicated on a visual analog scale
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Oct 2018
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- prospective observational study with a diet intervention
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Bodil Landstad, prof, Study director, Norwegian University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710798
- Sponsor's protocol ID
- 2018/307
- Acronym
- LIPODIET
- Status last verified
- Feb 2019
- First submitted
- 16 Oct 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema
- ClinicalTrials.gov ID
- NCT03710798
- Acronym / sponsor ID
- LIPODIET / 2018/307
- Conditions
- Lipedema, Obesity, Morbid
- Keywords
- Diet, ketogenic, Pain, Quality of Life, Body Composition, Body Fat Distribution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University of Oslo
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 18 Oct 2018 (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 chronic disease with unproportional, symmetrical fat accumulation in the lower extremities. Patients experience pain in affected areas, and reduced quality of life. Today's treatment is physiotherapy and surgery (liposuction). Recent research shows that ketogenic-diet with low carbohydrate, high fat (LCHF) conant can lead to reduced pain, increased quality of life and change in body composition. Goals: Investigate the effect of LCHF diet on pain, quality of life and body composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective observational study with a diet intervention
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate high fat diet | Experimental | Dietary Supplement: Low carbohydrate high fat dietLow carbohydrate high fat (LCHF) diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- weight stable over the last three months (+ 2-3 kg)
- not currently dieting to loose weight.
- willing to meet for weekly follow-ups during the intervention and the reintroduction of a regular diet.
- sign an informed consent before entering the study.
Key exclusion criteria (9 listed)
- pregnant or breast feeding
- history of infectious diseases
- medication known to affect obesity
- enrolment in any other obesity treatment
- have had a 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 |
|---|---|---|
| Low carbohydrate high fat dietAlso: ketogenic dietEnergy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet | Dietary supplement | Low carbohydrate high fat diet |
Primary outcome
Lymphedema Quality of Life questionnaire
Time frame: 6 weeks
Pain indicated on a visual analog scale
Time frame: 6 weeks
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 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Bodil Landstad, prof study director
Norwegian University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate high fat diet in people with Lipedema and Obesity, Morbid, run by Helse Nord-Trøndelag HF at 1 site 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 4 inclusion and 9 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Lymphedema Quality of Life questionnaire (time frame: 6 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?
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 26 Feb 2019.