LipedemaNCT07853833
The Effect of Mediterranean Diet on Pain Level and Biochemical Parameters in Women With Lipedema
A study testing Mediterranean Diet-Based Nutritional Intervention in people with Lipedema, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To evaluate the effects of a 3-month Mediterranean diet-based intervention on anthropometric and metabolic outcomes, pain and central sensitisation-related symptoms in women with lipedema. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Mediterranean Diet-Based Nutritional Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 26 Apr 2026
- 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 19 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women were eligible for inclusion if they had a clinical diagnosis of lipedema, were aged 19-64 years, and voluntarily agreed to participate in the study.
Who cannot join
- Participants were excluded if they had a diagnosis of lymphedema, had previously undergone bariatric surgery, were pregnant or breastfeeding, or had experienced a ≥5% change in body weight during the preceding 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate the effects of a 3-month Mediterranean diet-based intervention on anthropometric and metabolic outcomes, pain and central sensitisation-related symptoms in women with lipedema.
Methods: In this non-randomised controlled intervention study, 86 women with lipedema were enrolled and 67 completed the study (intervention, n 33; control, n 34). Participants were allocated alternately according to enrolment order. The intervention group received an individualised energy-restricted Mediterranean diet (1300-1500 kcal/d) for 3 months, whereas controls received no dietary intervention. MEDAS, CSI and VAS scores, anthropometric measurements, and biochemical and inflammatory parameters were assessed.
Read more
Results: After 3 months, the intervention group showed improvements in anthropometric measures and lipid profile, whereas changes in inflammatory markers were limited. MEDAS scores increased from 4.8 to 10.7, CSI scores decreased from 40.2 to 16.3 and VAS scores decreased from 4.1 to 0.9; corresponding changes in controls were 4.1 to 2.7, 41.2 to 43.4 and 3.7 to 5.0, respectively (all between-group changes, p < 0.001). In the intervention group, higher MEDAS scores remained significantly associated with lower pain after accounting for body-weight change (β = -0.471, p= 0.005), whereas body-weight change was not significantly associated with final VAS score (β = 0.201, p= 0.208).
Conclusions: A 3-month Mediterranean diet-based intervention was associated with improvements in pain, central sensitisation-related symptoms and anthropometric and metabolic outcomes in women with lipedema. Larger randomised controlled trials with longer follow-up are warranted.
- Conditions
- Lipedema
- Being tested
- Mediterranean Diet-Based Nutritional Intervention
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet-Based Nutritional InterventionBehavioural
Participants in the intervention group received an individualised, energy-restricted Mediterranean diet-based nutritional intervention for 3 months. Individual energy requirements were estimated using the Harris-Benedict equation, and dietary plans providing 1300-1500 kcal/day were prescribed. The diets provided approximately 35-40% of total energy from carbohydrates, 20-25% from protein and 35-40% from fat. The intervention emphasised vegetables, fruits, whole grains, legumes, nuts and olive oil as the principal source of added fat; encouraged regular consumption of fish and poultry; and limited red and processed meats, refined carbohydrates and added sugars. Participants attended monthly outpatient visits and received individual dietary plans electronically on a weekly basis. Adherence to the dietary intervention was reinforced and monitored through weekly telephone contacts.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Intervention | Experimental | Not described Receives: Behavioral: Mediterranean Diet-Based Nutritional Intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Assessed by the Visual Analogue Scale
Pain intensity was assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Total and regional pain scores were assessed.
Measured: Baseline, 1 month, 2 months, and 3 months
Secondary outcomes (1)
Change in Central Sensitisation-Related Symptoms Assessed by the Central Sensitization Inventory
Central sensitisation-related symptoms were assessed using Part A of the Central Sensitization Inventory (CSI). The CSI consists of 25 items scored from 0 to 4, yielding a total score ranging from 0 to 100. Higher scores indicate a greater burden of central sensitisation-related symptoms.
Measured: Baseline, 1 month, 2 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 May 2025
- Primary completion29 Jan 2026
- Study completion26 Apr 2026
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An a priori sample size calculation was performed using G\*Power. Based on the comparison of mean scale scores between two groups, assuming a medium effect size (d = 0.50), 90 % statistical power and a two-sided significance level of 5 %, a minimum total sample size of 46 participants (23 participants per group) was required. A total of 86 participants were enrolled in the study. Eligible participants were allocated sequentially to the intervention and control groups according to their order of presentation to the outpatient clinic. No randomisation procedure was used; participants were assigned alternately to the intervention and control groups as they were enrolled. During the follow-up period, nineteen participants did not complete the study.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853833
- Sponsor's protocol ID
- KA25/82
- Status last verified
- May 2025
- First submitted
- 23 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mediterranean Diet on Pain Level and Biochemical Parameters in Women With Lipedema
- ClinicalTrials.gov ID
- NCT07853833
- Acronym / sponsor ID
- KA25/82
- Conditions
- Lipedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 26 Apr 2026 (actual)
- First posted
- 2 Oct 2026 (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.
Objective: To evaluate the effects of a 3-month Mediterranean diet-based intervention on anthropometric and metabolic outcomes, pain and central sensitisation-related symptoms in women with lipedema.
Methods: In this non-randomised controlled intervention study, 86 women with lipedema were enrolled and 67 completed the study (intervention, n 33; control, n 34). Participants were allocated alternately according to enrolment order. The intervention group received an individualised energy-restricted Mediterranean diet (1300-1500 kcal/d) for 3 months, whereas controls received no dietary intervention. MEDAS, CSI and VAS scores, anthropometric measurements, and biochemical and inflammatory parameters were assessed.
Results: After 3 months, the intervention group showed improvements in anthropometric measures and lipid profile, whereas changes in inflammatory markers were limited. MEDAS scores increased from 4.8 to 10.7, CSI scores decreased from 40.2 to 16.3 and VAS scores decreased from 4.1 to 0.9; corresponding changes in controls were 4.1 to 2.7, 41.2 to 43.4 and 3.7 to 5.0, respectively (all between-group changes, p < 0.001). In the intervention group, higher MEDAS scores remained significantly associated with lower pain after accounting for body-weight change (β = -0.471, p= 0.005), whereas body-weight change was not significantly associated with final VAS score (β = 0.201, p= 0.208).
Conclusions: A 3-month Mediterranean diet-based intervention was associated with improvements in pain, central sensitisation-related symptoms and anthropometric and metabolic outcomes in women with lipedema. Larger randomised controlled trials with longer follow-up are warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An a priori sample size calculation was performed using G*Power. Based on the comparison of mean scale scores between two groups, assuming a medium effect size (d = 0.50), 90 % statistical power and a two-sided significance level of 5 %, a minimum total sample size of 46 participants (23 participants per group) was required. A total of 86 participants were enrolled in the study. Eligible participants were allocated sequentially to the intervention and control groups according to their order of presentation to the outpatient clinic. No randomisation procedure was used; participants were assigned alternately to the intervention and control groups as they were enrolled. During the follow-up period, nineteen participants did not complete the study.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Intervention | Experimental | Behavioral: Mediterranean Diet-Based Nutritional Intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women were eligible for inclusion if they had a clinical diagnosis of lipedema, were aged 19-64 years, and voluntarily agreed to participate in the study.
Key exclusion criteria (1 listed)
- Participants were excluded if they had a diagnosis of lymphedema, had previously undergone bariatric surgery, were pregnant or breastfeeding, or had experienced a ≥5% change in body weight during the preceding 6 months.
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 |
|---|---|---|
| Mediterranean Diet-Based Nutritional InterventionParticipants in the intervention group received an individualised, energy-restricted Mediterranean diet-based nutritional intervention for 3 months. Individual energy requirements were estimated using the Harris-Benedict equation, and dietary plans providing 1300-1500 kcal/day were prescribed. The diets provided approximately 35-40% of total energy from carbohydrates, 20-25% from protein and 35-40% from fat. The intervention emphasised vegetables, fruits, whole grains, legumes, nuts and olive oil as the principal source of added fat; encouraged regular consumption of fish and poultry; and limited red and processed meats, refined carbohydrates and added sugars. Participants attended monthly outpatient visits and received individual dietary plans electronically on a weekly basis. Adherence to the dietary intervention was reinforced and monitored through weekly telephone contacts. | Behavioural | Mediterranean Diet Intervention |
Primary outcome
Change in Pain Intensity Assessed by the Visual Analogue Scale
Time frame: Baseline, 1 month, 2 months, and 3 months
Pain intensity was assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Total and regional pain scores were assessed.
1 secondary outcome
Change in Central Sensitisation-Related Symptoms Assessed by the Central Sensitization Inventory
Time frame: Baseline, 1 month, 2 months, and 3 months
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 2 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet-Based Nutritional Intervention in people with Lipedema, run by Baskent University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 2 Oct 2026. 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 Turkey (Türkiye). 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 Assessed by the Visual Analogue Scale (time frame: Baseline, 1 month, 2 months, and 3 months). 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 2 Oct 2026.