An interventional study of Anti-inflammatory Diet and Physical Therapy and Standard Diet and Physical Therapy in Lipedema, sponsored by Balikesir University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Balikesir University · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the effectiveness of standard physical therapy methods (Complex Decongestive Therapy, Pneumatic Compression, and Exercise) combined with two different nutritional approaches (personalized anti-inflammatory diet vs. standard healthy nutrition education) in women diagnosed with lower extremity lipedema.
This single-center, prospective, single-blind, randomized controlled trial will include 75 female participants aged 18-65 with Stage I, II, or III lipedema. Participants will receive either a personalized anti-inflammatory diet or standard nutrition education, alongside a standard 12-week physical therapy protocol. Evaluations will be conducted at baseline, 4th, 8th, and 12th weeks to measure changes in lower extremity circumference/volume, body composition, ultrasonographic tissue characteristics, functional capacity (6MWT), pain severity (VAS), and quality of life.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 75 is above the median of 35 across 42 interventional studies indexed under Lipedema.
Browse Lipedema studies →Balikesir University is the lead sponsor of 62 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive a personalized anti-inflammatory diet plan formulated by the Physical Medicine and Rehabilitation clinic, in addition to a standard 12-week physical therapy protocol (Complex Decongestive Therapy, Intermittent Pneumatic Compression, and exercise).
Other: Anti-inflammatory Diet and Physical Therapy
Participants in this arm will receive standard healthy nutrition education, in addition to a standard 12-week physical therapy protocol (Complex Decongestive Therapy, Intermittent Pneumatic Compression, and exercise).
Other: Standard Diet and Physical Therapy
A personalized anti-inflammatory diet plan formulated by the clinic, combined with a 12-week standard physical therapy protocol. The physical therapy includes compression garments (CCL2), Manual Lymphatic Drainage (MLD), Intermittent Pneumatic Compression (IPC), and an exercise program.
Standard healthy nutrition education, combined with a 12-week standard physical therapy protocol. The physical therapy includes compression garments (CCL2), Manual Lymphatic Drainage (MLD), Intermittent Pneumatic Compression (IPC), and an exercise program.
Change in Lower Extremity Circumference
Lower extremity circumferences will be measured in centimeters (cm) using a standardized tape measure at predefined anatomical landmarks, including the foot dorsum, ankle, and at 10-cm intervals proximally below the knee, as well as at the thigh. Change in lower extremity circumference from baseline will be evaluated within and between study groups.
Time frame: Baseline, Week 6, and Week 12
Change in Body Weight
Body weight (kg) measured at each assessment visit using standardized equipment. Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Subcutaneous tissue thickness (mm)
Subcutaneous tissue thickness (mm) will be assessed via ultrasound at standardized anatomical landmarks (anterior thigh, inferomedial knee, lateral leg, pre-tibial, medial malleolus, and umbilical region). Both parameters are measured directly in millimeters (mm). Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Dermis thickness (mm)
Dermis thickness (mm) will be assessed via ultrasound at standardized anatomical landmarks (anterior thigh, inferomedial knee, lateral leg, pre-tibial, medial malleolus, and umbilical region). Both parameters are measured directly in millimeters (mm). Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Fibrous Septa Prominence
The prominence of fibrous septa within the subcutaneous tissue will be assessed by ultrasound at predefined lower-extremity anatomical landmarks using a visual scoring system ranging from 0 to 3. Higher scores indicate greater fibrotic septal prominence. Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Subcutaneous Fat Tissue Echogenicity
Subcutaneous fat tissue echogenicity will be assessed by ultrasound at predefined lower-extremity anatomical landmarks using a visual scoring system ranging from 0 to 3. Higher scores indicate greater echogenicity. Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Rectus Femoris Muscle Thickness
Rectus femoris muscle thickness will be measured by ultrasound in millimeters (mm) at a standardized anatomical site. Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Rectus Femoris Muscle Echogenicity
Rectus femoris muscle echogenicity will be assessed by ultrasound at a standardized anatomical site using a visual grading scale from Grade 1 to Grade 3. Higher grades indicate greater muscle echogenicity. Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Abdominal Subcutaneous Adipose Tissue Thickness
Abdominal subcutaneous adipose tissue thickness will be measured by ultrasound in millimeters (mm) at locations 5 cm above and 5 cm below the umbilicus. The mean of these two measurements will be used for analysis. Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Functional Capacity
Assessment of submaximal exercise capacity using the 6-Minute Walk Test (6MWT). The total distance walked in 6 minutes will be recorded in meters (m). A higher score indicates better functional capacity.
Time frame: Baseline, Week 6, and Week 12
Change in Pain Severity
Evaluation of leg pain intensity using the Visual Analog Scale (VAS). Scale range: 0 (no pain) to 10 (unbearable pain); lower scores indicate better outcome. Change from baseline will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Patient Benefit Index-Lymphedema (PBI-L) Score
The Patient Benefit Index-Lymphedema (PBI-L) is a patient-reported outcome measure used to assess the perceived benefit of treatment in individuals with lymphedema. It includes 23 items addressing treatment goals and the extent to which these goals have been achieved. Scores range from 0 to 4, with higher scores indicating greater patient-perceived treatment benefit. Change from baseline to the specified follow-up time point will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in LYMQOL-Leg Score
The LYMQOL-Leg is an 18-item, lymphedema-specific quality-of-life questionnaire for patients with lower-limb lymphedema. It assesses the impact of lymphedema across relevant quality-of-life domains. Domain scores range from 1 to 4, with lower scores indicating a better outcome and less lymphedema-related impairment. Change from baseline to the specified follow-up time point will be assessed.
Time frame: Baseline, Week 6, and Week 12
Change in SF-12 Physical Component Summary Score
The 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) score assesses physical health status, including physical functioning, role limitations due to physical health, bodily pain, and general health perceptions. Scores range from 0 to 100, with higher scores indicating better physical health status. Change from baseline to the specified follow-up time point will be analyzed.
Time frame: Baseline, Week 6, and Week 12
Change in SF-12 Mental Component Summary Score
The SF-12 Mental Component Summary (MCS) score assesses mental health status, including psychological well-being, emotional role functioning, social functioning, and vitality. Scores range from 0 to 100, with higher scores indicating better mental health status. Change from baseline to the specified follow-up time point will be evaluated.
Time frame: Baseline, Week 6, and Week 12
Change in Beck Depression Inventory Score
The Beck Depression Inventory (BDI) is a 21-item self-report questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with lower scores indicating fewer depressive symptoms. Change from baseline to the specified follow-up time point will be assessed, with a decrease in score indicating improvement.
Time frame: Baseline, Week 6, and Week 12
Plan to share: No
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