The Effect of Mediterranean Diet on Pain Level and Biochemical Parameters in Women With Lipedema

NCT07853833 | Completed

• 1 other identifier: KA25/82
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lipedema

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, 2 months, and 3 months

Secondary Outcomes (1)

• Change in Central Sensitisation-Related Symptoms Assessed by the Central Sensitization Inventory

  Baseline, 1 month, 2 months, and 3 months

Other Outcomes (2)

• Change in Mediterranean Diet Adherence Assessed by MEDAS

  Baseline, 1 month, 2 months, and 3 months

• Changes in Anthropometric and Biochemical Parameters

  Baseline and 3 months

Study Arms (2)

Mediterranean Diet Intervention

EXPERIMENTAL

Behavioral: Mediterranean Diet-Based Nutritional Intervention

Control

NO INTERVENTION

Interventions

Mediterranean Diet-Based Nutritional Intervention BEHAVIORAL

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.

Mediterranean Diet Intervention

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Başkent Üniversity

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 2, 2026
• Study Start: May 1, 2025
• Primary Completion: January 29, 2026
• Study Completion: April 26, 2026
• Last Updated: October 2, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)