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COMPLETED
NCT07853833
NA

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

Sponsor: Baskent University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

19 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2025-05-01

Completion Date

2026-04-26

Last Updated

2026-10-02

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Mediterranean Diet-Based Nutritional Intervention

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.

Locations (1)

Başkent Üniversity

Ankara, Turkey (Türkiye)