Lipedema, chronic pain Adipose Tissue
Conditions
Interventions
Randomized, double-blind, placebo-controlled clinical trial with three parallel groups. Participants will receive daily oral supplementation for 60 days with placebo, 50 mg sustained-release trans-res
Sponsors
Abralipedema Pro Organização de Ensino Ltda
SM Empreendimentos Farmacêuticos Ltda. – Fagron Brasil
Eligibility
Sex/Gender
Female
Age
35 Years to 50 Years
Inclusion criteria
Inclusion criteria: Women aged 35 to 50 years; clinical diagnosis of stage II or III lipedema; lipedema-related pain with a Visual Analog Scale (VAS) score of 5 or higher; stable clinical condition during the previous three months; no use of resveratrol-containing supplements or compounds with potential anti-inflammatory effects within the previous 30 days; willingness to maintain usual lifestyle habits throughout the study; ability to understand and complete study assessments; provision of written informed consent
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding; rheumatologic diseases, fibromyalgia, or active autoimmune diseases; continuous use of analgesics, anti-inflammatory drugs, or corticosteroids within the previous 30 days; recent surgical, aesthetic, or intensive physiotherapy interventions for lipedema within the previous three months; diagnosis of lipo-lymphedema; uncontrolled metabolic diseases; cognitive or psychiatric conditions that impair study comprehension; known allergy or intolerance to study product components; participation in another clinical trial within the previous three months; inability to attend study visits or comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe a reduction in lipedema-related symptoms, pain intensity and improvement in the evaluated clinical parameters after 60 days of intervention with trans-resveratrol, particularly among participants receiving the higher supplementation doses | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe changes in self-reported pain intensity assessed by the Visual Analog Scale (VAS), qualitative pain characteristics assessed by the McGill Pain Questionnaire, pressure pain threshold assessed by algometry, cutaneous sensitivity assessed by esthesiometry, local temperature and perfusion patterns assessed by infrared thermography, quality of life assessed by the Short Form Health Survey (SF-36), chronic pain acceptance assessed by the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), as well as treatment adherence, safety and tolerability of the intervention between baseline (T0) and 60 days of intervention (T60), comparing the placebo, 50 mg trans-resveratrol and 100 mg trans-resveratrol groups | — |
Countries
BR
Contacts
Public ContactPaula de Souza
Abralipedema Pro
Outcome results
None listed