Lipedema Dietary Supplements
Conditions
Interventions
This is a randomized, prospective, parallel, placebo-controlled, double-blind clinical trial including 98 participants, with 49 allocated to the intervention group and 49 to the comparator group. Elig
Sponsors
Abralipedema Pro Organização de Ensino Ltda
Abralipedema Pro Organização de Ensino Ltda
Eligibility
Sex/Gender
Female
Age
25 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women aged greater than or equal to 25 years and less than or equal to 45 years; clinical diagnosis of lipedema stages II to III; regular menstrual cycles or medication-induced amenorrhea; regular physical activity practice greater than or equal to 150 minutes per week; body weight stability with variation less than or equal to 3 percent in the last 3 months; agreement to maintain dietary habits and physical activity level during the study; discontinuation of supplements that may interfere with muscle mass, such as protein supplements, creatine and branched-chain amino acids (BCAA); signing of the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: Pregnant women; breastfeeding women; women planning pregnancy; presence of symptoms or diagnosis of menopause; uncontrolled chronic diseases; relevant musculoskeletal or neuromuscular disorders; fractures within the last 12 months; performance of aesthetic surgeries or liposuction within the last 6 months; recent use of protein supplements or substances that affect body composition; use of medications that significantly interfere with body composition; allergy to supplement components; presence of eating disorders; severe psychiatric disorders; participation in another clinical study within the last 12 months; any condition that prevents adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of supplementation with bioactive collagen peptides on muscle mass gain and muscle strength in women with lipedema, assessed by bioimpedance and strength tests throughout the intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate secondary outcomes related to additional effects of the intervention, including muscle strength, tissue fibrosis, pain sensitivity, microcirculation, body composition, gastrointestinal events, and quality of life; assessed through dynamometry for muscle strength evaluation, B-mode ultrasonography for fibrosis analysis, algometry for pain threshold measurement, infrared thermography for microcirculation assessment, bioelectrical impedance and perimetry for body composition analysis, application of a specific questionnaire for gastrointestinal events, and validated questionnaires for quality of life; changes in the obtained values will be analyzed over time and between groups using method-specific units, including measurements in kilogram-force, centimeters, thermal patterns, echographic characteristics, and questionnaire scores at time points T0, T45, T90, and T120. | — |
Countries
BR
Contacts
Public ContactCamila Pacheco
Abralipedema Pro
Outcome results
None listed