Prevention of Muscle Mass Loss
Conditions
Keywords
Supplement, Muscle mass
Brief summary
The objective of this study is to evaluate whether the supplement, combined with resistance training, prevents muscle mass loss during weight loss. The treatment will last four months and include clinical assessments, proper nutrition, and physical activity..
Interventions
DIETARY_SUPPLEMENTExperimental arm
Two doses, once a day.
DIETARY_SUPPLEMENTPlacebo
Two doses, once daily
Sponsors
Althaia S.A Industria Farmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants of both sexes aged between 25 and 60 years. * Ability to understand and accept participation in the study, indicated by signing the Informed Consent Form approved by the Ethics Committee. * Good health status, determined by the absence of significant findings in medical history, physical examination, laboratory tests, and vital sign measurements. * Agree to comply with the planned study procedures and attend visits. * Participants with the capacity and motivation to perform resistance training 3 to 5 times per week (150 to 200 minutes/week); - Participants with a body mass index (BMI) ≥ 27.0 kg/m².
Exclusion criteria
* Known allergy to components of the investigational product or placebo; * History of chronic use in the last 3 months or current use of medications or substances that affect the muscular system; * Current history of type 1 or 2 diabetes mellitus, gastrointestinal, cardiovascular, renal, or hepatic diseases, or malignant neoplasm, considered clinically significant at the physician's discretion. * Abuse of illicit drugs or alcohol, as clinically assessed by the investigator during screening. * Having participated in a clinical study in the last 12 months at the investigator's discretion. * Having any condition that prevents participation in the study at the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fat-free mass relative | 4 months | Change in fat-free mass relative to baseline after 120 days of treatment, assessed by electrical bioimpedance. |
| Evaluation of the supplement's effect on preventing muscle mass loss during weight loss. | From the screening visit to the end of treatment - 120 days | Change in baseline mass compared to 120 days of treatment. |
Countries
Brazil
Outcome results
None listed