Muscles
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. A total of 72 participants met the eligibility criteria and were randomly assigned to one of the intervention groups using a rand
G07.203.300.456
Sponsors
Centro de Medicina Reprodutiva Dr. Carlos Isaia Filho LTDA.
Centro de Medicina Reprodutiva Dr. Carlos Isaia Filho LTDA.
Eligibility
Sex/Gender
Female
Age
45 Years to 60 Years
Inclusion criteria
Inclusion criteria: Healthy female participants; aged between 45 and 60 years; with the ability to confirm voluntary participation and agree with all the purposes of the trial by signing and dating the informed consent form in two copies; willing to maintain their usual physical activity lifestyle until the end of the study; patients with a T-score of -2.5 standard deviations or higher in the result of bone densitometry performed during screening (V-1); availability to attend all study evaluation visits; postmenopausal participants with documented evidence; if the participant has not undergone a hysterectomy: at least 12 months of spontaneous amenorrhea; if the participant has undergone oophorectomy: at least 6 weeks post-bilateral oophorectomy procedure; if the participant has undergone a hysterectomy: serum FSH greater than 40 mUI/ml and E2 less than 20 pg/ml
Exclusion criteria
Exclusion criteria: Volunteers who have used collagen in the last 3 months; have undergone unilateral oophorectomy; have current injuries, prolonged immobilizations, and/or pain in the musculoskeletal system (muscle, cartilage, or bone); have a recent history of bone fracture surgery; have any contraindication to functional foods or intolerance to any of the experimental components or placebo; have a past or present history of malignant disease; have received intra-articular injections such as hyaluronic acid, corticosteroids, or similar in the last 6 months; have used glucosamine with or without chondroitin sulfate in the last 6 months; regularly use anti-inflammatory drugs, statins, beta-adrenergic blockers, or any drugs the investigator deems may influence collagen metabolism; have chronic cardiovascular, renal, hepatic, neurological, endocrine (including osteoporosis), metabolic, or infectious diseases, or severe hematological disorders; are vegan (due to the origin of the supplement to be used); consume more than 21 units of alcohol (equivalent to 1 glass of wine, 1 can of beer, or 1 shot of distilled alcohol per day) per week; participants with synovitis and synovial effusion in the knee; have gastrointestinal diseases that may affect collagen absorption; present any clinical findings (clinical/physical evaluation) or previous laboratory condition interpreted by the principal investigator as a risk to the participant's involvement in the clinical trial; participants using or with plans to use prohibited medications and/or supplements that are interpreted by the principal investigator as a risk to the participant's involvement in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: To assess whether the oral administration of a functional food composed of Hydrolyzed Collagen versus Placebo is effective in the integrated musculoskeletal system of healthy postmenopausal women aged 45 to 60 years after six months of continuous use, through bone densitometry examination, magnetic resonance imaging of the hyaline cartilage of the knee (patellar) with T2-weighted sequence, and a series of physical tests;Outcome found 1: A 15% increase in muscle strength and function, joint mobility, and balance was observed through a physical test. The other parameters evaluated did not show a statistically significant difference when compared to the placebo group;Expected Outcome 2: To assess the safety and clinical tolerability of Hydrolyzed Collagen during the six-month period through the adverse events reported in the adverse event report form;Outcome found 2: Through the analysis of the adverse event report form, only one serious adverse event was reported, which was considered unrelated to the investigational product. The other reported events were considered non-serious and unrelated to the investigational product. Therefore, the investigational product demonstrated to be safe and well tolerated | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 3: To evaluate the effectiveness of the functional food composed of Hydrolyzed Collagen on muscle throughout the study in healthy postmenopausal women aged 45 to 60 years, through specific physical tests that measure the maximum strength level using a dynamometer and assess the process of sitting down and standing up from the floor ;Outcome found 3: A 15% increase in muscle strength and function was observed through the physical test assessing the process of sitting down and standing up from the floor. The analysis of data obtained through the dynamometer did not show significant improvement;Expected Outcome 4: To evaluate the effectiveness of the functional food composed of Hydrolyzed Collagen on bones throughout the study in healthy postmenopausal women aged 45 to 60 years through bone densitometry examination;Outcome found 4: No statistically significant improvement was observed in any parameter assessed by bone densitometry between the groups. However, most parameters presented low p-values;Expected Outcome 5: To evaluate the effectiveness of the functional food composed of Hydrolyzed Collagen on cartilage throughout the study in healthy postmenopausal women aged 45 to 60 years through magnetic resonance imaging of the hyaline cartilage of the knee (patellar) with T2-weighted sequence and the sitting and standing physical test;Outcome found 5: A 15% increase in joint mobility and balance was observed through the physical test assessing the process of sitting down and standing up from the floor. The results observed through magnetic resonance imaging did not show statistically significant improvement; however, the collagen group exhibited a reduction in injury values of 27% in the patella, 30% in the trochlea, 50% in the medial condyle, and 33% in the medial tibial plateau, while the placebo group showed minimal to no reductions in the same parameters;Expected Outcome 6: To identify potential adverse events related to the use of the investigati | — |
Countries
Brazil
Contacts
Public ContactCarlos Isaia
Instituto Isaia
Outcome results
None listed