Muscles
Conditions
Interventions
This is a national, single-center, randomized, double-blind clinical study to evaluate the benefits of oral administration of Hydrolyzed Collagen, with a parallel design between two groups and placebo
Sponsors
Centro de Medicina Reprodutiva Dr. Carlos Isaia Filho LTDA.
Centro de Medicina Reprodutiva Dr. Carlos Isaia Filho LTDA.
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy participants; female; aged between 18 and 45 years; able to confirm voluntary participation; agree with all the purposes of the trial by signing and dating the informed consent form in two copies; have a negative pregnancy test at the screening visit; have agreed to maintain their usual lifestyle regarding physical activities throughout the study; patients with a T-score of -2.5 standard deviations or higher in the bone densitometry result performed at screening; available to attend all study assessment visits
Exclusion criteria
Exclusion criteria: The participant must not have used collagen in the last 3 months; have current injuries, prolonged immobilizations, and/or pain in the musculoskeletal system (muscle, cartilage, or bone); have a recent history of surgery due to bone fracture; have any contraindications to functional food 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-blockers, or any medications that the evaluator deems may influence collagen metabolism; be pregnant, planning pregnancy, or lactating; have chronic cardiovascular, renal, hepatic, neurological, endocrine (including osteoporosis), metabolic, or infectious disease, or severe hematological disease; be 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 liquor per day) per week; be a participant with synovitis and synovial effusion in the knee; have gastrointestinal diseases that may affect collagen absorption; present any clinical findings (clinical/physical assessment) or pre-existing laboratory conditions that are interpreted by the investigator as a risk to the participant’s involvement in the clinical trial; be a participant using or planning to use prohibited medications and/or supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: Evaluate the efficacy of oral administration of the functional food composed of hydrolyzed collagen versus placebo on the integrated musculoskeletal system (muscle, cartilage, and bones) in healthy women aged 18 to 45 years after six months of continuous use. The outcome was assessed through bone densitometry to measure bone mineral density (g/cm²) in the lumbar spine (L1-L4), total hip, and femur regions, magnetic resonance imaging with a T2-weighted sequence to evaluate the condition of the cartilage according to the outerbridge scale (grades 0-4), and physical tests to assess muscle and joint function ;Outcome Found 1: Two statistically significant positive effects were observed in the integrated musculoskeletal system (muscle, cartilage, and bones) in healthy women aged 18 to 45 years after six months of continuous use. Bone densitometry of the L1-L4 region showed a significant improvement in bone density in the group that received collagen. Additionally, in the physical test, an improvement in maximal muscle strength was observed, measured using a dynamometer;Expected Outcome 2: Evaluate the safety and clinical tolerability of the functional food composed of hydrolyzed collagen over six months, through the analysis of adverse event reports;Outcome Found 2: It was observed that hydrolyzed collagen was safe and well-tolerated, as only one serious adverse event was reported, which was classified as unrelated to the investigational product. Furthermore, in general, the adverse events were characterized as non-serious and unrelated to the investigational product | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 3: Evaluate the efficacy of the functional food composed of hydrolyzed collagen on muscle throughout the study in healthy women aged 18 to 45 years through physical tests;Outcome Found 3: A statistically significant positive effect on muscle was observed in healthy women aged 18 to 45 years after six months of continuous use. The physical test, measured by the dynamometer, demonstrated an improvement in maximal muscle strength;Expected Outcome 4: Evaluate the effectiveness of the functional food composed of hydrolyzed collagen on bones throughout the study in healthy women aged 18 to 45 years through bone densitometry;Found Outcome 4: A statistically significant positive effect was observed in the muscles of healthy women aged 18 to 45 years after six months of continuous use. The L1-L4 score obtained through bone densitometry showed a significant difference in the collagen group. Other parameters, such as L1-L4 (g/cm²), total hip (g/cm²), hip score, femoral neck (g/cm²), and femoral neck score, did not show significant differences between visits;Expected Outcome 5: Evaluate the effectiveness of the functional food composed of hydrolyzed collagen on cartilage throughout the study in healthy women aged 18 to 45 years through magnetic resonance imaging and physical tests;Found Outcome 5: Participants in the collagen group exhibited lower outerbridge injury values measured through magnetic resonance imaging, representing an average reduction of 20% in the patella compared to the placebo, which showed an increase in the degree of injury. Physical tests did not show improvement in cartilage;Desfecho Esperado 6: Identificar possíveis eventos adversos relacionados com o uso da medicação teste através de ficha específica para registro de eventos adversos;Found Outcome 6: Only one serious adverse event was reported during the study period, which was classified as not related to the investigational product. Additionally, overall, the adverse events were chara | — |
Countries
Brazil
Contacts
Public ContactCarlos Isaia
Instituto Isaia
Outcome results
None listed