Estrogen Deficiency, Menopause
Conditions
Keywords
Creatine, Menopause, Women´s Health, Estrogen deficiency, Collagen, Dietary supplements
Brief summary
This is a prospective, multicenter, observational clinical study conducted under routine clinical practice conditions aimed at describing adherence to a creatine-based nutritional supplement (Creaticare FEM) in estrogen-depleted adult women. Participants will receive the supplement for 12 weeks, and adherence will be assessed as the percentage of doses consumed and the proportion of participants achieving ≥80% adherence. Secondary outcomes include persistence, satisfaction, tolerability, and adherence to recommended physical activity. Exploratory outcomes include changes in muscle strength, body composition, quality of life, joint pain, and skin health.
Detailed description
This is a prospective, multicenter, observational clinical study aimed at evaluating adherence to a creatine-based nutritional supplementation (Creaticare FEM) in estrogen-depleted adult women, including those in menopause or late perimenopause. Creaticare FEM is a multi-ingredient dietary supplement formulated to support musculoskeletal, metabolic, and skin health in this population. The daily dose (10 g) contains creatine monohydrate (3 g), hydrolyzed collagen (5 g), hyaluronic acid (95 mg), beta-alanine (300 mg), magnesium (200 mg), and vitamins A, C, E, and B6. Participants will receive the nutritional supplement for a period of 12 weeks, without any modification of standard clinical practice. The primary objective is to describe adherence to supplementation, defined as the percentage of prescribed doses consumed during the study period and the proportion of participants achieving high adherence (≥80%) at the end of follow-up. Secondary objectives include the assessment of persistence with supplementation, participant-reported acceptability and satisfaction, tolerability through the monitoring of adverse events, and adherence to a general recommendation of physical activity provided as part of routine care. In addition, exploratory analyses will be performed to describe pre-post changes over the 12-week period in selected clinical variables, including muscle strength (handgrip dynamometry), body composition (bioimpedance), quality of life (Cervantes questionnaire), joint pain (visual analog scale), and skin health perception (cosmetic VAS). These exploratory outcomes are descriptive in nature and intended to generate hypotheses for future controlled studies. The study does not involve randomization, control group, or experimental intervention beyond routine supplementation, and therefore is not intended to establish causal relationships or confirm clinical efficacy, but rather to provide real-world evidence on adherence, acceptability, and tolerability of a multimodal nutritional supplement in this population.
Interventions
None listed
Sponsors
Margan Biotech
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Biological female sex. * Age ≥40 years. * Estrogen-depleted status, defined as at least one of the following: natural menopause, defined as amenorrhea for ≥12 consecutive months; surgically induced menopause; late perimenopause with elevated FSH according to clinical judgment. * Absence of major comorbidities that would contraindicate use of the nutritional supplement or the recommended physical activity. * No relevant changes in usual treatment during the previous 3 months. * Ability to understand the study information and provide written informed consent. * Willingness to take the nutritional supplement according to the study instructions. * Willingness to follow general physical activity recommendations provided by the investigator. * Willingness and ability to attend the planned visits and complete study assessments through Week 12.
Exclusion criteria
* Initiation or modification of treatment with GLP-1 receptor agonists within the previous 12 weeks. * Presence of musculoskeletal or joint conditions that significantly limit the ability to perform regular physical activity or study-related functional assessments. * Clinically relevant renal or hepatic disease. * Current use of diuretics or potentially nephrotoxic medications. * Known allergy or intolerance to any component of the nutritional supplement. * Participation in another clinical study (nutritional, pharmacological, or interventional) within the previous 3 months. * Any medical condition or social circumstance that, in the investigator's judgment, could interfere with study participation, adherence, or data validity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence | 12 weeks | Adherence to supplementation assessed as the percentage of prescribed doses consumed during the 12-week study period, based on participant self-reported daily supplementation logs. Adherence will be expressed as a continuous variable (0-100%). In addition, the proportion of participants achieving ≥80% adherence at Week 12 will be calculated. Higher values indicate greater adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction and Willingness to Continue Supplementation (Numeric Rating Scale and Yes/No Question) | 12 weeks | Participant-reported satisfaction assessed using a numeric rating scale from 0 to 10, where 0 indicates no satisfaction and 10 indicates maximum satisfaction. Willingness to continue supplementation is assessed using a binary (yes/no) question. Summary measures will include mean satisfaction scores and the proportion of participants willing to continue supplementation. |
| Number of Participants With Adverse Events Related or Unrelated to Supplementation | 12 weeks | Number of participants reporting adverse events during the 12-week study period, including the type of event, severity, and investigator-assessed relationship to supplementation. Adverse events will be summarized by frequency and percentage of participants affected. |
| Adherence to Recommended Physical Activity (Daily Self-Reported Exercise Log) | 12 weeks | Adherence to recommended physical activity assessed using a study-specific daily self-reported exercise log, in which participants record the performance (yes/no) of strength exercise (30 minutes), aerobic exercise (30 minutes), and stretching (5 minutes) on a daily basis. Adherence will be calculated as the proportion of days in which recommended activities are performed over the study period (0-100%), where higher values indicate greater adherence to physical activity recommendations. |
| Proportion of Participants Persisting with Supplementation at Week 12 | 12 weeks | Persistence with supplementation defined as the proportion of participants who continue taking the supplement until the end of the study period (Week 12). Results will be expressed as the percentage of participants who remain on supplementation. Reasons for discontinuation will be recorded and summarized descriptively. |
Countries
Spain
Contacts
CONTACTSilvia Martinez
STUDY_DIRECTORSilvia P Gonzalez, Doctor
Menoclinica by Palacios
Outcome results
None listed