ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women

Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence

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.

Proportion of Participants Persisting with Supplementation at Week 12

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.

Participant Satisfaction and Willingness to Continue Supplementation (Numeric Rating Scale and Yes/No Question)

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

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)

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.

Change in Handgrip Strength Measured by Dynamometry (kg)

Change in handgrip strength measured using a hand dynamometer (kg) between baseline and Week 12. Three consecutive measurements will be performed on the same hand, and the mean value (kg) will be calculated for each participant. Higher values indicate greater muscle strength.

Change in Joint Pain Measured by Visual Analog Scale (VAS, 0-10)

Change in perceived joint pain measured using a Visual Analog Scale (VAS; 0-10), where 0 indicates no pain and 10 indicates worst possible pain, between baseline and Week 12. Higher scores indicate greater pain.

Change in Body Composition Measured by Bioimpedance Analysis (Lean Mass, Fat Mass, Total Body Water, Protein, Skeletal Muscle Mass)

Change in body composition parameters assessed by bioimpedance analysis between baseline and Week 12, including lean mass (kg), fat mass (kg), total body water (%), protein mass (kg), and skeletal muscle mass (kg). Changes in these parameters will be analyzed descriptively, with higher lean mass, protein mass, skeletal muscle mass, and total body water, and lower fat mass, indicating improved body composition.

Change Cervantes Scale of Health-Related Quality of Life total score (0-40) and by domains

Change in quality of life assessed using the Cervantes Scale, a validated 31-item questionnaire specific for menopausal women. The questionnaire includes the following domains: menopause and health, psychological domain, sexuality, couple relationship, and vasomotor symptoms. Domain-specific scores and total score will be analyzed descriptively. Questionnaires with 3 or more missing items will be considered invalid; questionnaires with 1 or 2 missing items will be handled according to the correction rules specified in the instrument manual.