ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women (ATENEA)
AssessmenT of thE Adherence of Nutritional Supplementation With Creatine Formula in Estrogen-Depleted Adult Women: Prospective Clinical Investigation
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Silvia Martinez
- Telefonní číslo: +34606441146
- E-mail: silvia.martinez@marganbiotech.com
Studijní místa
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Madrid
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Madrid, Madrid, Španělsko, 28034
- Nábor
- Clínica Palacios
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Kontakt:
- Santiago Palacios, Doctor
- Telefonní číslo: +34915780517
- E-mail: santiago.palacios@clinicapalacios.com
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Vrchní vyšetřovatel:
- Santiago Palacios, Doctor
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Dílčí vyšetřovatel:
- Raquel Miguel, Doctor
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Madrid, Madrid, Španělsko, 28034
- Nábor
- Menoclinica by Palacios
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Kontakt:
- Silvia P González, Doctor
- Telefonní číslo: +34 914 32 44 99
- E-mail: silviapgonzalez@yahoo.es
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Vrchní vyšetřovatel:
- Silvia P Gonzalez, Doctor
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Dílčí vyšetřovatel:
- Esmeralda Josa, Nutritionist
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Madrid, Madrid, Španělsko, 28901
- Nábor
- Ginegetafe
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Kontakt:
- Carmen Pingarron, Doctor
- Telefonní číslo: +34 915 78 05 17
- E-mail: cpingarrons@gmail.com
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Vrchní vyšetřovatel:
- Carmen Pingarron, Doctor
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Vrchní vyšetřovatel:
- Silvia Poyo, Doctor
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Málaga
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Málaga, Málaga, Španělsko, 29016
- Zatím nenabíráme
- Clinica Palacios Málaga
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Kontakt:
- Rodrigo Orozco, Doctor
- Telefonní číslo: +34 951 55 63 76
- E-mail: rodrigo.orozco@quironsalud.es
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Vrchní vyšetřovatel:
- Rodrigo Orozco, Doctor
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Creatine-based nutritional supplement
Single prospective cohort of estrogen-depleted adult women (menopause or late perimenopause) receiving a creatine-based nutritional supplement for 12 weeks under routine clinical practice conditions. Participants take a daily dose of the supplement (10 g), which contains creatine monohydrate, hydrolyzed collagen, hyaluronic acid, beta-alanine, magnesium, and vitamins A, C, E, and B6. In addition, participants receive general recommendations for physical activity (including strength and aerobic exercise) consistent with standard clinical advice, without supervised training or structured intervention. The study does not include randomization, control group, or experimental assignment, as it aims to evaluate adherence, acceptability, and tolerability of nutritional supplementation in a real-world setting. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence
Časové okno: 12 weeks
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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. |
12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of Participants Persisting with Supplementation at Week 12
Časové okno: 12 weeks
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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.
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12 weeks
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Participant Satisfaction and Willingness to Continue Supplementation (Numeric Rating Scale and Yes/No Question)
Časové okno: 12 weeks
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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.
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12 weeks
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Number of Participants With Adverse Events Related or Unrelated to Supplementation
Časové okno: 12 weeks
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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.
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12 weeks
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Adherence to Recommended Physical Activity (Daily Self-Reported Exercise Log)
Časové okno: 12 weeks
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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.
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12 weeks
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Handgrip Strength Measured by Dynamometry (kg)
Časové okno: Baseline to Week 12
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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.
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Baseline to Week 12
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Change in Joint Pain Measured by Visual Analog Scale (VAS, 0-10)
Časové okno: Baseline to Week 12
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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.
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Baseline to Week 12
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Change in Body Composition Measured by Bioimpedance Analysis (Lean Mass, Fat Mass, Total Body Water, Protein, Skeletal Muscle Mass)
Časové okno: Baseline to Week 12
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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.
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Baseline to Week 12
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Change Cervantes Scale of Health-Related Quality of Life total score (0-40) and by domains
Časové okno: Baseline to Week 12
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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. |
Baseline to Week 12
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Change in Skin Health Perception Measured by Visual Analog Scale (VAS, 0-10)
Časové okno: Baseline to Week 12
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Change in perceived skin health assessed using a Visual Analog Scale (VAS; 0-10) evaluating multiple domains, including skin hydration and comfort, luminosity and overall appearance, anti-aging perception, and overall perceived efficacy. Each domain is scored from 0 to 10, where 0 indicates the worst perception and 10 indicates the best perception. Higher scores indicate better perceived skin health. Summary measures will include mean scores for each domain. |
Baseline to Week 12
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Silvia P Gonzalez, Doctor, Menoclinica by Palacios
Publikace a užitečné odkazy
Obecné publikace
- Allen PJ. Creatine metabolism and psychiatric disorders: Does creatine supplementation have therapeutic value? Neurosci Biobehav Rev. 2012 May;36(5):1442-62. doi: 10.1016/j.neubiorev.2012.03.005. Epub 2012 Mar 24.
- Chilibeck PD, Kaviani M, Candow DG, Zello GA. Effect of creatine supplementation during resistance training on lean tissue mass and muscular strength in older adults: a meta-analysis. Open Access J Sports Med. 2017 Nov 2;8:213-226. doi: 10.2147/OAJSM.S123529. eCollection 2017.
- Bakian AV, Huber RS, Scholl L, Renshaw PF, Kondo D. Dietary creatine intake and depression risk among U.S. adults. Transl Psychiatry. 2020 Feb 3;10(1):52. doi: 10.1038/s41398-020-0741-x.
- Wyss M, Kaddurah-Daouk R. Creatine and creatinine metabolism. Physiol Rev. 2000 Jul;80(3):1107-213. doi: 10.1152/physrev.2000.80.3.1107.
- Feduniw S, Korczynska L, Gorski K, Zgliczynska M, Baczkowska M, Byrczak M, Kociuba J, Ali M, Ciebiera M. The Effect of Vitamin E Supplementation in Postmenopausal Women-A Systematic Review. Nutrients. 2022 Dec 29;15(1):160. doi: 10.3390/nu15010160.
- Erdelyi A, Palfi E, Tuu L, Nas K, Szucs Z, Torok M, Jakab A, Varbiro S. The Importance of Nutrition in Menopause and Perimenopause-A Review. Nutrients. 2023 Dec 21;16(1):27. doi: 10.3390/nu16010027.
- Parra M, Stahl S, Hellmann H. Vitamin B(6) and Its Role in Cell Metabolism and Physiology. Cells. 2018 Jul 22;7(7):84. doi: 10.3390/cells7070084.
- Roche FC, Harris-Tryon TA. Illuminating the Role of Vitamin A in Skin Innate Immunity and the Skin Microbiome: A Narrative Review. Nutrients. 2021 Jan 21;13(2):302. doi: 10.3390/nu13020302.
- Larrosa M, Gil-Izquierdo A, Gonzalez-Rodriguez LG, Alferez MJM, San Juan AF, Sanchez-Gomez A, Calvo-Ayuso N, Ramos-Alvarez JJ, Fernandez-Lazaro D, Lopez-Grueso R, Lopez-Leon I, Moreno-Lara J, Dominguez-Balmaseda D, Illescas-Quiroga R, Cuenca E, Lopez T, Montoya JJ, Rodrigues-de-Souza DP, Carrillo-Alvarez E, Casado A, Rodriguez-Donate B, Porta-Oliva M, Santiago C, Iturriaga T, De Lucas B, Solaesa AG, Montero-Lopez MDP, Benitez De Gracia E, Veiga-Herreros P, Munoz-Lopez A, Orantes-Gonzalez E, Barbero-Alvarez JC, Cabeza-Ruiz R, Carnero-Diaz A, Sospedra I, Fernandez-Galvan LM, Martinez-Sanz JM, Martin-Almena FJ, Perez M, Guerra-Hernandez EJ, Lopez-Samanes A, Sanchez-Oliver AJ, Dominguez R. Nutritional Strategies for Optimizing Health, Sports Performance, and Recovery for Female Athletes and Other Physically Active Women: A Systematic Review. Nutr Rev. 2025 Mar 1;83(3):e1068-e1089. doi: 10.1093/nutrit/nuae082.
- Saunders B, Elliott-Sale K, Artioli GG, Swinton PA, Dolan E, Roschel H, Sale C, Gualano B. beta-alanine supplementation to improve exercise capacity and performance: a systematic review and meta-analysis. Br J Sports Med. 2017 Apr;51(8):658-669. doi: 10.1136/bjsports-2016-096396. Epub 2016 Oct 18.
- de Carvalho JF, Davidson J. Oral Hyaluronic Acid in Osteoarthritis and Low Back Pain: A Systematic Review. Mediterr J Rheumatol. 2024 Dec 31;35(4):557-562. doi: 10.31138/mjr.240724.oha. eCollection 2024 Dec.
- Forbes SC, Ostojic SM, Souza-Junior TP, Candow DG. A High Dose of Creatine Combined with Resistance Training Appears to Be Required to Augment Indices of Bone Health in Older Adults. Ann Nutr Metab. 2022;78(3):183-186. doi: 10.1159/000520967. Epub 2021 Nov 17. No abstract available.
- Sales LP, Pinto AJ, Rodrigues SF, Alvarenga JC, Goncalves N, Sampaio-Barros MM, Benatti FB, Gualano B, Rodrigues Pereira RM. Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):931-938. doi: 10.1093/gerona/glz162.
- Smith-Ryan AE, Cabre HE, Eckerson JM, Candow DG. Creatine Supplementation in Women's Health: A Lifespan Perspective. Nutrients. 2021 Mar 8;13(3):877. doi: 10.3390/nu13030877.
- Chilibeck PD, Candow DG, Landeryou T, Kaviani M, Paus-Jenssen L. Effects of Creatine and Resistance Training on Bone Health in Postmenopausal Women. Med Sci Sports Exerc. 2015 Aug;47(8):1587-95. doi: 10.1249/MSS.0000000000000571.
- de Guingand DL, Palmer KR, Snow RJ, Davies-Tuck ML, Ellery SJ. Risk of Adverse Outcomes in Females Taking Oral Creatine Monohydrate: A Systematic Review and Meta-Analysis. Nutrients. 2020 Jun 15;12(6):1780. doi: 10.3390/nu12061780.
- Smith-Ryan AE, DelBiondo GM, Brown AF, Kleiner SM, Tran NT, Ellery SJ. Creatine in women's health: bridging the gap from menstruation through pregnancy to menopause. J Int Soc Sports Nutr. 2025 Dec;22(1):2502094. doi: 10.1080/15502783.2025.2502094. Epub 2025 May 15.
- Persky AM, Brazeau GA. Clinical pharmacology of the dietary supplement creatine monohydrate. Pharmacol Rev. 2001 Jun;53(2):161-76.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- ATENEA
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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