MenopauseATENEANCT07580846
ATENEA Study: Adherence to Creatine-Based Nutritional Supplementation in Estrogen-Depleted Women
An observational study of Menopause and Estrogen Deficiency, run by Margan Biotech at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Estrogen Deficiency
- How many people
- 100 participants
- Where
- 4 sitesSpain
- Study dates
- 20 Mar 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Estrogen-depleted adult women (menopause or late perimenopause) attending routine clinical practice consultations in participating centers and initiating nutritional supplementation.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Recruiting
Clínica Palacios
Madrid, Madrid, 28034
Santiago Palacios, Doctor, +34915780517, santiago.palacios@clinicapalacios.com
Santiago Palacios, Doctor
- Recruiting
Menoclinica by Palacios
Madrid, Madrid, 28034
Silvia P González, Doctor, +34 914 32 44 99, silviapgonzalez@yahoo.es
Silvia P Gonzalez, Doctor
- Recruiting
Ginegetafe
Madrid, Madrid, 28901
Carmen Pingarron, Doctor, +34 915 78 05 17, cpingarrons@gmail.com
Carmen Pingarron, Doctor
- Not yet recruiting
Clinica Palacios Málaga
Málaga, Málaga, 29016
Rodrigo Orozco, Doctor, +34 951 55 63 76, rodrigo.orozco@quironsalud.es
Rodrigo Orozco, Doctor
About this study
Official title: AssessmenT of thE Adherence of Nutritional Supplementation With Creatine Formula in Estrogen-Depleted Adult Women: Prospective Clinical Investigation
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.
Read the 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.
- Conditions
- Menopause, Estrogen Deficiency
- Keywords
- Creatine, Menopause, Women´s Health, Estrogen deficiency, Collagen, Dietary supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start20 Mar 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Margan Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silvia P Gonzalez, Doctor, Study director, Menoclinica by Palacios
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580846
- Sponsor's protocol ID
- ATENEA
- Acronym
- ATENEA
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study was not designed with a formal data-sharing plan, and appropriate governance mechanisms for external data access have not been established.
Publications
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.
PubMed 36615817Erdelyi 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.
PubMed 38201856Parra 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.
PubMed 30037155Roche 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.
PubMed 33494277Larrosa 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.
PubMed 38994896Saunders 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.
PubMed 27797728de 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.
PubMed 39886281Bakian 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.
PubMed 32066709Allen 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.
PubMed 22465051Forbes 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.
PubMed 34788768Sales 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.
PubMed 31257405Smith-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.
PubMed 33800439Chilibeck 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.
PubMed 29138605Chilibeck 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.
PubMed 25386713de 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.
PubMed 32549301
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssessmenT of thE Adherence of Nutritional Supplementation With Creatine Formula in Estrogen-Depleted Adult Women: Prospective Clinical Investigation
- ClinicalTrials.gov ID
- NCT07580846
- Acronym / sponsor ID
- ATENEA / ATENEA
- Conditions
- Menopause, Estrogen Deficiency
- Keywords
- Creatine, Menopause, Women´s Health, Estrogen deficiency, Collagen, Dietary supplements
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Margan BiotechIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Estrogen-depleted adult women (menopause or late perimenopause) attending routine clinical practice consultations in participating centers and initiating nutritional supplementation.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence
Time frame: 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.
4 secondary outcomes
Proportion of Participants Persisting with Supplementation at Week 12
Time frame: 12 weeks
Participant Satisfaction and Willingness to Continue Supplementation (Numeric Rating Scale and Yes/No Question)
Time frame: 12 weeks
Number of Participants With Adverse Events Related or Unrelated to Supplementation
Time frame: 12 weeks
Adherence to Recommended Physical Activity (Daily Self-Reported Exercise Log)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 36615817Feduniw 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.
- Background: PubMed 38201856Erdelyi 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.
- Background: PubMed 30037155Parra 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.
- Background: PubMed 33494277Roche 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.
- Background: PubMed 38994896Larrosa 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.
- Background: PubMed 27797728Saunders 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.
- Background: PubMed 39886281de 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.
- Background: PubMed 32066709Bakian 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.
- Background: PubMed 22465051Allen 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.
- Background: PubMed 34788768Forbes 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.
- Background: PubMed 31257405Sales 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.
- Background: PubMed 33800439Smith-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.
- EFSA statement Beta-alanineLink provided by the sponsor.
- AESAN statement CreatineLink provided by the sponsor.
- Magnesium bisglicinate NIHLink provided by the sponsor.
- Individual participant dataSharing planned: No. The study was not designed with a formal data-sharing plan, and appropriate governance mechanisms for external data access have not been established.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia P Gonzalez, Doctor study director
Menoclinica by Palacios
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Estrogen Deficiency, run by Margan Biotech at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Martinez (+34606441146, silvia.martinez@marganbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07580846, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.