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

Official title

AssessmenT of thE Adherence of Nutritional Supplementation With Creatine Formula in Estrogen-Depleted Adult Women: Prospective Clinical Investigation

Overview

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.

Primary outcome measures

• Adherence to Nutritional Supplementation Measured as Percentage of Prescribed Doses Consumed and Proportion of Participants Achieving ≥80% Adherence [Time frame: 12 weeks]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Spain · 4 centers

• Clínica Palacios — Madrid
• Menoclinica by Palacios — Madrid
• Ginegetafe — Madrid
• Clinica Palacios Málaga — Málaga

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. PMID 36615817
• 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. PMID 38201856
• 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. PMID 30037155
• 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. PMID 33494277
• 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 A PMID 38994896
• 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. PMID 27797728
• 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. PMID 39886281
• 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. PMID 32066709

Identifiers

NCT: NCT07580846 · ATENEA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗