NCT07891936

Brief Summary

Healthy aging requires effective, accessible, and sustainable interventions capable of preserving functional capacity and preventing age-related decline. In this context, walking football has emerged as a safe, inclusive physical exercise modality with high adherence among older adults, demonstrating benefits for muscle health, metabolic profile, and psychosocial well-being. On the other hand, creatine monohydrate supplementation is backed by robust scientific evidence as a strategy to enhance exercise adaptations, promote muscle mass maintenance, and improve factors related to metabolic syndrome. The objective of this project is to evaluate the effects of creatine supplementation combined with regular walking football practice on muscle quality and metabolic profile in older adults, as well as to explore the underlying biological mechanisms using a cell culture-based experimental model. The ultimate goal is to determine the potential of this intervention to promote healthy longevity through functional, muscular, and metabolic indicators associated with healthspan. Specifically, the study will analyze the intervention's effects on body composition, physical fitness, and metabolic syndrome markers; evaluate its impact on psychosocial well-being, quality of life, and cognitive function; and investigate the molecular mechanisms related to muscle health, protection against oxidative stress, and the modulation of senescence using an ex vivo/in vitro model. The project will be carried out in two complementary phases. First, a longitudinal experimental study will be conducted in older adults participating in walking football programs and supplemented with creatine. Subsequently, skeletal muscle cultures will be exposed to conditioned sera obtained before and after the intervention to investigate its biological effects. This approach will integrate the evaluation of clinical efficacy with the study of the underlying mechanisms, generating applicable knowledge for designing personalized, sustainable, and cost-effective strategies to prevent sarcopenia and metabolic syndrome.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Dec 2027

First Submitted

Initial submission to the registry

October 1, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

October 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

8 months

First QC Date

October 1, 2026

Last Update Submit

October 16, 2026

Conditions

Keywords

Walking footballCreatine monohydratePhysical exerciseSarcopeniaMuscle quality

Outcome Measures

Primary Outcomes (1)

  • Muscle Quality

    It is defined as the capacity of skeletal muscle to generate strength relative to its mass, integrating both structural and functional aspects. It will be expressed as the ratio between the estimated 1-RM strength and muscle mass measured by dual-energy X-ray absorptiometry (DEXA)

    From enrollment to the end of treatment at 32 weeks

Secondary Outcomes (63)

  • Nutritional profile

    From enrollment to the end of treatment at 32 weeks

  • Body composition

    From enrollment to the end of treatment at 32 weeks

  • Body composition

    From enrollment to the end of treatment at 32 weeks

  • Body composition

    From enrollment to the end of treatment at 32 weeks

  • Body composition

    From enrollment to the end of treatment at 32 weeks

  • +58 more secondary outcomes

Other Outcomes (3)

  • Characterization variables (collected through interview and individual history)

    At enrollment time

  • Characterization variables (collected through interview and individual history)

    At enrollment time

  • Characterization variables (collected through interview and individual history)

    At enrollment time

Study Arms (1)

Creatine + Walking Football training Group

EXPERIMENTAL

Single-arm, prospective interventional trial with a within-subject (pre-post) design, where each participant serves as his or her own control.

Dietary Supplement: Monohydrate Creatine supplementation during Walking Football training

Interventions

Participants will be assessed at baseline, after 16 weeks of supervised Walking Football training, and again after a further 16 weeks of Walking Football combined with daily creatine monohydrate supplementation. This within-subject design allows each participant to serve as their own control when evaluating the effects of creatine supplementation beyond those attributable to Walking Football training alone.

Creatine + Walking Football training Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals over 50 years of age
  • Minimum physical activity level recommended by the World Health Organization (≥150 minutes of moderate-intensity activity or ≥75 minutes of vigorous-intensity activity per week)
  • Men and women with regular participation (≥2 times per week) in walking football training for at least 6 months
  • Voluntary acceptance to participate in the study after having read, understood, and signed the informed consent form.

You may not qualify if:

  • Presence of metabolic, neuromuscular, cardiovascular, or joint diseases that contraindicate moderate-to-vigorous physical activity and/or creatine supplementation
  • Current use of creatine nutritional supplements or other ergogenic compounds
  • Having any comprehension difficulties or presenting musculoskeletal alterations that influence the assessments
  • Being under pharmacological treatment that may alter muscle mass or function
  • Cognitive impairment or alteration that prevents following the protocol indications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Candow DG, Zello GA, Ling B, Farthing JP, Chilibeck PD, McLeod K, Harris J, Johnson S. Comparison of creatine supplementation before versus after supervised resistance training in healthy older adults. Res Sports Med. 2014;22(1):61-74. doi: 10.1080/15438627.2013.852088.

    PMID: 24392772BACKGROUND
  • Amiri E, Sheikholeslami-Vatani D. The role of resistance training and creatine supplementation on oxidative stress, antioxidant defense, muscle strength, and quality of life in older adults. Front Public Health. 2023 May 2;11:1062832. doi: 10.3389/fpubh.2023.1062832. eCollection 2023.

    PMID: 37206869BACKGROUND
  • Dobrowolski P, Prejbisz A, Kurylowicz A, Baska A, Burchardt P, Chlebus K, Dzida G, Jankowski P, Jaroszewicz J, Jaworski P, Kaminski K, Kaplon-Cieslicka A, Klocek M, Kukla M, Mamcarz A, Mastalerz-Migas A, Narkiewicz K, Ostrowska L, Sliz D, Tarnowski W, Wolf J, Wylezol M, Zdrojewski T, Banach M, Januszewicz A, Bogdanski P. Metabolic syndrome - a new definition and management guidelines: A joint position paper by the Polish Society of Hypertension, Polish Society for the Treatment of Obesity, Polish Lipid Association, Polish Association for Study of Liver, Polish Society of Family Medicine, Polish Society of Lifestyle Medicine, Division of Prevention and Epidemiology Polish Cardiac Society, "Club 30" Polish Cardiac Society, and Division of Metabolic and Bariatric Surgery Society of Polish Surgeons. Arch Med Sci. 2022 Aug 30;18(5):1133-1156. doi: 10.5114/aoms/152921. eCollection 2022. No abstract available.

    PMID: 36160355BACKGROUND
  • 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.

    PMID: 29138605BACKGROUND
  • Masfiah S, Kurnialandi A, Meij JJ, Maier AB. Definitions of healthspan: A systematic review. Ageing Res Rev. 2025 Sep;111:102806. doi: 10.1016/j.arr.2025.102806. Epub 2025 Jun 14.

    PMID: 40523529BACKGROUND
  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

    PMID: 30312372BACKGROUND
  • Oudot A, Martin C, Busseuil D, Vergely C, Demaison L, Rochette L. NADPH oxidases are in part responsible for increased cardiovascular superoxide production during aging. Free Radic Biol Med. 2006 Jun 15;40(12):2214-22. doi: 10.1016/j.freeradbiomed.2006.02.020. Epub 2006 Mar 23.

    PMID: 16785035BACKGROUND
  • Goddard G, Rajagopal S, Wahbah Makhoul G, Raji MA. Metabolic Syndrome in Older Adults: Through the Lens of Institute for Healthcare Improvement's (IHI) 4Ms Framework and Social Determinants of Health. Life (Basel). 2025 Aug 28;15(9):1370. doi: 10.3390/life15091370.

    PMID: 41010311BACKGROUND
  • Short KR, Vittone JL, Bigelow ML, Proctor DN, Nair KS. Age and aerobic exercise training effects on whole body and muscle protein metabolism. Am J Physiol Endocrinol Metab. 2004 Jan;286(1):E92-101. doi: 10.1152/ajpendo.00366.2003. Epub 2003 Sep 23.

    PMID: 14506079BACKGROUND

MeSH Terms

Conditions

Motor ActivitySarcopenia

Condition Hierarchy (Ancestors)

BehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Tamara Iturriaga Ramirez, PhD

    Facultad de Medicina, Salud y Deportes, Departamento de Ciencias del Deporte, Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamara Iturriaga Ramirez, PhD

CONTACT

Catalina Santiago Dorrego, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 1, 2026

First Posted

October 23, 2026

Study Start

October 20, 2026

Primary Completion (Estimated)

June 20, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share