An interventional study of Monohydrate Creatine supplementation during Walking Football training in Muscle Adaptation, Body Composition and Physical Activity in Adults, sponsored by Universidad Europea de Madrid. Not yet recruiting. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Universidad Europea de Madrid · Not applicable, Interventional, and Other
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.
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This study's planned enrollment of 20 is below the median of 60 across 2,309 interventional studies indexed under Motor Activity.
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Exclusion Criteria:
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
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.
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)
Time frame: From enrollment to the end of treatment at 32 weeks
Nutritional profile
This will be assessed through a nutritional interview conducted by a professional, which will include a complete dietary history, a 24-hour dietary recall (24hR), and a food frequency questionnaire (FFQ)
Time frame: From enrollment to the end of treatment at 32 weeks
Body composition
assessed through basic anthropometry: weight in kilogram (kg)
Time frame: From enrollment to the end of treatment at 32 weeks
Body composition
assessed through basic anthropometry: height in centimeter (cm)
Time frame: From enrollment to the end of treatment at 32 weeks
Body composition
assessed through basic anthropometry: body mass index (BMI), weight and height will be combined to report BMI in kg/m\^2
Time frame: From enrollment to the end of treatment at 32 weeks
Body composition
Dual X-Ray Densitometry: body adiposity index, (BAI) in perctange (%)
Time frame: From enrollment to the end of treatment at 32 weeks
Body composition
Dual X-Ray Densitometry: fat mass index (FMI) kilograms per square meter. kg/m²
Time frame: From enrollment to the end of treatment at 32 weeks
Body composition
Dual X-Ray Densitometry: visceral adipose tissue area, VAT Area in square centimeter (cm²)
Time frame: From enrollment to the end of treatment at 32 weeks
Body composition
Dual X-Ray Densitometry: skeletal muscle mass index, (SMI) kilograms per square meter. kg/m²
Time frame: From enrollment to the end of treatment at 32 weeks
Body composition
Dual X-Ray Densitometry: appendicular skeletal muscle mass index, (ASM). kilograms per square meter. kg/m²
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): VO2 max (L/min) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Relative VO2 (ml/kg/min) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Absolute VO2 (L/min) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Absolute VCO2 (L/min) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Respiratory exchange ratio, RER in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Ventilatory equivalent, rate of ventilation and absolute O2 (VE/O2) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Ventilatory equivalent, rate of ventilation and absolute CO2 (VE/CO2) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
(1) Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): Speed (km/h) in First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
(1) Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): time in sencond (s) when it appears First Ventilatory Threshold, Second Ventilatory Threshold and at maximum test time.
Time frame: From enrollment to the end of treatment at 32 weeks
Physical fitness
(1) Cardiorespiratory fitness assessed via a performance test with gas analysis using ergometry (incremental test to exhaustion): V-Slope break-point (%)
Time frame: From enrollment to the end of treatment at 32 weeks
Metabolic profile
Clinical and biochemical variables will be included to identify metabolic alterations associated with the risk of developing Type 2 Diabetes Mellitus (T2DM) and cardiovascular diseases (CVD), based on the criteria proposed by the International Diabetes Federation (IDF): Biochemical variables (fasting): glucose (mg/dL)
Time frame: From enrollment to the end of treatment at 32 weeks
Metabolic profile
Clinical and biochemical variables will be included to identify metabolic alterations associated with the risk of developing Type 2 Diabetes Mellitus (T2DM) and cardiovascular diseases (CVD), based on the criteria proposed by the International Diabetes Federation (IDF): Biochemical variables (fasting): triglycerides (mg/dL)
Time frame: From enrollment to the end of treatment at 32 weeks
Metabolic profile
Clinical and biochemical variables will be included to identify metabolic alterations associated with the risk of developing Type 2 Diabetes Mellitus (T2DM) and cardiovascular diseases (CVD), based on the criteria proposed by the International Diabetes Federation (IDF): Biochemical variables (fasting): total cholesterol (mg/dL)
Time frame: From enrollment to the end of treatment at 32 weeks
Metabolic profile
Clinical and biochemical variables will be included to identify metabolic alterations associated with the risk of developing Type 2 Diabetes Mellitus (T2DM) and cardiovascular diseases (CVD), based on the criteria proposed by the International Diabetes Federation (IDF): Biochemical variables (fasting): HDL-cholesterol (mg/dL)
Time frame: From enrollment to the end of treatment at 32 weeks
Metabolic profile
Clinical and biochemical variables will be included to identify metabolic alterations associated with the risk of developing Type 2 Diabetes Mellitus (T2DM) and cardiovascular diseases (CVD), based on the criteria proposed by the International Diabetes Federation (IDF): Clinical variables: blood pressure (mmHg)
Time frame: From enrollment to the end of treatment at 32 weeks
Metabolic profile
Clinical and biochemical variables will be included to identify metabolic alterations associated with the risk of developing Type 2 Diabetes Mellitus (T2DM) and cardiovascular diseases (CVD), based on the criteria proposed by the International Diabetes Federation (IDF): Clinical variables: waist circumference (cm)
Time frame: From enrollment to the end of treatment at 32 weeks
Oxidative status
The following markers will be analyzed using spectrophotometry: malondialdehyde, MDA (µmol/L) (absorbance at 532 nm)
Time frame: From enrollment to the end of treatment at 32 weeks
Oxidative status
The following markers will be analyzed using spectrophotometry: glutathione peroxidase, GPX (U/mL) (absorbance at 340 nm)
Time frame: From enrollment to the end of treatment at 32 weeks
Oxidative status
The following markers will be analyzed using spectrophotometry: total antioxidant capacity, TAC (µmol TE/L) (fluoresence).
Time frame: From enrollment to the end of treatment at 32 weeks
Anabolic and functional profile
Enzyme-linked immunosorbent assay (ELISA) techniques using validated commercial kits for serum/plasma will be used to analyze: insulin-like growth factor 1, IGF-1 (ng/mL)
Time frame: From enrollment to the end of treatment at 32 weeks
Anabolic and functional profile
Enzyme-linked immunosorbent assay (ELISA) techniques using validated commercial kits for serum/plasma will be used to analyze: Myostatin (ng/mL)
Time frame: From enrollment to the end of treatment at 32 weeks
Anabolic and functional profile
Enzyme-linked immunosorbent assay (ELISA) techniques using validated commercial kits for serum/plasma will be used to analyze: Testosterone (ng/mL)
Time frame: From enrollment to the end of treatment at 32 weeks
Anabolic and functional profile
Enzyme-linked immunosorbent assay (ELISA) techniques using validated commercial kits for serum/plasma will be used to analyze: Vitamin D (ng/mL).
Time frame: From enrollment to the end of treatment at 32 weeks
Inflammation markers
Enzyme-linked immunosorbent assay (ELISA) techniques using validated commercial kits for serum/plasma will be used to analyze: α-Klotho (pg/mL)
Time frame: From enrollment to the end of treatment at 32 weeks
Inflammation markers
Enzyme-linked immunosorbent assay (ELISA) techniques using validated commercial kits for serum/plasma will be used to analyze: high-sensitivity C-reactive protein, hs-CRP (mg/L).
Time frame: From enrollment to the end of treatment at 32 weeks
Quality of life
These will be evaluated using the following questionnaires: SF-12 Health Survey version 2
Time frame: From enrollment to the end of treatment at 32 weeks
Cognitive function
These will be evaluated using the following questionnaires: Montreal Cognitive Assessment, (MoCA)
Time frame: From enrollment to the end of treatment at 32 weeks
Heart rate variability (HRV)
It will be evaluated through continuous heart rate monitoring during training sessions using the H10 POLAR system. Registred in ELITE HRV movil aplication and subsequently, the signals will be analyzed using KUBIOS HRV software to obtain the main heart rate variability (HRV) indicators as a reflection of autonomic modulation. The parameters considered will be: heart rate, HR (bpm)
Time frame: From enrollment to the end of treatment at 32 weeks
Heart rate variability (HRV)
It will be evaluated through continuous heart rate monitoring during training sessions using the H10 POLAR system. Registred in ELITE HRV movil aplication and subsequently, the signals will be analyzed using KUBIOS HRV software to obtain the main heart rate variability (HRV) indicators as a reflection of autonomic modulation. The parameters considered will be: standard deviation of NN intervals, SDNN (ms)
Time frame: From enrollment to the end of treatment at 32 weeks
Heart rate variability (HRV)
It will be evaluated through continuous heart rate monitoring during training sessions using the H10 POLAR system. Registred in ELITE HRV movil aplication and subsequently, the signals will be analyzed using KUBIOS HRV software to obtain the main heart rate variability (HRV) indicators as a reflection of autonomic modulation. The parameters considered will be: root mean square of successive differences between NN intervals, RMSSD (ms)
Time frame: From enrollment to the end of treatment at 32 weeks
Heart rate variability (HRV)
It will be evaluated through continuous heart rate monitoring during training sessions using the H10 POLAR system. Registred in ELITE HRV movil aplication and subsequently, the signals will be analyzed using KUBIOS HRV software to obtain the main heart rate variability (HRV) indicators as a reflection of autonomic modulation. The parameters considered will be: percentage of NN intervals that differ by more than 50 ms, pNN50 (%)
Time frame: From enrollment to the end of treatment at 32 weeks
Heart rate variability (HRV)
It will be evaluated through continuous heart rate monitoring during training sessions using the H10 POLAR system. Registred in ELITE HRV movil aplication and subsequently, the signals will be analyzed using KUBIOS HRV software to obtain the main heart rate variability (HRV) indicators as a reflection of autonomic modulation. The parameters considered will be: low frequency, LF (ms²)
Time frame: From enrollment to the end of treatment at 32 weeks
Heart rate variability (HRV)
It will be evaluated through continuous heart rate monitoring during training sessions using the H10 POLAR system. Registred in ELITE HRV movil aplication and subsequently, the signals will be analyzed using KUBIOS HRV software to obtain the main heart rate variability (HRV) indicators as a reflection of autonomic modulation. The parameters considered will be: high frequency, HF (ms²)
Time frame: From enrollment to the end of treatment at 32 weeks
Heart rate variability (HRV)
It will be evaluated through continuous heart rate monitoring during training sessions using the H10 POLAR system. Registred in ELITE HRV movil aplication and subsequently, the signals will be analyzed using KUBIOS HRV software to obtain the main heart rate variability (HRV) indicators as a reflection of autonomic modulation. The parameters considered will be: Low Frequency/ High Frequency Ratio(LF/HF ratio).
Time frame: From enrollment to the end of treatment at 32 weeks
Internal training load
It will be evaluated through continuous heart rate monitoring during training sessions using the POLAR Team system. Considering the following parameters: Average and Maximum Heart Rate (Avg HR / Max HR): This indicates the average effort and peak intensity
Time frame: From enrollment to the end of treatment at 32 weeks
Internal training load
It will be evaluated through continuous heart rate monitoring during training sessions using the POLAR Team system. Considering the following parameters: Time in Heart Rate Zones (Zones 1 to 5, defined by Martti Karvonen, Eric Banister and Stephen Seiler)
Time frame: From enrollment to the end of treatment at 32 weeks
Internal training load
It will be evaluated through continuous heart rate monitoring during training sessions using the POLAR Team system. Considering the following parameters: Cardio Load (Cardio Load / TRIMP): This is a numerical value calculated by Polar Team that combines intensity (HR) and session duration.
Time frame: From enrollment to the end of treatment at 32 weeks
External training load
The actual mechanical load will be quantified through triaxial accelerometry during training sessions, using accelerometers integrated into monitoring devices (Polar TEAM System) to record: Total Distance Covered: The total volume of the session (in meters or kilometers)
Time frame: From enrollment to the end of treatment at 32 weeks
External training load
The actual mechanical load will be quantified through triaxial accelerometry during training sessions, using accelerometers integrated into monitoring devices (Polar TEAM System) to record: Accelerations and Decelerations (Count, (m/s²)
Time frame: From enrollment to the end of treatment at 32 weeks
External training load
The actual mechanical load will be quantified through triaxial accelerometry during training sessions, using accelerometers integrated into monitoring devices (Polar TEAM System) to record: Muscle Load. Polar calculates this using accelerometer data (in watts or joules)
Time frame: From enrollment to the end of treatment at 32 weeks
External training load
The actual mechanical load will be quantified through triaxial accelerometry during training sessions, using accelerometers integrated into monitoring devices (Polar TEAM System) to record: Speed Zones (Time/Distance in Zones 1 and 2 in Km/h o m/h)
Time frame: From enrollment to the end of treatment at 32 weeks
External training load
The actual mechanical load will be quantified through triaxial accelerometry during training sessions, using accelerometers integrated into monitoring devices (Polar TEAM System) to record: Average and Maximum Speed in Km/h o m/h)
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (maximum)
Measured through isometric contraction: Upper limb, handgrip dynamometry, using a dial dynamometer to record the maximal handgrip strength in kilograms.
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (maximum)
Measured through isometric contraction: lower limb, Hawkin Strength platform using an Isometric Test (Half Squat with a strength specific belt). Variables to extract from this test: Absolute Maximal Strength (Peak Force - N): The highest strength recorded during the pull
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (maximum)
Measured through isometric contraction: lower limb, Hawkin Strength platform using an Isometric Test (Half Squat with a strength specific belt). Variables to extract from this test: Relative Maximal Strength (Peak Force Relative - N/kg)
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (maximum)
Measured through isometric contraction: lower limb, Hawkin Strength platform using an Isometric Test (Half Squat with a strength specific belt). Variables to extract from this test: Rate of Force Development in specific time windows (RFD between 0-100 ms and 0-200 ms - N/s): Measures static "explosive strength"
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (maximum)
Measured through isometric contraction: lower limb, Hawkin Strength platform using an Isometric Test (Half Squat with a strength specific belt). Variables to extract from this test: Maximal Strength Asymmetry (%): Indicates whether one lower limb exerts significantly more strength than the other.
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (Power and explosive strength)
Measured through isometric contraction: lower limb, Hawkin Strength platform using a Counter Movement Jump test (CMJ). Variables to extract from this test: Absolute Peak Power (W) and Relative Peak Power (W/kg)
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (Power and explosive strength)
Measured through isometric contraction: lower limb, Hawkin Strength platform using a Counter Movement Jump test (CMJ). Variables to extract from this test: Jump Height (m or cm)
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (Power and explosive strength)
Measured through isometric contraction: lower limb, Hawkin Strength platform using a Counter Movement Jump test (CMJ). Variables to extract from this test: Modified Reactive Strength Index (mRSI or RSImod - AU): Calculated by dividing the jump height by the total time to takeoff.
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (Power and explosive strength)
Measured through isometric contraction: lower limb, Hawkin Strength platform using a Counter Movement Jump test (CMJ). Variables to extract from this test: Propulsion Mean strangth (N or N/kg): The average strength applied to push off the ground
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (Power and explosive strength)
Measured through isometric contraction: lower limb, Hawkin Strength platform using a Counter Movement Jump test (CMJ). Variables to extract from this test: Active Braking / Deceleration Strength (Braking Phase Metrics): Extract the Braking Peak strength
Time frame: From enrollment to the end of treatment at 32 weeks
Muscular strength (Power and explosive strength)
Measured through isometric contraction: lower limb, Hawkin Strength platform using a Counter Movement Jump test (CMJ). Variables to extract from this test: • Asymmetry in the Propulsion and Braking Phase (%): Hawkin Dynamics breaks down the imbalances between the left and right leg during each phase of the dynamic movement.
Time frame: From enrollment to the end of treatment at 32 weeks
Dynamic Strength Index (DSI)
relationship between explosive (dynamic) strength and theoretical maximal (isometric) strength. It tells us what percentage of their maximal strength the subject is capable of applying quickly. This variable is derived from Relative Maximal Strength (N/kg) isometric test / Relative Maximal Power (W/kg) from CMJ test.
Time frame: From enrollment to the end of treatment at 32 weeks
Characterization variables (collected through interview and individual history)
Sociodemographic: age, sex, educational level, employment status, marital status, and years since retirement.
Time frame: At enrollment time
Characterization variables (collected through interview and individual history)
Clinical: Medical history, comorbidities, time since diagnosis, current medication, tobacco habits (status, daily cigarettes, active years, and pack-years), and alcohol intake (status, weekly frequency, and SDUs/week).
Time frame: At enrollment time
Characterization variables (collected through interview and individual history)
Sports-related: years of walking football practice, training frequency, sports injuries, athletic history, and physical activity level based on the criteria of the American College of Sports Medicine (ACSM) cardiovascular risk questionnaire.
Time frame: At enrollment time
No study locations are listed for this record.
Plan to share: No
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Universidad Europea de Madrid