- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05849350
Protein Supplementation in Pilates Training
Effects of Pilates Training and Protein Supplementation on Body Composition, Performance, and Biochemical Indices
Pilates training, a type of mind and body exercise that focuses on muscle strength and flexibility, has become increasingly popular in recent years. Research has shown that Pilates could be an effective exercise form to improve body composition, particularly in obese individuals, while beneficial effects on flexibility, muscular strength, and muscular endurance have also been observed in young and older adults. It is well documented that protein supplementation can augment the effects of resistance training on body composition and performance. While there is an abundance of studies investigating the effect of protein supplements on adaptations to resistance exercise, there is a knowledge gap regarding their effectiveness in Pilates training.
The aim of this research is to investigate the effects of protein supplementation, compared to placebo (maltodextrin) on body composition, performance, and biochemical indices in healthy young and middle-aged, eumenorrheic (regular menstrual cycle) women who perform Pilates. Participants will be randomly assigned to receive either 0.6 g of whey protein or maltodextrin per kg body weight per day for 10 weeks. Participants will be asked to avoid modifying their dietary habits for the duration of the study to limit the effect of diet on the measured parameters. To check for this, participants will record their diet for 3 days (2 weekdays and one weekend day) on the first, middle, and last weeks of the intervention. Dietary records will then be analyzed. Pilates classes will be performed at least two times per week, while specialized Pilates equipment (Reformer or Cadillac) will be used according to the Pilates principles. The duration of each workout will be set at around 50 min.
Participants will undergo measurements of body composition, core muscle endurance, and joint flexibility at the beginning and end of the study. In addition, hematologic parameters, clinical chemistry parameters, hormones, and plasma amino acids will be measured. All these outcome measures will be compared between the whey protein and maltodextrin groups to determine the effectiveness of protein supplementation in Pilates training.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Thessaloniki, Greece, 57001
- Laboratory of Evaluation of Human Biological Performance
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eumenorrheic (regular menstrual cycle) women
- Regular Pilates training (at least 2 times a week, 50 min each session, for the past 4 months), as assessed by gym records or questionnaires
- Mixed isoenergetic diet for the past 4 months
Exclusion Criteria:
- Any musculoskeletal injuries that could interfere with training
- Chronic disease
- Milk allergy
- Pregnancy, lactation, or planning a pregnancy within the duration of the study
- Regular use of prescription medicine or supplements that might affect muscle function or recovery over the past month
- Intermittent or religious fasting
- Any vegetarian, ketogenic or protein diet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Protein
Participants will receive a whey protein supplement.
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Intake of whey protein
|
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Placebo Comparator: Maltodextrin
Participants will receive an isocaloric maltodextrin supplement.
|
Intake of maltodextrin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone mineral density pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Bone mineral density of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
|
Within one week before the beginning of supplementation.
|
|
Bone mineral density post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Bone mineral density of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
|
Within one week after the end of supplementation.
|
|
Body fat % and lean % pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Body fat as a % of total body weight will be assessed by dual X-ray absorptiometry and multifrequency bioelectrical impedance analysis.
Lean as a % of total body weight will be assessed by multifrequency bioelectrical impedance analysis.
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Within one week before the beginning of supplementation.
|
|
Body fat % and lean % post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Body fat as a % of total body weight will be assessed by dual X-ray absorptiometry and multifrequency bioelectrical impedance analysis.
Lean as a % of total body weight will be assessed by multifrequency bioelectrical impedance analysis.
|
Within one week after the end of supplementation.
|
|
Body weight pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Body weight will be measured with an electronic scale to the nearest 0.1 kg
|
Within one week before the beginning of supplementation.
|
|
Body weight post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Body weight will be measured with an electronic scale to the nearest 0.1 kg
|
Within one week after the end of supplementation.
|
|
Waist and hip circumferences pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Waist and hip circumferences will be measured with a non-extendable tape
|
Within one week before the beginning of supplementation.
|
|
Waist and hip circumferences post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Waist and hip circumferences will be measured with a non-extendable tape
|
Within one week after the end of supplementation.
|
|
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.
|
Within one week before the beginning of supplementation.
|
|
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.
|
Within one week after the end of supplementation.
|
|
Plasma amino acid profile pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography-mass spectrometry.
|
Within one week before the beginning of supplementation.
|
|
Plasma amino acid profile post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography-mass spectrometry.
|
Within one week after the end of supplementation.
|
|
Lean mass and fat mass pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Lean mass and fat mass of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Whole body lean, dry lean and fat mass will also be assessed by multifrequency bioelectrical impedance analysis.
|
Within one week before the beginning of supplementation.
|
|
Lean mass and fat mass post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Lean mass and fat mass of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
Whole body lean, dry lean and fat mass will also be assessed by multifrequency bioelectrical impedance analysis.
|
Within one week after the end of supplementation.
|
|
Bone mineral content pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Bone mineral content of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
|
Within one week before the beginning of supplementation.
|
|
Bone mineral content post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Bone mineral content of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
|
Within one week after the end of supplementation.
|
|
Bone area pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Bone area of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
|
Within one week before the beginning of supplementation.
|
|
Bone area post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Bone area of the whole body and its parts (arms, legs, trunk) will be assessed by dual X-ray absorptiometry.
|
Within one week after the end of supplementation.
|
|
Joint flexibility pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Joint flexibility will be assessed through the sit and reach test.
|
Within one week before the beginning of supplementation.
|
|
Joint flexibility post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Joint flexibility will be assessed through the sit and reach test.
|
Within one week after the end of supplementation.
|
|
Core muscle endurance pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Core muscle endurance (trunk flexor, trunk lateral right, trunk lateral left, and trunk extensors) will be assessed through the McGill's torso muscular endurance test battery.
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Within one week before the beginning of supplementation.
|
|
Core muscle endurance post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Core muscle endurance (trunk flexor, trunk lateral right, trunk lateral left, and trunk extensors) will be assessed through the McGill's torso muscular endurance test battery.
|
Within one week after the end of supplementation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Full blood count pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Full blood count will be performed by flow cytometry
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Within one week before the beginning of supplementation.
|
|
Full blood count post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Full blood count will be performed by flow cytometry
|
Within one week after the end of supplementation.
|
|
Plasma enzymes pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer
|
Within one week before the beginning of supplementation.
|
|
Plasma enzymes post-supplementation
Time Frame: Within one week after the end of supplementation.
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Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer
|
Within one week after the end of supplementation.
|
|
Cortisol pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
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Plasma Cortisol (μg/dL) will be measured by immunoluminescence in an automated analyzer.
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Within one week before the beginning of supplementation.
|
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Cortisol post-supplementation
Time Frame: Within one week after the end of supplementation.
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Plasma Cortisol (μg/dL) will be measured by immunoluminescence in an automated analyzer.
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Within one week after the end of supplementation.
|
|
Progesterone and testosterone pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Plasma progesterone and testosterone (both in ng/dL) will be measured by immunoluminescence in an automated analyzer.
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Within one week before the beginning of supplementation.
|
|
Progesterone and testosterone post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Plasma progesterone and testosterone (both in ng/dL) will be measured by immunoluminescence in an automated analyzer.
|
Within one week after the end of supplementation.
|
|
Estradiol pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Plasma estradiol (pg/mL) will be measured by immunoluminescence in an automated analyzer.
|
Within one week before the beginning of supplementation.
|
|
Estradiol post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Plasma estradiol (pg/mL) will be measured by immunoluminescence in an automated analyzer.
|
Within one week after the end of supplementation.
|
|
Plasma urea and creatinine pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Plasma urea and creatinine (both in mg/dL) will be measured by chemiluminescence in an automated analyzer.
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Within one week before the beginning of supplementation.
|
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Plasma urea and creatinine post-supplementation
Time Frame: Within one week after the end of supplementation.
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Plasma urea and creatinine (both in mg/dL) will be measured by chemiluminescence in an automated analyzer.
|
Within one week after the end of supplementation.
|
|
Total body water %, intracellular water %, and extracellular water % pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Total body water, intracellular water, and extracellular water (all as % of total body weight) will be assessed by multifrequency bioelectrical impedance analysis.
|
Within one week before the beginning of supplementation.
|
|
Total body water %, intracellular water %, and extracellular water % post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Total body water, intracellular water, and extracellular water (all as % of total body weight) will be assessed by multifrequency bioelectrical impedance analysis.
|
Within one week after the end of supplementation.
|
|
Total body water, intracellular water, and extracellular water pre-supplementation
Time Frame: Within one week before the beginning of supplementation.
|
Total body water, intracellular water, and extracellular water (all in Lt) will be assessed by multifrequency bioelectrical impedance analysis.
|
Within one week before the beginning of supplementation.
|
|
Total body water, intracellular water, and extracellular water post-supplementation
Time Frame: Within one week after the end of supplementation.
|
Total body water, intracellular water, and extracellular water (all in Lt) will be assessed by multifrequency bioelectrical impedance analysis.
|
Within one week after the end of supplementation.
|
|
Body mass index (BMI) pre-supplementation
Time Frame: Within one week before the beginning of supplementation
|
BMI will be calculated by divinding weight by height squared.
|
Within one week before the beginning of supplementation
|
|
Body mass index (BMI) post-supplementation
Time Frame: Within one week after the end of supplementation.
|
BMI will be calculated by divinding weight by height squared.
|
Within one week after the end of supplementation.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PilatesProtein1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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