Protein Supplementation in Pilates Training

Study Overview
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Brief Summary
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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 and performance 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, strength endurance of core muscles, and 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.

Official Title
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Effects of Pilates Training and Protein Supplementation on Body Composition, Performance, and Biochemical Indices

Conditions
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Exercise Training, Dietary Supplements

Intervention / Treatment
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* Dietary Supplement: Whey protein
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eumenorrheic (regular menstrual cycle) women Normal body fat (8-30 %) 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: Smoking (even one cigarette or nicotine-containing device over the past 6 months) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protein<br>Participants will receive a whey protein supplement. | Dietary Supplement: Whey protein<br>* Intake of whey protein<br>|
| Placebo Comparator: Maltodextrin<br>Participants will receive an isocaloric maltodextrin supplement that looks identical to the whey protein supplement. | Dietary Supplement: Maltodextrin<br>* Intake of maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean and dry lean mass, fat mass, and bone mass pre-supplementation | Lean mass, fat mass, and bone 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 and dry lean mass, fat mass, and bone mass pre-supplementation | Lean mass, fat mass, and bone 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 density pre-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 | 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 | 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 before the beginning of supplementation. | 
| Body fat % and lean % post-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 | 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 | 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 | 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 | Waist and hip circumferences will be measured with a non-extendable tape | Within one week after the end of supplementation. | 
| Flexibility pre-supplementation | Flexibility will be assessed through the sit and reach test. | Within one week before the beginning of supplementation. | 
| Flexibility post-supplementation | Flexibility will be assessed through the sit and reach test. | Within one week after the end of supplementation. | 
| Strength endurance of core muscles pre-supplementation | Strength endurance of core muscles (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 before the beginning of supplementation. | 
| Strength endurance of core muscles post-supplementation | Strength endurance of core muscles (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. | 
| Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols pre-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 | 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 | 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 | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full blood count pre-supplementation | Full blood count will be performed by flow cytometry | Within one week before the beginning of supplementation. | 
| Full blood count post-supplementation | Full blood count will be performed by flow cytometry | Within one week after the end of supplementation. | 
| Plasma enzymes pre-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 | 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 | Plasma Cortisol (μg/dL) will be measured by immunoluminescence in an automated analyzer. | Within one week before the beginning of supplementation. | 
| Cortisol post-supplementation | Plasma Cortisol (μg/dL) will be measured by immunoluminescence in an automated analyzer. | Within one week after the end of supplementation. | 
| Progesterone and testosterone pre-supplementation | Plasma progesterone and testosterone (both in ng/dL) will be measured by immunoluminescence in an automated analyzer. | Within one week before the beginning of supplementation. | 
| Progesterone and testosterone post-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 | Plasma estradiol (pg/mL) will be measured by immunoluminescence in an automated analyzer. | Within one week before the beginning of supplementation. | 
| Estradiol post-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 | Plasma urea and creatinine (both in mg/dL) will be measured by chemiluminescence in an automated analyzer. | Within one week before the beginning of supplementation. | 
| Plasma urea and creatinine post-supplementation | 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 | 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 | 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 | 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 | 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. |