Protein Supplementation in Pilates Training

Exercise Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05849350
• Other study ID #: PilatesProtein1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: March 2024
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2023
• Est. primary completion date: April 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Supplements
• Exercise Training

Intervention

Dietary Supplement:
• Whey protein
Intake of whey protein
• Maltodextrin
Intake of maltodextrin

Locations

Country	Name	City	State
Greece	Laboratory of Evaluation of Human Biological Performance	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lean mass and fat mass pre-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.
Primary	Lean mass and fat mass post-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.
Primary	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.
Primary	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.
Primary	Bone mineral content pre-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.
Primary	Bone mineral content post-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.
Primary	Bone area pre-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.
Primary	Bone area post-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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Joint flexibility pre-supplementation	Joint flexibility will be assessed through the sit and reach test.	Within one week before the beginning of supplementation.
Primary	Joint flexibility post-supplementation	Joint flexibility will be assessed through the sit and reach test.	Within one week after the end of supplementation.
Primary	Core muscle endurance pre-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 before the beginning of supplementation.
Primary	Core muscle endurance post-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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Full blood count pre-supplementation	Full blood count will be performed by flow cytometry	Within one week before the beginning of supplementation.
Secondary	Full blood count post-supplementation	Full blood count will be performed by flow cytometry	Within one week after the end of supplementation.
Secondary	Plasma enzymes pre-supplementation	Creatine kinase and ?-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer	Within one week before the beginning of supplementation.
Secondary	Plasma enzymes post-supplementation	Creatine kinase and ?-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer	Within one week after the end of supplementation.
Secondary	Cortisol pre-supplementation	Plasma Cortisol (µg/dL) will be measured by immunoluminescence in an automated analyzer.	Within one week before the beginning of supplementation.
Secondary	Cortisol post-supplementation	Plasma Cortisol (µg/dL) will be measured by immunoluminescence in an automated analyzer.	Within one week after the end of supplementation.
Secondary	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.
Secondary	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.
Secondary	Estradiol pre-supplementation	Plasma estradiol (pg/mL) will be measured by immunoluminescence in an automated analyzer.	Within one week before the beginning of supplementation.
Secondary	Estradiol post-supplementation	Plasma estradiol (pg/mL) will be measured by immunoluminescence in an automated analyzer.	Within one week after the end of supplementation.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Body mass index (BMI) pre-supplementation	BMI will be calculated by divinding weight by height squared.	Within one week before the beginning of supplementation
Secondary	Body mass index (BMI) post-supplementation	BMI will be calculated by divinding weight by height squared.	Within one week after the end of supplementation.