Protein Supplementation in Pilates Training

• ClinicalTrials.gov Identifier: NCT05849350
• Recruitment Status: Completed
• First Posted: May 8, 2023
• Last Update Posted: March 22, 2024
• Sponsor: Aristotle University Of Thessaloniki
• Information provided by (Responsible Party): Aristotle University Of Thessaloniki

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Exercise Training; Dietary Supplements	Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Effects of Pilates Training and Protein Supplementation on Body Composition, Performance, and Biochemical Indices
• Actual Study Start Date: January 20, 2023
• Actual Primary Completion Date: April 9, 2023
• Actual Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Protein; Participants will receive a whey protein supplement.	Dietary Supplement: Whey protein; Intake of whey protein
Placebo Comparator: Maltodextrin; Participants will receive an isocaloric maltodextrin supplement.	Dietary Supplement: Maltodextrin; Intake of maltodextrin

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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
12. 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
13. 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
14. 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
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.

Secondary Outcome Measures :

1. Full blood count pre-supplementation [ Time Frame: Within one week before the beginning of supplementation. ]
   Full blood count will be performed by flow cytometry
2. Full blood count post-supplementation [ Time Frame: Within one week after the end of supplementation. ]
   Full blood count will be performed by flow cytometry
3. 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
4. Plasma enzymes post-supplementation [ Time Frame: Within one week after the end of supplementation. ]
   Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer
5. Cortisol pre-supplementation [ Time Frame: Within one week before the beginning of supplementation. ]
   Plasma Cortisol (μg/dL) will be measured by immunoluminescence in an automated analyzer.
6. Cortisol post-supplementation [ Time Frame: Within one week after the end of supplementation. ]
   Plasma Cortisol (μg/dL) will be measured by immunoluminescence in an automated analyzer.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. Plasma urea and creatinine post-supplementation [ Time Frame: Within one week after the end of supplementation. ]
    Plasma urea and creatinine (both in mg/dL) will be measured by chemiluminescence in an automated analyzer.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Greece

Laboratory of Evaluation of Human Biological Performance

Thessaloniki, Greece, 57001

Sponsors and Collaborators

Aristotle University Of Thessaloniki

More Information

• Responsible Party: Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT05849350
• Other Study ID Numbers: PilatesProtein1
• First Posted: May 8, 2023
• Last Update Posted: March 22, 2024
• Last Verified: March 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No