Protein Supplementation in Pilates Training

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05849350
Collaborator
(none)
19
1
2
4.3
4.4

Study Details

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 and performance in healthy young and middle-aged, eumenorroic (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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Whey protein
  • Dietary Supplement: Maltodextrin
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
19 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 :
Jan 20, 2023
Actual Primary Completion Date :
Apr 9, 2023
Anticipated 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 that looks identical to the whey protein supplement.

Dietary Supplement: Maltodextrin
Intake of maltodextrin

Outcome Measures

Primary Outcome Measures

  1. Lean and dry lean mass, fat mass, and bone mass pre-supplementation [Within one week before the beginning of 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.

  2. Lean and dry lean mass, fat mass, and bone mass pre-supplementation [Within one week after the end of 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.

  3. Bone mineral density pre-supplementation [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 [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. Body fat % and lean % pre-supplementation [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.

  6. Body fat % and lean % post-supplementation [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.

  7. Body weight pre-supplementation [Within one week before the beginning of supplementation.]

    Body weight will be measured with an electronic scale to the nearest 0.1 kg

  8. Body weight post-supplementation [Within one week after the end of supplementation.]

    Body weight will be measured with an electronic scale to the nearest 0.1 kg

  9. Waist and hip circumferences pre-supplementation [Within one week before the beginning of supplementation.]

    Waist and hip circumferences will be measured with a non-extendable tape

  10. Waist and hip circumferences post-supplementation [Within one week after the end of supplementation.]

    Waist and hip circumferences will be measured with a non-extendable tape

  11. Flexibility pre-supplementation [Within one week before the beginning of supplementation.]

    Flexibility will be assessed through the sit and reach test.

  12. Flexibility post-supplementation [Within one week after the end of supplementation.]

    Flexibility will be assessed through the sit and reach test.

  13. Strength endurance of core muscles pre-supplementation [Within one week before the beginning of 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.

  14. Strength endurance of core muscles post-supplementation [Within one week after the end of 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.

  15. Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols pre-supplementation [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.

  16. Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols post-supplementation [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.

  17. Plasma amino acid profile pre-supplementation [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.

  18. Plasma amino acid profile post-supplementation [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 [Within one week before the beginning of supplementation.]

    Full blood count will be performed by flow cytometry

  2. Full blood count post-supplementation [Within one week after the end of supplementation.]

    Full blood count will be performed by flow cytometry

  3. Plasma enzymes pre-supplementation [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Eumenorroic (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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laboratory of Evaluation of Human Biological Performance Thessaloniki Greece 57001

Sponsors and Collaborators

  • Aristotle University Of Thessaloniki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT05849350
Other Study ID Numbers:
  • PilatesProtein1
First Posted:
May 8, 2023
Last Update Posted:
May 8, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 8, 2023