Protein Supplementation in Pilates Training

NCT05849350 | Completed

• 1 other identifier: PilatesProtein1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Training; Dietary Supplements

Outcome Measures

Primary Outcomes (22)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Joint flexibility pre-supplementation

  Joint flexibility will be assessed through the sit and reach test.

  Within one week before the beginning of supplementation.

• Joint flexibility post-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

  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.

• 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.

• 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 Outcomes (18)

• Full blood count pre-supplementation

  Within one week before the beginning of supplementation.

• Full blood count post-supplementation

  Within one week after the end of supplementation.

• Plasma enzymes pre-supplementation

  Within one week before the beginning of supplementation.

• Plasma enzymes post-supplementation

  Within one week after the end of supplementation.

• Cortisol pre-supplementation

  Within one week before the beginning of supplementation.

Study Arms (2)

Protein

EXPERIMENTAL

Participants will receive a whey protein supplement.

Dietary Supplement: Whey protein

Maltodextrin

PLACEBO COMPARATOR

Participants will receive an isocaloric maltodextrin supplement.

Dietary Supplement: Maltodextrin

Interventions

Whey protein DIETARY_SUPPLEMENT

Intake of whey protein

Protein

Maltodextrin DIETARY_SUPPLEMENT

Intake of maltodextrin

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Laboratory of Evaluation of Human Biological Performance

Thessaloniki, 57001, Greece

Location

MeSH Terms

Interventions

Whey Proteins; maltodextrin

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 8, 2023
• Study Start: January 20, 2023
• Primary Completion: April 9, 2023
• Study Completion: May 31, 2023
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

GR (1)