Clinical trial NCT05849350: Protein Supplementation in Pilates Training
Official title: Effects of Pilates Training and Protein Supplementation on Body Composition, Performance, and Biochemical Indices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Training
Dietary Supplements
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Lean mass and fat mass pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Lean mass and fat mass post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Bone mineral density pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Bone mineral density post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Bone mineral content pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Bone mineral content post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Bone area pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Bone area post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Body fat % and lean % pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Body fat % and lean % post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Body weight pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Body weight post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Waist and hip circumferences pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Waist and hip circumferences post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Joint flexibility pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Joint flexibility post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Core muscle endurance pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Core muscle endurance post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Plasma glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Plasma amino acid profile pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Plasma amino acid profile post-supplementation
timeFrame: Within one week after the end of supplementation.
Secondary outcomes:
measure: Full blood count pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Full blood count post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Plasma enzymes pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Plasma enzymes post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Cortisol pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Cortisol post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Progesterone and testosterone pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Progesterone and testosterone post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Estradiol pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Estradiol post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Plasma urea and creatinine pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Plasma urea and creatinine post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Total body water %, intracellular water %, and extracellular water % pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Total body water %, intracellular water %, and extracellular water % post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Total body water, intracellular water, and extracellular water pre-supplementation
timeFrame: Within one week before the beginning of supplementation.
measure: Total body water, intracellular water, and extracellular water post-supplementation
timeFrame: Within one week after the end of supplementation.
measure: Body mass index (BMI) pre-supplementation
timeFrame: Within one week before the beginning of supplementation
measure: Body mass index (BMI) post-supplementation
timeFrame: Within one week after the end of supplementation.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Evaluation of Human Biological Performance
Study officials:
References: