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临床试验/NCT05849350
NCT05849350已完成不适用

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

Aristotle University Of Thessaloniki2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Bone mineral density post-supplementation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Bone mineral density post-supplementation

时间窗: 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.

Lean mass and fat mass post-supplementation

时间窗: 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.

Bone mineral density pre-supplementation

时间窗: 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.

Bone area pre-supplementation

时间窗: 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.

Body fat % and lean % pre-supplementation

时间窗: 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.

Body weight post-supplementation

时间窗: Within one week after the end of supplementation.

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

Joint flexibility pre-supplementation

时间窗: Within one week before the beginning of supplementation.

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

Lean mass and fat mass pre-supplementation

时间窗: 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.

Waist and hip circumferences post-supplementation

时间窗: Within one week after the end of supplementation.

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

Core muscle endurance pre-supplementation

时间窗: 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.

Core muscle endurance post-supplementation

时间窗: 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.

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

时间窗: 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.

Plasma amino acid profile pre-supplementation

时间窗: 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.

Bone mineral content pre-supplementation

时间窗: 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.

Bone area post-supplementation

时间窗: 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.

Body weight pre-supplementation

时间窗: Within one week before the beginning of supplementation.

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

Plasma amino acid profile post-supplementation

时间窗: 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.

Bone mineral content post-supplementation

时间窗: 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.

Body fat % and lean % post-supplementation

时间窗: 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.

Joint flexibility post-supplementation

时间窗: Within one week after the end of supplementation.

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

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

时间窗: 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.

Waist and hip circumferences pre-supplementation

时间窗: Within one week before the beginning of supplementation.

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

次要结局

  • Full blood count post-supplementation(Within one week after the end of supplementation.)
  • Plasma urea and creatinine pre-supplementation(Within one week before the beginning of supplementation.)
  • 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 post-supplementation(Within one week after the end of supplementation.)
  • Plasma enzymes pre-supplementation(Within one week before the beginning of supplementation.)
  • Body mass index (BMI) post-supplementation(Within one week after the end of supplementation.)
  • Full blood count pre-supplementation(Within one week before the beginning of supplementation.)
  • Plasma enzymes post-supplementation(Within one week after the end of supplementation.)
  • Estradiol post-supplementation(Within one week after the end of supplementation.)
  • Total body water, intracellular water, and extracellular water pre-supplementation(Within one week before the beginning of supplementation.)
  • Cortisol post-supplementation(Within one week after the end of supplementation.)
  • Progesterone and testosterone pre-supplementation(Within one week before the beginning of supplementation.)
  • Estradiol pre-supplementation(Within one week before the beginning of supplementation.)
  • Plasma urea and creatinine post-supplementation(Within one week after the end of supplementation.)
  • Cortisol pre-supplementation(Within one week before the beginning of supplementation.)
  • Progesterone and testosterone post-supplementation(Within one week after the end of supplementation.)
  • Total body water %, intracellular water %, and extracellular water % post-supplementation(Within one week after the end of supplementation.)
  • Body mass index (BMI) pre-supplementation(Within one week before the beginning of supplementation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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