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临床试验/NCT05228236
NCT05228236已完成不适用

Comparing the Effects of Plant Based Protein vs. Whey Protein on Performance and Body Composition of Futsal Players

Bettery S.A.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Performance parameter - change in peak power

研究概览

简要总结

This study aimed to investigate the effects of a newly developed plant-based protein blend regarding health and safety, body composition, and performance on healthy and physically active adult individuals, specifically team sports athletes. A randomized, double-blind, controlled trial was used to compare the effects of the plant-based protein versus whey protein, after an 8-week supplementation protocol, on body composition, biochemical markers, muscle strength and power, as well as aerobic performance in male futsal players. The working hypothesis is that this special blend of plant-based protein will be equivalent to whey protein, not only regarding body composition and performance, but also insofar as health and safety at the biochemical and physiological level.

详细描述

A randomized, double-blind, controlled trial was performed to investigate health and safety following supplementation with a newly developed plant-based protein blend and to compare the effects of this plant-based protein versus whey protein, after an 8-week supplementation protocol, on body composition and performance. Prior to intervention, volunteers' general health and ability to participate in the study were assessed. The study involved 50 male futsal players currently engaged in a training program and competing. Before engaging the 8-week supplementation protocol, participants underwent measurements of body composition, strength and power, and aerobic performance, as well as a full profile of biochemical health markers, and assessment of food and fluid intake. Evaluations were repeated after 4 weeks, for follow up and to detect potential compliance issues, and after 8 weeks of supplementation. Assessments took place in the morning (starting at 7:00 a.m.) after an overnight fast, except for the performance tests, which were performed following consumption of a standard, meal replacement bar.

Anthropometry and Body Composition - Wearing minimal clothing and no shoes, participants had their weight and height measured on a scale and stadiometer (Seca, Hamburg, Germany), respectively. Body composition, namely bone mineral content, fat mass and fat free mass, were evaluated by dual energy X-ray absorptiometry (DXA) (Horizon Wi, Hologic, Waltham, USA) and skeletal muscle through the evaluation of the muscle thickness of the rectus femoris by ultrasonography (model WED-180 HL, Shenzhen,China). Total body water and its intra and extracellular compartments were estimated from whole body resistance (R) and reactance (Xc), measured through bioelectrical impedance analysis (BIA), using a single frequency device of 50 kHz (BIA-101, RJL/Akern Systems, Firenze, Italy). From the raw R and Xc data, the phase angle was additionally determined, using the Akern Software.

Muscle Strength and Power, and Aerobic Performance - Strength was assessed using the handgrip strength test, as well as the back squat and bench press 1 repetition maximum (1 RM). The handgrip strength test was used to evaluate the maximal isometric force of the muscles of the hand and forearm. Using a portable hand dynamometer (JAMAR, Sammons Preston, Bolingbrook, IL, USA), participants were assessed for both hands alternately, in a stand-up position. The maximal force generated out of 3 attempts was considered for analysis. Additionally, muscle strength was evaluated by 1RM back squat and bench press in a Multipower machine, using a velocity-based training device (Vitruve Encoder, Madrid, Spain). Muscle power was assessed during maximal cycling (Wingate test) and jumping movements. During the Wingate test, participants were instructed to cycle (Monark 894 Peak Bike, Vansbro, Sweden) against a predetermined resistance (7.5% body weight), as fast as possible, for 30 seconds. Vertical jumps, namely the squat jump, countermovement jumps using both legs and single legs, as well as the Abalakov countermovement jump, were performed on a multicomponent force platform (Chronojump Boscosystem, Barcelona, Spain) interfaced with a computer. The best out of 3 attempts was also considered for analysis of this methodology. Aerobic performance was assessed by VO2peak and maximal aerobic speed (MAS), determined using a breath-by-breath gas analyzer (Quark, Cosmed, Italy) in an incremental test performed on a treadmill (Axelero, MEDEN-INMED, Koszalin, Poland). After 3 minutes of warm-up at 5 km/h, participants began the test at 6 km/h and 2% inclination. Each minute, the speed increased 1 km/h until volitional exhaustion. The VO2peak was considered the highest 30 sec average value of VO2 and MAS, the speed at the last completed stage.

All tasks were performed by the participants with direct supervision of sport scientists and/or exercise physiologists, with prior knowledge of the methodologies, and experience handling the equipments and corresponding softwares.

Biochemical Markers - For biochemical health markers, saliva and whole blood, in EDTA tubes, were collected per the standard protocols. . From whole blood, plasma was separated when necessary. Blood measurements included hematocrit, glucose, C-reactive protein (CRP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine kinase (CK), and creatinine, using spectrophotometry techniques in an automated equipment (Vario Photometer II DP310, Diglobal Gmbh, Berlin, Germany). Saliva was collected for cortisol evaluation in Enzyme-Linked Immunosorbent Assay (ELISA) commercial kits (Salimetrics, PA, USA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Subjects currently engaged in a Futsal training program in a competition team, currently engaged in practice for at least 1 year and at least 3 times per week.

排除标准

  • Individuals taking any type of drug (including anabolic steroids), medicines or supplements that may enhance body composition or performance, 3 months prior to the beginning of the trial.
  • Clinical diagnose of a disease that might compromise tolerance to the supplements or influence body composition or performance.

结局指标

主要结局

Performance parameter - change in peak power

时间窗: Baseline, week 4 and week 8

Muscle power (Watt) was assessed with a supramaximal cycling test on cycle ergometer

biochemical health markers - change in cortisol

时间窗: Baseline, week 4 and week 8

Salivary cortisol was assessed using spectrophotometry techniques in an automated equipment.

biochemical health markers - change in glucose

时间窗: Baseline, week 4 and week 8

plasma glucose was assessed using spectrophotometry techniques in an automated equipment.

Aerobic performance - change in Oxygen uptake

时间窗: Baseline, week 4 and week 8

VO2peak (mL.kg-1.min-1) was assessed using breath-by-breath gas analyzer in an incremental test performed on a treadmill

biochemical health markers - change in alanine aminotransferase

时间窗: Baseline, week 4 and week 8

Plasma alanine aminotransferase was assessed using spectrophotometry techniques in an automated equipment.

Body composition parameter - change in muscle thickness

时间窗: Baseline, week 4 and week 8

muscle thickness of the rectus femoris (mm) was assessed by ultrasonography

Performance parameter - change in jump height

时间窗: Baseline, week 4 and week 8

Vertical jump height (cm) was assessed on a multicomponent force platform interfaced with the Chronojump software

biochemical health markers - change in creatinine

时间窗: Baseline, week 4 and week 8

plasma creatinine was assessed using spectrophotometry techniques in an automated equipment.

biochemical health markers - change in Aspartate Aminotransferase

时间窗: Baseline, week 4 and week 8

plasma Aspartate Aminotransferase was assessed using spectrophotometry techniques in an automated equipment.

Body composition parameter - change in fat free mass (FFM)

时间窗: Baseline, week 4 and week 8

FFM (kg) was assessed by dual energy X-ray absorptiometry

Body composition parameter - change in body water

时间窗: Baseline, week 4 and week 8

total body water, intracellular water and extracellular water (L) were assessed by bioelectrical impedance analysis

Performance parameter - change in strength

时间窗: Baseline, week 4 and week 8

Maximal isometric forearm strength (N) was assessed using a handgrip dynamometer

Performance parameter - change in maximum strength

时间窗: Baseline, week 4 and week 8

Maximum strength (kg) was predicted from 1-RM in back squat and bench press exercises using a Multipower machine withVitruve technology

biochemical health markers - change in C reactive protein

时间窗: Baseline, week 4 and week 8

plasma C Reactive Protein was assessed using spectrophotometry techniques in an automated equipment.

Body composition parameter - change in fat mass (FM)

时间窗: Baseline, week 4 and week 8

FM (%) was assessed by dual energy X-ray absorptiometry

biochemical health markers - change creatine kinase

时间窗: Baseline, week 4 and week 8

plasma creatine kinase was assessed using spectrophotometry techniques in an automated equipment.

次要结局

  • Body composition parameter - change of visceral fat(Baseline, week 4 and week 8)
  • Body composition parameter - change in phase angle(Baseline, week 4 and week 8)

研究者

发起方
Bettery S.A.
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Filipe Teixeira

Innovation Manager

Bettery S.A.

研究点 (2)

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