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临床试验/NCT04621383
NCT04621383已完成不适用

Effects of Whey Protein Supplementation with Hydrolyzed Collagen Associated with 12 Weeks of Resistance Training on Body Composition, Blood Biomarkers and Muscle Strength in Elderly Women

Universidade Estadual de Londrina2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2019年5月27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
67
试验地点
2
主要终点
Change in body composition

研究概览

简要总结

The main purpose of the present study was to investigate the effects of whey protein with collagen hydrolyzed following resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women

详细描述

his two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 17 weeks. At the beginning of the experiment, two weeks and at the end three weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16), magnetic ressonance imaging (weeks 2 and 17) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.

Recruitment was carried out through newspapers, radio advertising, and home delivery of leaflets in the central area and residential neighborhoods. All participants completed health history and physical activity questionnaires and were included in the study if they met the following inclusion criteria: 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction that would prevent them from performing the prescribed exercise or exercise testing associated with the study, not receiving hormonal replacement therapy, and completed a previous 8-week RT programParticipants underwent a diagnostic graded exercise stress test with a 12-lead electrocardiogram reviewed by a cardiologist and were released with no restrictions for participation in this investigation.

A blinded researcher was responsible for generating random numbers for participant allocation. Both groups were submitted to the same RT program and all participants completed the experiment. Written informed consent was obtained from all participants after a detailed description of investigation procedures was provided. This investigation was conducted according to the Declaration of Helsinki and was approved by the local University Ethics Committee The Shapiro Wilk test will be used to test data distribution. Data will be presented as means, standard deviation, and z-score. The student's independent t-test and chi-square test were will be used to compare groups regarding the general characteristics and clinical/medical history (categorical variables). Two-way analysis of variance (ANOVA) for repeated measures will be used to assess between group comparisons. The effect size (ES) will be calculated to verify the magnitude of the differences by Cohen's d, where an ES of 0.20-0.49 will be considered as small, 0.50-0.79 as moderate, and ≥ 0.80 as large(41). The Z-score of the percentage changes (from pre- to post-training) of the raw data for each parameter will be calculated, as well as a total Z-score, derived from all the components. To verify the differences between groups in total Z-scores, an independent T test will be also applied. For all statistical analyses, significance was accepted at P < 0.05. The data will be analyzed using SPSS software version 20.0 (SPSS, Inc., Chicago, IL, USA).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction that would prevent them from performing the prescribed exercise or exercise testing associated with the study, not receiving hormonal replacement therapy, and completed a previous 8-week RT program. In this study, only women with SO were included. SO was defined as a body fat mass ≥ 35% combined with appendicular lean soft tissue (ALST) less than <15.02 kg, assessed by dual x-ray energy absorptiometry (DXA). Participants underwent a diagnostic graded exercise stress test with a 12-lead electrocardiogram reviewed by a cardiologist and were released with no restrictions for participation in this investigation.

排除标准

  • All subjects not participating in 85% of the total sessions of training or withdraw

结局指标

主要结局

Change in body composition

时间窗: baseline and after 12 weeks

Whole-body dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy) was used to assess lean mass and fat mass and its segments. The total skeletal muscle mass (SMM) was estimated by the predictive equation proposed by Kim et al. (Kim et al., 2004). The results are presented in kg.

Change in Muscular strength

时间窗: baseline and after 12 weeks

Maximal dynamic strength was evaluated using the 1RM test assessed on chest press, knee extension, and preacher curl exercises performed in this exact order. Testing for each exercise was preceded by a warm-up set (6-10 repetitions), with approximately 50% of the estimated load used in the first attempt of the 1RM. This warm-up was also used to familiarize the subjects with the testing equipment and lifting technique. The testing procedure was initiated 2 minutes after the warm-up. The subjects were instructed to try to accomplish two repetitions with the imposed load in three attempts in both exercises. The rest period was 3 to 5 min between each attempt, and 5 min between exercises. The 1RM was recorded as the last resistance lifted in which the subject was able to complete only one single maximal execution

Change in knee cartilage

时间窗: baseline and after 12 weeks

Magnetic resonance imaging was used to access the thickness of knee cartilage in multiaxial protocol. the total cartilage was measured by a trained tecnician on images. The results are presented in mm.

次要结局

  • Change in low-density lipoprotein(baseline and after 12 weeks)
  • Change in HOMA-IR(baseline and after 12 weeks)
  • Change in high-density lipoprotein (HDL-C)(baseline and after 12 weeks)
  • Change in height(baseline and after 12 weeks)
  • Change in glucose(baseline and after 12 weeks)
  • Change in inflammatory markers(baseline and after 12 weeks)
  • Change in Uric acid(baseline and after 12 weeks)
  • Change in Creatinine(baseline and after 12 weeks)
  • Change in triglycerides(baseline and after 12 weeks)
  • Change in body mass index(baseline and after 12 weeks)
  • Change in waist circumference(baseline and after 12 weeks)
  • Change in hip circumference(baseline and after 12 weeks)
  • Change in Urea(baseline and after 12 weeks)
  • Change in Total cholesterol(Measurements of serum levels of total cholesterol were determined using a biochemical auto-analyzer system (Dimension Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations.)
  • Change in insulin(baseline and after 12 weeks)
  • Change in body mass(baseline and after 12 weeks)
  • Change in hepatic markers(baseline and after 12 weeks)
  • Change in blood pressure(baseline and after 12 weeks)
  • Dietary intake(baseline and after 12 weeks)
  • Change in C-reactive protein (CRP)(baseline and after 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edilson Serpeloni Cyrino

Principal Investigator

Universidade Estadual de Londrina

研究点 (2)

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