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临床试验/NCT03209596
NCT03209596已完成不适用

Nutritional and Biochemical Effects of Orange Juice Supplementation in Soccer Players: a Double Blind, Randomized and Controlled Trial

Ellen Cristini de Freitas2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年10月20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
30
试验地点
2
主要终点
Food intake

研究概览

简要总结

This study aimed to verify if orange juice supplementation can be a nutritional strategy to ensure an adequate energy and micronutrients ingestion, influencing metabolic responses of soccer players.

详细描述

Thirty-four male soccer players aged 18.5 ± 0.5 years and BMI (Body Mass Index) of 21.41 ± 1.48 kg/cm2 were randomly divided into two parallel groups: (1) orange juice (n = 17), composed of individuals receiving 1 liter/day of orange juice; (2) control (n = 17) composed of individuals receiving 1 liter/day of control drink with the same proportion of total sugars as the orange juice. The recruitment process began in September 2013, the intervention was carried out from November 2013 to January 2014, and the data analysis started in February 2014. The sample size took into account the variances in total cholesterol, considering the high statistical variability of biochemical markers, which requires a sufficient number of samples to ensure representativeness and adequate statistical power of analysis, and that the reduction of total cholesterol is associated to the regular consumption of orange juice (Dourado et al., 2015). Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after intervention (orange juice = 123.41 ± 12.12 mg/dL, control drink = 37.80 ± 11.17 mg/dL). Thus, with a type I error α = 0.05 and a type II error β = 0.2 (80% power) the minimum sample size should have 12 individuals per group (n = 24). Considering the high layoffs rate in the team, the initial sample size of study was constituted by 17 individuals per group (n = 34). During the intervention, four individuals from control drink group failed the study protocol, and the study was concluded with 30 participants (orange juice n = 17 and control drink n = 13). Primary and secondary endpoints were the improvement of food intake and changes in biochemical markers, respectively. Shapiro Wilk and Levene tests evaluated normality and homogeneity of data, respectively. T-test was conducted to identify possible differences between groups at baseline. A mixed factorial ANOVA was applied to determine the effect of treatment and time, within and between groups (Sidak post hoc test), and statistical significance was set at p < 0.05. Food intake, biochemical biomarkers and body composition were assessed before and after the 60 days of intervention.

研究设计

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

盲法说明

All assignments and group randomization were performed by a research team member who was not directly involved in the study. The masking of the volunteers was performed by the control drink. For statistical analysis of the results, the masking was maintained by conferring fictitious names to the groups.

入排标准

年龄范围
18 Years 至 19 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Three consecutive years of soccer training prior to the start of the study.

排除标准

  • Historic of chronic disease, use of hormones, drugs, vitamins supplements and/or other dietary supplements during the study.

结局指标

主要结局

Food intake

时间窗: 60 days

Food intake was assessed by 24-hour recall

次要结局

  • Glucose(60 days)
  • Glycated hemoglobin(60 days)
  • Total cholesterol(60 days)
  • Low Density Lipoprotein Cholesterol (LDL-C)(60 days)
  • High Density Lipoprotein Cholesterol (HDL-C)(60 days)
  • Triglycerides(60 days)
  • Creatinine(60 days)

研究者

发起方
Ellen Cristini de Freitas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ellen Cristini de Freitas

PhD

University of Sao Paulo

研究点 (2)

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