University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
Ribeirão Preto, São Paulo, 14049-900, Brazil
NCT Number: NCT03209596
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.
Looking for future studies?
Notify Me18 year–19 year
Male
Interventional
Not applicable
Ribeirão Preto, São Paulo, 14049-900, Brazil
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 Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The players (n=17) drank 1 liter per day of orange juice. We do not interfere on the volunteers' usual diet during the study, and they did not ingest any commercial nutritional supplements in this period. During the intervention, the volunteers were engaged in a common training routine specified by the coach's team.
The players (n=13) drank 1 liter per day of the control drink during a 60-day period. We do not interfere on the volunteers' usual diet during the study, and they did not ingest any commercial nutritional supplements in this period. During the intervention, the volunteers were engaged in a common training routine specified by the coach's team.
Time frame: 60 days
Food intake was assessed by 24-hour recall
Time frame: 60 days
Blood dosing using commercial kits
Time frame: 60 days
Blood dosing using commercial kits
Time frame: 60 days
Blood dosing using commercial kits
Time frame: 60 days
Calculated with an equation described by Friedewald et al. (1972)
Time frame: 60 days
Blood dosing using commercial kits
Time frame: 60 days
Blood dosing using commercial kits
Time frame: 60 days
Blood dosing using commercial kits
Time frame: 60 days
Weight and height will be combined to report BMI (kg/cm2) by the following equation: BMI (kg/cm2) = Weight (kg) / (Height (m))2
Time frame: 60 days
Assessed by deuterium oxide method
Time frame: 60 days
Assessed by deuterium oxide method
Time frame: 60 days
Assessed by deuterium oxide method
Ellen Cristini de Freitas
Other
Nutritional and Biochemical Effects of Orange Juice Supplementation in Soccer Players: a Double Blind, Randomized and Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06892262
Healthy Athletes
Ankara, Yenimahalle, Turkey (Türkiye)
View Trial DetailsNCT04073849
Healthy Athletes
Salt Lake City, Utah, United States
View Trial DetailsNCT04444388
Healthy Athletes
Villaviciosa de Odón, Madrid, Spain
View Trial DetailsNCT02370368
Healthy Athletes
View Trial Details