Orange Juice Supplementation in Soccer Players

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after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.

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

Conditions
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Healthy Athletes

Intervention / Treatment
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* Dietary Supplement: Orange juice (1L/d)
* Dietary Supplement: Control drink (1L/d)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Three consecutive years of soccer training prior to the start of the study. Exclusion Criteria: Historic of chronic disease, use of hormones, drugs, vitamins supplements and/or other dietary supplements during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orange juice<br>Seventeen individuals received 1 liter/day of pasteurized orange juice. Participants consumed the orange juice before and post exercise, the volume of juice per serving was 500 mL. On players' rest days, the juice was consumed throughout the day. | Dietary Supplement: Orange juice (1L/d)<br>* 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.<br>|
| Active Comparator: Control drink<br>Thirteen individuals received 1 liter/day of control drink. The participants consumed the control drink before and post exercise, the volume of drink per serving was 500 mL. On players' rest days, the drink was consumed throughout the day. The control drink consisted of an aqueous solution containing sucrose (44 g), glucose (22 g), fructose (22 g), citric acid (11g) (proportionally 2:1:1:0.5) (USDA, 2016) (with the same proportion of total sugars as the orange juice, and without all others bioactive compounds of juice), dyestuff sunset yellow (0.05 g) and orange essence. | Dietary Supplement: Control drink (1L/d)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food intake | Food intake was assessed by 24-hour recall | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | Blood dosing using commercial kits | 60 days | 
| Glycated hemoglobin | Blood dosing using commercial kits | 60 days | 
| Total cholesterol | Blood dosing using commercial kits | 60 days | 
| Low Density Lipoprotein Cholesterol (LDL-C) | Calculated with an equation described by Friedewald et al. (1972) | 60 days | 
| High Density Lipoprotein Cholesterol (HDL-C) | Blood dosing using commercial kits | 60 days | 
| Triglycerides | Blood dosing using commercial kits | 60 days | 
| Creatinine | Blood dosing using commercial kits | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Athletes, Food intake, Supplementation, Biochemical biomarkers, Soccer Players