Orange Juice Supplementation in Soccer Players

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Athletes
• Intervention / Treatment: Dietary supplement: Orange juice (1L/d); Dietary supplement: Control drink (1L/d)

Detailed Description

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 Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14049-900
      • University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 19 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orange juice; 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); 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.
Active Comparator: Control drink; 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); 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI kg/cm2)	Weight and height will be combined to report BMI (kg/cm2) by the following equation: BMI (kg/cm2) = Weight (kg) / (Height (m))2	60 days
% Lean body mass	Assessed by deuterium oxide method	60 days
% Fat body mass	Assessed by deuterium oxide method	60 days
% body water	Assessed by deuterium oxide method	60 days

Collaborators and Investigators

• Sponsor: Ellen Cristini de Freitas
• Collaborators: Citrosuco Company
• Investigators: Principal Investigator: Ellen C De Freitas, Ph.D., University of São Paulo, School of Physical Education and Sports of Ribeirão Preto; Study Chair: Sara M Terrazas, Msc, Sao Paulo State University "Julio de Mesquita Filho", Faculty of Pharmaceutical Sciences

Publications and helpful links

General Publications

• Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
• Dourado GK, Cesar TB. Investigation of cytokines, oxidative stress, metabolic, and inflammatory biomarkers after orange juice consumption by normal and overweight subjects. Food Nutr Res. 2015 Oct 20;59:28147. doi: 10.3402/fnr.v59.28147. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2013
• Primary Completion (Actual): January 31, 2014
• Study Completion (Actual): August 29, 2014

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Supplementation; Athletes; Food intake; Biochemical biomarkers; Soccer Players
• Other Study ID Numbers: ECdeFreitas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No