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Completed

NCT Number: NCT03209596

Orange Juice Supplementation in Soccer Players

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.

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Key information

Conditions

Age range

18 year–19 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Ribeirão Preto, São Paulo, 14049-900, Brazil

About this study

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 Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orange juice (1L/d)

Dietary Supplement

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.

Control drink (1L/d)

Dietary Supplement

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.

Primary outcomes

  1. Food intake

    Time frame: 60 days

    Food intake was assessed by 24-hour recall

Secondary outcomes

  1. Glucose

    Time frame: 60 days

    Blood dosing using commercial kits

  2. Glycated hemoglobin

    Time frame: 60 days

    Blood dosing using commercial kits

  3. Total cholesterol

    Time frame: 60 days

    Blood dosing using commercial kits

  4. Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: 60 days

    Calculated with an equation described by Friedewald et al. (1972)

  5. High Density Lipoprotein Cholesterol (HDL-C)

    Time frame: 60 days

    Blood dosing using commercial kits

  6. Triglycerides

    Time frame: 60 days

    Blood dosing using commercial kits

  7. Creatinine

    Time frame: 60 days

    Blood dosing using commercial kits

Other outcomes

  1. Body Mass Index (BMI kg/cm2)

    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

  2. % Lean body mass

    Time frame: 60 days

    Assessed by deuterium oxide method

  3. % Fat body mass

    Time frame: 60 days

    Assessed by deuterium oxide method

  4. % body water

    Time frame: 60 days

    Assessed by deuterium oxide method

Sponsors and collaborators

Lead sponsor

Ellen Cristini de Freitas

Other

Collaborators

  • Citrosuco Company

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 6, 2017
Registry last updated
Jul 11, 2017

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.

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