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Orange Juice Supplementation in Soccer Players

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ClinicalTrials.gov Identifier: NCT03209596
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Citrosuco Company
Information provided by (Responsible Party):
Ellen Cristini de Freitas, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Athletes Dietary Supplement: Orange juice (1L/d) Dietary Supplement: Control drink (1L/d) Not Applicable

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 Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Nutritional and Biochemical Effects of Orange Juice Supplementation in Soccer Players: a Double Blind, Randomized and Controlled Trial
Actual Study Start Date : October 20, 2013
Actual Primary Completion Date : January 31, 2014
Actual Study Completion Date : August 29, 2014

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.




Primary Outcome Measures :
  1. Food intake [ Time Frame: 60 days ]
    Food intake was assessed by 24-hour recall


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 19 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209596


Locations
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Brazil
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
Ribeirão Preto, São Paulo, Brazil, 14049-900
Sponsors and Collaborators
Ellen Cristini de Freitas
Citrosuco Company
Investigators
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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

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Ellen Cristini de Freitas, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03209596     History of Changes
Other Study ID Numbers: ECdeFreitas
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ellen Cristini de Freitas, University of Sao Paulo:
Athletes
Food intake
Supplementation
Biochemical biomarkers
Soccer Players