Orange Juice Supplementation in Soccer Players

Healthy Athletes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209596
• Other study ID #: ECdeFreitas
• Status: Completed
• Phase: N/A
• First received: June 21, 2017
• Last updated: July 5, 2017
• Start date: October 20, 2013
• Est. completion date: August 29, 2014

Study information

• Verified date: July 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 29, 2014
• Est. primary completion date: January 31, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Athletes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Ellen Cristini de Freitas	Citrosuco Company

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	% Lean body mass	Assessed by deuterium oxide method	60 days
Other	% Fat body mass	Assessed by deuterium oxide method	60 days
Other	% body water	Assessed by deuterium oxide method	60 days
Primary	Food intake	Food intake was assessed by 24-hour recall	60 days
Secondary	Glucose	Blood dosing using commercial kits	60 days
Secondary	Glycated hemoglobin	Blood dosing using commercial kits	60 days
Secondary	Total cholesterol	Blood dosing using commercial kits	60 days
Secondary	Low Density Lipoprotein Cholesterol (LDL-C)	Calculated with an equation described by Friedewald et al. (1972)	60 days
Secondary	High Density Lipoprotein Cholesterol (HDL-C)	Blood dosing using commercial kits	60 days
Secondary	Triglycerides	Blood dosing using commercial kits	60 days
Secondary	Creatinine	Blood dosing using commercial kits	60 days

External Links

•   USDA: United States Department of Agriculture. National Nutrient Database for Standard Reference, Release 28.