Clinical trial NCT03209596: Orange Juice Supplementation in Soccer Players
Official title: Nutritional and Biochemical Effects of Orange Juice Supplementation in Soccer Players: a Double Blind, Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Athletes
Keywords: Athletes
Food intake
Supplementation
Biochemical biomarkers
Soccer Players
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Citrosuco Company
First posted: 2017-07-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after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

Eligibility 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.

Primary outcomes:
measure: Food intake
timeFrame: 60 days
Secondary outcomes:
measure: Glucose
timeFrame: 60 days
measure: Glycated hemoglobin
timeFrame: 60 days
measure: Total cholesterol
timeFrame: 60 days
measure: Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 60 days
measure: High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: 60 days
measure: Triglycerides
timeFrame: 60 days
measure: Creatinine
timeFrame: 60 days
Other outcomes:
measure: Body Mass Index (BMI kg/cm2)
timeFrame: 60 days
measure: % Lean body mass
timeFrame: 60 days
measure: % Fat body mass
timeFrame: 60 days
measure: % body water
timeFrame: 60 days
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
state: São Paulo
Study officials:
affiliation: University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
name: Ellen C De Freitas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sao Paulo State University "Julio de Mesquita Filho", Faculty of Pharmaceutical Sciences
name: Sara M Terrazas, Msc
role: STUDY_CHAIR
References:
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. No abstract available.
citation: 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.