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Orange Juice Supplementation in Soccer Players

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03209596
Enrollment
30
Registered
2017-07-06
Start date
2013-10-20
Completion date
2014-08-29
Last updated
2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Athletes

Keywords

Athletes, Food intake, Supplementation, Biochemical biomarkers, Soccer Players

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 Based on unpublished data from a previous pilot experiment, it was expected that the total cholesterol of orange juice group would be 10% lower in relation to control group after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

Interventions

DIETARY_SUPPLEMENTOrange 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.

DIETARY_SUPPLEMENTControl 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.

Sponsors

Citrosuco Company
CollaboratorINDUSTRY
Ellen Cristini de Freitas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, 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.

Eligibility

Sex/Gender
MALE
Age
18 Years to 19 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Food intake60 daysFood intake was assessed by 24-hour recall

Secondary

MeasureTime frameDescription
Total cholesterol60 daysBlood dosing using commercial kits
Low Density Lipoprotein Cholesterol (LDL-C)60 daysCalculated with an equation described by Friedewald et al. (1972)
High Density Lipoprotein Cholesterol (HDL-C)60 daysBlood dosing using commercial kits
Triglycerides60 daysBlood dosing using commercial kits
Creatinine60 daysBlood dosing using commercial kits
Glucose60 daysBlood dosing using commercial kits
Glycated hemoglobin60 daysBlood dosing using commercial kits

Other

MeasureTime frameDescription
% Lean body mass60 daysAssessed by deuterium oxide method
% Fat body mass60 daysAssessed by deuterium oxide method
% body water60 daysAssessed by deuterium oxide method
Body Mass Index (BMI kg/cm2)60 daysWeight and height will be combined to report BMI (kg/cm2) by the following equation: BMI (kg/cm2) = Weight (kg) / (Height (m))2

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026