Healthy AthletesNCT03209596
Orange Juice Supplementation in Soccer Players
A study testing Orange juice (1L/d) in people with Healthy Athletes, run by Ellen Cristini de Freitas at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Athletes
- What is being tested?
- Orange juice (1L/d)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2013to 29 Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 19 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Three consecutive years of soccer training prior to the start of the study.
Who cannot join
- Historic of chronic disease, use of hormones, drugs, vitamins supplements and/or other dietary supplements during the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: Nutritional and Biochemical Effects of Orange Juice Supplementation in Soccer Players: a Double Blind, Randomized and Controlled Trial
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.
Read the 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.
- Conditions
- Healthy Athletes
- Being tested
- Orange juice (1L/d), Control drink (1L/d)
- Keywords
- Athletes, Food intake, Supplementation, Biochemical biomarkers, Soccer Players
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Orange juice | Experimental | 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. Receives: Dietary Supplement: Orange juice (1L/d) |
| Control drink | Active comparator | 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. Receives: Dietary Supplement: Control drink (1L/d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Food intake was assessed by 24-hour recall
Measured: 60 days
Secondary outcomes (7)
Glucose
Blood dosing using commercial kits
Measured: 60 days
Glycated hemoglobin
Blood dosing using commercial kits
Measured: 60 days
Total cholesterol
Blood dosing using commercial kits
Measured: 60 days
Low Density Lipoprotein Cholesterol (LDL-C)
Calculated with an equation described by Friedewald et al. (1972)
Measured: 60 days
High Density Lipoprotein Cholesterol (HDL-C)
Blood dosing using commercial kits
Measured: 60 days
Triglycerides
Blood dosing using commercial kits
Measured: 60 days
Creatinine
Blood dosing using commercial kits
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start20 Oct 2013
- Primary completion31 Jan 2014
- Study completion29 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellen Cristini de Freitas
- Sponsor type
- University, hospital or other
- Collaborators
- Citrosuco Company
- Responsible party
- Sponsor-investigator, Ellen Cristini de Freitas, University of Sao Paulo
- Investigators
- Ellen C De Freitas, Ph.D., Principal investigator, University of São Paulo, School of Physical Education and Sports of Ribeirão PretoSara M Terrazas, Msc, Study chair, Sao Paulo State University "Julio de Mesquita Filho", Faculty of Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209596
- Sponsor's protocol ID
- ECdeFreitas
- Status last verified
- Jul 2017
- First submitted
- 21 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 4337382Dourado 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.
PubMed 26490535
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Biochemical Effects of Orange Juice Supplementation in Soccer Players: a Double Blind, Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT03209596
- Acronym / sponsor ID
- ECdeFreitas
- Conditions
- Healthy Athletes
- Keywords
- Athletes, Food intake, Supplementation, Biochemical biomarkers, Soccer Players
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ellen Cristini de FreitasUniversity, hospital or other
- Collaborators
- Citrosuco Company
- Study start
- 20 Oct 2013 (actual)
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 29 Aug 2014 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange juice | Experimental | Dietary Supplement: Orange juice (1L/d)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. |
| Control drink | Active comparator | Dietary Supplement: Control drink (1L/d)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. |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Three consecutive years of soccer training prior to the start of the study.
Key exclusion criteria (1 listed)
- Historic of chronic disease, use of hormones, drugs, vitamins supplements and/or other dietary supplements during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Orange juice |
| 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. | Dietary supplement | Control drink |
Primary outcome
Food intake
Time frame: 60 days
Food intake was assessed by 24-hour recall
7 secondary outcomes
Glucose
Time frame: 60 days
Glycated hemoglobin
Time frame: 60 days
Total cholesterol
Time frame: 60 days
Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: 60 days
High Density Lipoprotein Cholesterol (HDL-C)
Time frame: 60 days
Triglycerides
Time frame: 60 days
Creatinine
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Background: PubMed 4337382Friedewald 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.
- Results publication: PubMed 26490535Dourado 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen C De Freitas, Ph.D. principal investigator
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
Sara M Terrazas, Msc study chair
Sao Paulo State University "Julio de Mesquita Filho", Faculty of Pharmaceutical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice (1L/d) in people with Healthy Athletes, run by Ellen Cristini de Freitas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209596, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.