NCT03209596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

June 21, 2017

Last Update Submit

July 5, 2017

Conditions

Healthy Athletes

Keywords

AthletesFood intakeSupplementationBiochemical biomarkersSoccer Players

Outcome Measures

Primary Outcomes (1)

  • Food intake

    Food intake was assessed by 24-hour recall

    60 days

Secondary Outcomes (7)

  • Glucose

    60 days

  • Glycated hemoglobin

    60 days

  • Total cholesterol

    60 days

  • Low Density Lipoprotein Cholesterol (LDL-C)

    60 days

  • High Density Lipoprotein Cholesterol (HDL-C)

    60 days

  • +2 more secondary outcomes

Other Outcomes (4)

  • Body Mass Index (BMI kg/cm2)

    60 days

  • % Lean body mass

    60 days

  • % Fat body mass

    60 days

  • +1 more other outcomes

Study Arms (2)

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.

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.

Dietary Supplement: Control drink (1L/d)

Interventions

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.

Orange juice
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.

Control drink

Eligibility Criteria

Age18 Years - 19 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Three consecutive years of soccer training prior to the start of the study.

You may not qualify if:

  • Historic of chronic disease, use of hormones, drugs, vitamins supplements and/or other dietary supplements during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 4337382BACKGROUND

  • 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.

    PMID: 26490535RESULT

Study Officials

  • Ellen C De Freitas, Ph.D.

    University of São Paulo, School of Physical Education and Sports of Ribeirão Preto

    PRINCIPAL INVESTIGATOR

  • Sara M Terrazas, Msc

    Sao Paulo State University "Julio de Mesquita Filho", Faculty of Pharmaceutical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 21, 2017

First Posted

July 6, 2017

Study Start

October 20, 2013

Primary Completion

January 31, 2014

Study Completion

August 29, 2014

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)