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Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans (METABORANGE).

NCT02685124 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-02-18

No results posted yet for this study

Summary

This study evaluates the effect of intake of two orange juice varieties in healthy adults. The participants will receive "Bahia" orange juice, "Cara-Cara" orange juice or a isocaloric control drink in a cross-over study.

Conditions

  • Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

Orange juice

Three days before the start of the study, all participants will restrict their diet avoiding citrus fruits (orange, tangerine, lemon) and its derivatives (washout period), red fruits and vegetables (strawberry, red lettuce, red grape, tomate). The day before the sample collection will be provided a controlled dinner. A fasting for 8 hours will be required before blood and urine collection. All participants will divided into three groups: I (Cara Cara), II (Bahia), III (Isocaloric control drink). They will consume 250 ml of each drink twice daily for 7 consecutive days, with a washout period of 7 days among each intervention.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Elisa Brasili, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-10-31
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685124 on ClinicalTrials.gov