Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans (METABORANGE).
NCT ID: NCT02685124
Last Updated: 2016-02-18
Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
21 participants
INTERVENTIONAL
2015-09-30
2016-02-29
Brief Summary
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Detailed Description
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Unlike the "Bahia", the "Cara Cara" variety which is a spontaneous mutation of "Washington navel" orange is characterized by a bright red pulp due to high levels of lycopene. This difference in the chemical composition may lead to a different biological activity and then a greater protective effect on health.
Since the biological effects generated from a food intake are the result of the interaction of various nutrients with different metabolic pathways, the investigators will apply the metabolomic approach to investigate the complex relationships between fruit intake, bioactive compounds and human metabolism. The investigators will propose to describe the metabolic pathways affected by orange juice intake and to identify biomarkers that can be used in nutritional interventions.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Bahia orange juice
250 ml twice daily for 7 days
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.
Cara Cara orange juice
250 ml twice daily for 7 days
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.
Isocaloric control drink
250 ml twice daily for 7 days
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of gastrointestinal, liver or kidney disease
* History of alcoholism
* Diabetes and metabolic diseases
* Pregnant, trying to became pregnant or breast feeding
* Smokers
* To make use of vitamin and mineral supplements, antibiotics, antiacids, any drugs
20 Years
45 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Elisa Brasili
Post doc researcher
Principal Investigators
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Elisa Brasili, PhD
Role: STUDY_DIRECTOR
University of Sao Paulo
Other Identifiers
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CEP FCF 1097907
Identifier Type: -
Identifier Source: org_study_id
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