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Completed

NCT Number: NCT02685124

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

The consumption of fruits and vegetables is linked to a decrease in the incidence of chronic diseases. Citrus fruits represent the main source of bioactive compounds such as flavonoids, vitamin C and carotenoids in the brazilian diet.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects like to drink orange juice

Exclusion criteria

  • History of cardiovascular disease
  • 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

Treatment and study plan

Orange Juice

Dietary Supplement

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.

Primary outcomes

  1. Qualitative changes in urinary metabolome will be evaluated by Gas Chromatography coupled to Mass Spectrometry (GC-MS) and Liquid Chromatography coupled to Mass Spectrometry (LC-MS).

    Time frame: Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.

Secondary outcomes

  1. Changes in the antioxidant enzymes will be evaluated in serum samples in different time points.

    Time frame: Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment

  2. Changes in the miRNAs expression will be evaluated in plasma samples in different time points.

    Time frame: Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment

  3. Qualitative and quantitative changes in fecal metabolome will be evaluated by an untargeted metabolomic approach based on Nuclear Magnetic Resonance spectroscopy (NMR).

    Time frame: Feces collection will be performed at time 0 and after 7 days of treatment.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Metabolomic Approach to Evaluate the Effect of Orange Juice Intake in Healthy Humans: a Comparative Study Between "Bahia" and "Cara Cara" Orange Varieties.

Acronym: METABORANGE

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 18, 2016
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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