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

Healthy Volunteers Clinical Trial

— METABORANGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685124
• Other study ID #: CEP FCF 1097907
• Status: Completed
• Phase: Phase 0
• First received: February 4, 2016
• Last updated: February 12, 2016
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Urine collection will be performed at time 0, after 3, 6 hours and 7 days of treatment.	Yes
Secondary	Changes in the antioxidant enzymes will be evaluated in serum samples in different time points.		Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment	Yes
Secondary	Changes in the miRNAs expression will be evaluated in plasma samples in different time points.		Blood collection will be performed at time 0, after 3, 6 hours and 7 days of treatment	Yes
Secondary	Qualitative and quantitative changes in fecal metabolome will be evaluated by an untargeted metabolomic approach based on Nuclear Magnetic Resonance spectroscopy (NMR).		Feces collection will be performed at time 0 and after 7 days of treatment.	Yes