NCT02685124

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P50-P75 for early_phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2015

Shorter than P25 for early_phase_1 healthy-volunteers

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

1 month

First QC Date

February 4, 2016

Last Update Submit

February 12, 2016

Conditions

Healthy Volunteers

Outcome Measures

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).

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

Secondary Outcomes (3)

  • 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

  • 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

  • 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.

Study Arms (3)

Bahia orange juice

EXPERIMENTAL

250 ml twice daily for 7 days

Dietary Supplement: Orange juice

Cara Cara orange juice

EXPERIMENTAL

250 ml twice daily for 7 days

Dietary Supplement: Orange juice

Isocaloric control drink

PLACEBO COMPARATOR

250 ml twice daily for 7 days

Dietary Supplement: Orange juice

Interventions

Orange juiceDIETARY_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.

Bahia orange juiceCara Cara orange juiceIsocaloric control drink

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects like to drink orange juice

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Elisa Brasili, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doc researcher

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 18, 2016

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

February 1, 2016

Last Updated

February 18, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

February 2017