NCT03032861

Brief Summary

This study aimed investigate the chronic effect of orange juice consumption on gut microbiota and in the bioavailability of flavanones and metabolites by feces, blood and urine analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1 month

First QC Date

January 6, 2017

Last Update Submit

April 25, 2017

Conditions

Intestinal Diseases

Keywords

Orange juiceMicrobiotaPrebioticFlavanonesBioavailability

Outcome Measures

Primary Outcomes (4)

  • Total counting of aerobic bacteria and facultative anaerobic bacteria

    4 months

  • Determination of butyric acid

    4 months

  • Determination of acetic acid

    4 months

  • Ammonium concentration

    4 mounths

Secondary Outcomes (19)

  • Bioavailability of hesperitin and naringenin in the blood, urine and feces

    4 months

  • Body mass index

    4 months

  • Body lean mass

    4 months

  • Body fat mass

    4 months

  • % body fat

    4 months

  • +14 more secondary outcomes

Study Arms (1)

Orange juice

EXPERIMENTAL

Ten women will consume 100% orange juice (300 mL/day) during 60 days.

Other: Orange juice

Interventions

Orange juiceOTHER

Thirty days before the beginning of trial, women (n= 10; BMI 23.8 kg/m2; 28 years) will be advised to not consumed foods containing prebiotic, probiotic and fibers, and citrus fruits and beverages. After 30 days, the participants will consume 300 mL of orange juice daily during 60 days. After 60 days of orange juice intervention, the participants will be submitted to 30 days of washout. Samples of blood, urine and feces will collect in five different occasions (baseline, 30 day, 60 day, 90 day, and 120 day) in order to evaluate the prebiotic effect of orange juice on gut microbiota and the bioavailability of its flavanones in blood, urine and feces.

Orange juice

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women BMI 18.5 - 29.9 kg/m2.

You may not qualify if:

  • Gastrointestinal diseases Pregnant women Regular use of medications Dietary restrictions, vegetarian diet, macrobiotic, etc. Use of vitamins or dietary supplements Use of probiotics or prebiotics in the last 3 months and antibiotics in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas

Araraquara, São Paulo, 14800-903, Brazil

Location

Related Publications (3)

  • Silveira JQ, Cesar TB, Manthey JA, Baldwin EA, Bai J, Raithore S. Pharmacokinetics of flavanone glycosides after ingestion of single doses of fresh-squeezed orange juice versus commercially processed orange juice in healthy humans. J Agric Food Chem. 2014 Dec 31;62(52):12576-84. doi: 10.1021/jf5038163. Epub 2014 Dec 15.

    PMID: 25495754RESULT

  • Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

    PMID: 11234459RESULT

  • Kanaze FI, Bounartzi MI, Georgarakis M, Niopas I. Pharmacokinetics of the citrus flavanone aglycones hesperetin and naringenin after single oral administration in human subjects. Eur J Clin Nutr. 2007 Apr;61(4):472-7. doi: 10.1038/sj.ejcn.1602543. Epub 2006 Oct 18.

    PMID: 17047689RESULT

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Thais B Cesar, PhD

    São Paulo State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 26, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

February 1, 2017

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

BR(1)