The Prebiotic Effect of Daily Intake of Orange Juice Affects the Bioavailability of Flavanones?

Influence of the Prebiotic Effect of Orange Juice on the Bioavailability of Flavanones After Chronic Intake of Orange Juice.

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Diseases
• Intervention / Treatment: Other: Orange juice

Detailed Description

Non-randomized study with interrupted time series and open-label, in which women were enrolled and advised to not consumed foods containing prebiotic, probiotic and fibers, and citrus fruits and beverages during 30 days before of intervention (n=10; BMI 23.8 kg/m2; 28 years). After 30 days, the participants will consume during 60 days 300 mL of orange juice daily. 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 in the bioavailability of its flavanones. The recruitment process began in September 2016 and the intervention was carried out from October 2016 to February 2017, and the data analysis will start in February 2017. The sample number took into account variances on blood hesperitin levels with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Silveira et al., 2015). The minimum sample size should have six individuals into the same group. Considering an approximately 15% dropout rate, the final sample size of study was constituted by 10 women. Primary endpoint is the changes in total bacteria population (Lactobacillus spp., Bifidobacterium spp., and reduction of Clostridium spp.) that can result in increased of butyric, acetic, and propionic acid concentrations, and reduction of ammonium production. Secondary endpoint is enhancement of bioavailability of flavanones (hesperitin, naringenin) and metabolites in the blood, urine and feces. Kolmogorov Smirnov and Levene test will be used to assess the normality and homogeneity of data, respectively. One-way analysis of variance (ANOVA) will be apply to determine the intervention effect over the time 0, 30 day, 60 day, 90 day, and 120 day). P significance was set up ≤ 0.05.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Araraquara, Sao Paulo, Brazil, 14800-903
      • Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

Healthy women BMI 18.5 - 29.9 kg/m2.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: Orange juice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioavailability of hesperitin and naringenin in the blood, urine and feces	Quantification of hesperidin and naringenin and identification and quantification of their metabolites 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
Ratio waist/hip		4 mounths
Glucose		4 mounths
Insulin		4 mounths
Total cholesterol		4 mounths
Low density lipoprotein cholesterol		4 mounths
High density lipoprotein cholesterol		4 mounths
Triglycerides		4 mounths
hsCRP		4 mounths
Alkaline phosphatase		4 mounths
Aspartate enzyme aminotransferase		4 mounths
Alanine enzyme aminotransferase		4 mounths
GammaGT		4 mounths
Glycemic curve		4 mounths
Insulin curve		4 mounths

Collaborators and Investigators

• Sponsor: São Paulo State University
• Investigators: Principal Investigator: Thais B Cesar, PhD, São Paulo State University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Microbiota; Prebiotic; Bioavailability; Orange juice; Flavanones
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: SaoPSU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.