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

Intestinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032861
• Other study ID #: SaoPSU2
• Status: Completed
• Phase: N/A
• First received: January 6, 2017
• Last updated: April 25, 2017
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: São Paulo State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Brazil	Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas	Araraquara	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
São Paulo State University

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Epub 2006 Oct 18. — View Citation

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

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total counting of aerobic bacteria and facultative anaerobic bacteria		4 months
Primary	Determination of butyric acid		4 months
Primary	Determination of acetic acid		4 months
Primary	Ammonium concentration		4 mounths
Secondary	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
Secondary	Body mass index		4 months
Secondary	Body lean mass		4 months
Secondary	Body fat mass		4 months
Secondary	% body fat		4 months
Secondary	Ratio waist/hip		4 mounths
Secondary	Glucose		4 mounths
Secondary	Insulin		4 mounths
Secondary	Total cholesterol		4 mounths
Secondary	Low density lipoprotein cholesterol		4 mounths
Secondary	High density lipoprotein cholesterol		4 mounths
Secondary	Triglycerides		4 mounths
Secondary	hsCRP		4 mounths
Secondary	Alkaline phosphatase		4 mounths
Secondary	Aspartate enzyme aminotransferase		4 mounths
Secondary	Alanine enzyme aminotransferase		4 mounths
Secondary	GammaGT		4 mounths
Secondary	Glycemic curve		4 mounths
Secondary	Insulin curve		4 mounths

External Links

•   An exploratory study on the influence of orange juice on gut microbiota using a dynamic colonic model