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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intestinal Diseases

Intervention / Treatment
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* Other: Orange juice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orange juice<br>Ten women will consume 100% orange juice (300 mL/day) during 60 days. | Other: Orange juice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prebiotic, Orange juice, Microbiota, Flavanones, Bioavailability