The Prebiotic Effect of Daily Intake of Orange Juice Affects the Bioavailability of Flavanones?
Condition: Intestinal Diseases
MeSH terms: Intestinal Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): Orange juice
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Orange juice; Microbiota; Prebiotic; Flavanones; Bioavailability