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.
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
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
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.
Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
Araraquara, São Paulo, Brazil
Total counting of aerobic bacteria and facultative anaerobic bacteria
Time frame: 4 months
Determination of butyric acid
Time frame: 4 months
Determination of acetic acid
Time frame: 4 months
Ammonium concentration
Time frame: 4 mounths
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
Time frame: 4 months
Body mass index
Time frame: 4 months
Body lean mass
Time frame: 4 months
Body fat mass
Time frame: 4 months
% body fat
Time frame: 4 months
Ratio waist/hip
Time frame: 4 mounths
Glucose
Time frame: 4 mounths
Insulin
Time frame: 4 mounths
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total cholesterol
Time frame: 4 mounths
Low density lipoprotein cholesterol
Time frame: 4 mounths
High density lipoprotein cholesterol
Time frame: 4 mounths
Triglycerides
Time frame: 4 mounths
hsCRP
Time frame: 4 mounths
Alkaline phosphatase
Time frame: 4 mounths
Aspartate enzyme aminotransferase
Time frame: 4 mounths
Alanine enzyme aminotransferase
Time frame: 4 mounths
GammaGT
Time frame: 4 mounths
Glycemic curve
Time frame: 4 mounths
Insulin curve
Time frame: 4 mounths