The Prebiotic Effect of Daily Intake of Orange Juice Affects the Bioavailability of Flavanones?
- Conditions
- Intestinal Diseases
- Interventions
- Other: Orange juice
- Registration Number
- NCT03032861
- Lead Sponsor
- São Paulo State University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
Healthy women BMI 18.5 - 29.9 kg/m2.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Orange juice Orange juice Ten women will consume 100% orange juice (300 mL/day) during 60 days.
- Primary Outcome Measures
Name Time Method Determination of acetic acid 4 months Ammonium concentration 4 mounths Total counting of aerobic bacteria and facultative anaerobic bacteria 4 months Determination of butyric acid 4 months
- Secondary Outcome Measures
Name Time Method Insulin curve 4 mounths Low density lipoprotein cholesterol 4 mounths Insulin 4 mounths Total cholesterol 4 mounths GammaGT 4 mounths Glycemic curve 4 mounths Body lean mass 4 months Body fat mass 4 months % body fat 4 months Ratio waist/hip 4 mounths Glucose 4 mounths Bioavailability of hesperitin and naringenin in the blood, urine and feces 4 months Quantification of hesperidin and naringenin and identification and quantification of their metabolites in the blood, urine and feces
Body mass index 4 months 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
Trial Locations
- Locations (1)
Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
🇧🇷Araraquara, Sao Paulo, Brazil