Clinical trial NCT03032861: The Prebiotic Effect of Daily Intake of Orange Juice Affects the Bioavailability of Flavanones?
Official title: Influence of the Prebiotic Effect of Orange Juice on the Bioavailability of Flavanones After Chronic Intake of Orange Juice.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Diseases
Keywords: Orange juice
Microbiota
Prebiotic
Flavanones
Bioavailability
Lead sponsor: São Paulo State University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total counting of aerobic bacteria and facultative anaerobic bacteria
timeFrame: 4 months
measure: Determination of butyric acid
timeFrame: 4 months
measure: Determination of acetic acid
timeFrame: 4 months
measure: Ammonium concentration
timeFrame: 4 mounths
Secondary outcomes:
measure: Bioavailability of hesperitin and naringenin in the blood, urine and feces
timeFrame: 4 months
measure: Body mass index
timeFrame: 4 months
measure: Body lean mass
timeFrame: 4 months
measure: Body fat mass
timeFrame: 4 months
measure: % body fat
timeFrame: 4 months
measure: Ratio waist/hip
timeFrame: 4 mounths
measure: Glucose
timeFrame: 4 mounths
measure: Insulin
timeFrame: 4 mounths
measure: Total cholesterol
timeFrame: 4 mounths
measure: Low density lipoprotein cholesterol
timeFrame: 4 mounths
measure: High density lipoprotein cholesterol
timeFrame: 4 mounths
measure: Triglycerides
timeFrame: 4 mounths
measure: hsCRP
timeFrame: 4 mounths
measure: Alkaline phosphatase
timeFrame: 4 mounths
measure: Aspartate enzyme aminotransferase
timeFrame: 4 mounths
measure: Alanine enzyme aminotransferase
timeFrame: 4 mounths
measure: GammaGT
timeFrame: 4 mounths
measure: Glycemic curve
timeFrame: 4 mounths
measure: Insulin curve
timeFrame: 4 mounths
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
state: Sao Paulo
Study officials:
affiliation: São Paulo State University
name: Thais B Cesar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 Dec 31;62(52):12576-84. doi: 10.1021/jf5038163. Epub 2014 Dec 15.
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.
citation: 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. doi: 10.1038/sj.ejcn.1602543. Epub 2006 Oct 18.