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

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ClinicalTrials.gov Identifier: NCT03032861
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Thais Cesar, 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.

Condition or disease Intervention/treatment Phase
Intestinal Diseases Other: Orange juice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of the Prebiotic Effect of Orange Juice on the Bioavailability of Flavanones After Chronic Intake of Orange Juice.
Actual Study Start Date : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Orange juice
Ten women will consume 100% orange juice (300 mL/day) during 60 days.
Other: Orange juice
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.




Primary Outcome Measures :
  1. Total counting of aerobic bacteria and facultative anaerobic bacteria [ Time Frame: 4 months ]
  2. Determination of butyric acid [ Time Frame: 4 months ]
  3. Determination of acetic acid [ Time Frame: 4 months ]
  4. Ammonium concentration [ Time Frame: 4 mounths ]

Secondary Outcome Measures :
  1. Bioavailability of hesperitin and naringenin in the blood, urine and feces [ Time Frame: 4 months ]
    Quantification of hesperidin and naringenin and identification and quantification of their metabolites in the blood, urine and feces

  2. Body mass index [ Time Frame: 4 months ]
  3. Body lean mass [ Time Frame: 4 months ]
  4. Body fat mass [ Time Frame: 4 months ]
  5. % body fat [ Time Frame: 4 months ]
  6. Ratio waist/hip [ Time Frame: 4 mounths ]
  7. Glucose [ Time Frame: 4 mounths ]
  8. Insulin [ Time Frame: 4 mounths ]
  9. Total cholesterol [ Time Frame: 4 mounths ]
  10. Low density lipoprotein cholesterol [ Time Frame: 4 mounths ]
  11. High density lipoprotein cholesterol [ Time Frame: 4 mounths ]
  12. Triglycerides [ Time Frame: 4 mounths ]
  13. hsCRP [ Time Frame: 4 mounths ]
  14. Alkaline phosphatase [ Time Frame: 4 mounths ]
  15. Aspartate enzyme aminotransferase [ Time Frame: 4 mounths ]
  16. Alanine enzyme aminotransferase [ Time Frame: 4 mounths ]
  17. GammaGT [ Time Frame: 4 mounths ]
  18. Glycemic curve [ Time Frame: 4 mounths ]
  19. Insulin curve [ Time Frame: 4 mounths ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032861


Locations
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Brazil
Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
Araraquara, Sao Paulo, Brazil, 14800-903
Sponsors and Collaborators
São Paulo State University
Investigators
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Principal Investigator: Thais B Cesar, PhD Sao Paulo State University
Additional Information:
Publications of Results:
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Responsible Party: Thais Cesar, PhD, São Paulo State University
ClinicalTrials.gov Identifier: NCT03032861    
Other Study ID Numbers: SaoPSU2
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.
Keywords provided by Thais Cesar, São Paulo State University:
Orange juice
Microbiota
Prebiotic
Flavanones
Bioavailability
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases