Intestinal DiseasesNCT03032861
The Prebiotic Effect of Daily Intake of Orange Juice Affects the Bioavailability of Flavanones?
A study testing Orange juice in people with Intestinal Diseases, run by São Paulo State University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intestinal Diseases
- What is being tested?
- Orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women BMI 18.5 - 29.9 kg/m2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sao Paulo State University "Julio de Mesquita Filho", Faculdade de Ciências Farmacêuticas
Araraquara, São Paulo, 14800-903
About this study
Official title: Influence of the Prebiotic Effect of Orange Juice on the Bioavailability of Flavanones After Chronic Intake of Orange Juice.
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.
Read the 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.
- Conditions
- Intestinal Diseases
- Being tested
- Orange juice
- Keywords
- Orange juice, Microbiota, Prebiotic, Flavanones, Bioavailability
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Orange juice | Experimental | Ten women will consume 100% orange juice (300 mL/day) during 60 days. Receives: Other: Orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total counting of aerobic bacteria and facultative anaerobic bacteria
Measured: 4 months
Determination of butyric acid
Measured: 4 months
Determination of acetic acid
Measured: 4 months
Ammonium concentration
Measured: 4 mounths
Secondary outcomes (19)
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
Measured: 4 months
Body mass index
Measured: 4 months
Body lean mass
Measured: 4 months
Body fat mass
Measured: 4 months
% body fat
Measured: 4 months
Ratio waist/hip
Measured: 4 mounths
Glucose
Measured: 4 mounths
Insulin
Measured: 4 mounths
Total cholesterol
Measured: 4 mounths
Low density lipoprotein cholesterol
Measured: 4 mounths
High density lipoprotein cholesterol
Measured: 4 mounths
Triglycerides
Measured: 4 mounths
hsCRP
Measured: 4 mounths
Alkaline phosphatase
Measured: 4 mounths
Aspartate enzyme aminotransferase
Measured: 4 mounths
Alanine enzyme aminotransferase
Measured: 4 mounths
GammaGT
Measured: 4 mounths
Glycemic curve
Measured: 4 mounths
Insulin curve
Measured: 4 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Cesar, São Paulo State University
- Investigators
- Thais B Cesar, PhD, Principal investigator, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032861
- Sponsor's protocol ID
- SaoPSU2
- Status last verified
- Apr 2017
- First submitted
- 6 Jan 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.
Publications
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.
PubMed 25495754Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PubMed 11234459Kanaze 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.
PubMed 17047689
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Prebiotic Effect of Orange Juice on the Bioavailability of Flavanones After Chronic Intake of Orange Juice.
- ClinicalTrials.gov ID
- NCT03032861
- Acronym / sponsor ID
- SaoPSU2
- Conditions
- Intestinal Diseases
- Keywords
- Orange juice, Microbiota, Prebiotic, Flavanones, Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orange juice | Experimental | Other: Orange juiceTen women will consume 100% orange juice (300 mL/day) during 60 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women BMI 18.5 - 29.9 kg/m2.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juiceThirty 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. | Other | Orange juice |
Primary outcome
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
19 secondary outcomes
Bioavailability of hesperitin and naringenin 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Results publication: PubMed 25495754Silveira 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.
- Results publication: PubMed 11234459Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Results publication: PubMed 17047689Kanaze 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.
- An exploratory study on the influence of orange juice on gut microbiota using a dynamic colonic modelLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. There is still no decision regarding if the individual participant data (IPD) will be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thais B Cesar, PhD principal investigator
São Paulo State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice in people with Intestinal Diseases, run by São Paulo State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total counting of aerobic bacteria and facultative anaerobic bacteria (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032861, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.