Chronic InfectionNCT03026569
Orange Juice Consumption in Patients With Hepatitis C
A study testing Orange juice (500 mL/d) in people with Chronic Infection, run by São Paulo State University at 1 site in Brazil.
Trial summary
This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C, may contribute to the treatment of patients with chronic hepatitis C. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Infection
- What is being tested?
- Orange juice (500 mL/d)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Sep 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Detection of circulating HCV RNA
- Negative HBV surface antigen
- Negative antibodies to HIV
Who cannot join
- Co-infection with hepatitis B virus (HBV)
- Co-infection with hepatitis A virus (HAV)
- Co-infection with human immunodeficiency virus (HIV)
- Presence of diabetes mellitus,
- Presence of ascites
- Elevation in serum ferritin levels
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sao Paulo State University "Julio de Mesquita Filho"
Araraquara, São Paulo, 14800-903
About this study
Official title: Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy
This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C, may contribute to the treatment of patients with chronic hepatitis C.
Read the detailed description
Forty-three patients with chronic hepatitis C who were being treated with pegylated interferon combined with ribavirin, according to the Clinical Protocol and Therapeutic Guidelines for Viral Hepatitis C and Co-infections of the Brazilian Health Ministry were randomly divided into two parallel groups: (1) orange juice (n = 23), which were supplemented with orange juice (500 mL/d) for 8 weeks; (2) control group (n = 20) composed of patients that were not drinking orange juice regularly. The recruitment process began in February 2012, the intervention was carried out from May 2012 to July 2012, and the data analysis started in September 2012. The sample number took into account variances on total cholesterol with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Dourado et al., 2015). The minimum sample size should have 20 individuals per group (n = 40), considering an approximately 15% dropout rate. Primary and secondary endpoints were the reduction of total cholesterol and modification of biochemical markers, respectively. Kolmogorov Smirnov and Levene test assessed normality and homogeneity of data, respectively. Assessment of the data was performed in all participants on the first and last day of the experiment. All the parameters were compared between the juice group and the control group using General Linear Model of Repeated Measures Analysis. Differences in baseline patients' characteristics between the two groups were analyzed by One-way analysis of variance (ANOVA). The LSD signed rank post-test was used to assess significant changes in parameters after the start of treatment in each group, and the differences were considered statistically significant at p < 0.05.
- Conditions
- Chronic Infection
- Being tested
- Orange juice (500 mL/d)
- Keywords
- orange juice, chronic hepatitis C, biochemical markers, oxidative stress, nutritional status, antioxidants
- Medical subject headings
- Persistent Infection, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juice (500 mL/d)Other
The patients were instructed to drink orange juice in two daily portions during eight consecutive weeks. Patients from both groups were asked to maintain their usual lifestyle, diet, and physical activity, and they were checked weekly by the researcher's team. Assessments of anthropometric data, dietary intake, as well as blood sample collection for biochemical analysis were performed in all participants on the first and last day of the experiment.
| Study group | Role | What they receive |
|---|---|---|
| Orange juice | Experimental | Orange juice: twenty-three patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were supplemented with 100% commercial pasteurized orange juice (500 mL/d) during 8 weeks. Receives: Other: Orange juice (500 mL/d) |
| Control | No intervention | Control: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Measured: 8 weeks
Secondary outcomes (17)
Body mass
Measured: 8 weeks
Body mass index
Measured: 8 weeks
% body fat
Measured: 8 weeks
Waist circumference
Measured: 8 weeks
Glucose
Measured: 8 weeks
Insulin
Measured: 8 weeks
HOMA-IR
Measured: 8 weeks
LDL-C
Measured: 8 weeks
HDL-C
Measured: 8 weeks
Triglycerides
Measured: 8 weeks
CRP
Measured: 8 weeks
alkaline phosphatase
Measured: 8 weeks
AST
Measured: 8 weeks
ALT
Measured: 8 weeks
gamma-GT
Measured: 8 weeks
TBARS
Measured: 8 weeks
ABTS
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 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, Ph.D, Principal investigator, Sao Paulo State University "Julio de Mesquita Filho"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026569
- Sponsor's protocol ID
- SaoPSU11
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dourado GK, Cesar TB. Investigation of cytokines, oxidative stress, metabolic, and inflammatory biomarkers after orange juice consumption by normal and overweight subjects. Food Nutr Res. 2015 Oct 20;59:28147. doi: 10.3402/fnr.v59.28147. eCollection 2015.
PubMed 26490535
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy
- ClinicalTrials.gov ID
- NCT03026569
- Acronym / sponsor ID
- SaoPSU11
- Conditions
- Chronic Infection
- Keywords
- orange juice, chronic hepatitis C, biochemical markers, oxidative stress, nutritional status, antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 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 to verify whether orange juice, source of citrus flavonoids and vitamin C, may contribute to the treatment of patients with chronic hepatitis C.
Detailed description
Forty-three patients with chronic hepatitis C who were being treated with pegylated interferon combined with ribavirin, according to the Clinical Protocol and Therapeutic Guidelines for Viral Hepatitis C and Co-infections of the Brazilian Health Ministry were randomly divided into two parallel groups: (1) orange juice (n = 23), which were supplemented with orange juice (500 mL/d) for 8 weeks; (2) control group (n = 20) composed of patients that were not drinking orange juice regularly. The recruitment process began in February 2012, the intervention was carried out from May 2012 to July 2012, and the data analysis started in September 2012. The sample number took into account variances on total cholesterol with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Dourado et al., 2015). The minimum sample size should have 20 individuals per group (n = 40), considering an approximately 15% dropout rate. Primary and secondary endpoints were the reduction of total cholesterol and modification of biochemical markers, respectively. Kolmogorov Smirnov and Levene test assessed normality and homogeneity of data, respectively. Assessment of the data was performed in all participants on the first and last day of the experiment. All the parameters were compared between the juice group and the control group using General Linear Model of Repeated Measures Analysis. Differences in baseline patients' characteristics between the two groups were analyzed by One-way analysis of variance (ANOVA). The LSD signed rank post-test was used to assess significant changes in parameters after the start of treatment in each group, and the differences were considered statistically significant at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange juice | Experimental | Other: Orange juice (500 mL/d)Orange juice: twenty-three patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were supplemented with 100% commercial pasteurized orange juice (500 mL/d) during 8 weeks. |
| Control | No intervention | –Control: twenty patients with chronic hepatitis C under pegylated interferon combined with ribavirin treatment were monitored for consumption of orange juice during 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Detection of circulating HCV RNA
- Negative HBV surface antigen
- Negative antibodies to HIV
Key exclusion criteria (6 listed)
- Co-infection with hepatitis B virus (HBV)
- Co-infection with hepatitis A virus (HAV)
- Co-infection with human immunodeficiency virus (HIV)
- Presence of diabetes mellitus,
- Presence of ascites
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 juice (500 mL/d)The patients were instructed to drink orange juice in two daily portions during eight consecutive weeks. Patients from both groups were asked to maintain their usual lifestyle, diet, and physical activity, and they were checked weekly by the researcher's team. Assessments of anthropometric data, dietary intake, as well as blood sample collection for biochemical analysis were performed in all participants on the first and last day of the experiment. | Other | Orange juice |
Primary outcome
Total cholesterol
Time frame: 8 weeks
17 secondary outcomes
Body mass
Time frame: 8 weeks
Body mass index
Time frame: 8 weeks
% body fat
Time frame: 8 weeks
Waist circumference
Time frame: 8 weeks
Glucose
Time frame: 8 weeks
Insulin
Time frame: 8 weeks
HOMA-IR
Time frame: 8 weeks
LDL-C
Time frame: 8 weeks
HDL-C
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
CRP
Time frame: 8 weeks
alkaline phosphatase
Time frame: 8 weeks
AST
Time frame: 8 weeks
ALT
Time frame: 8 weeks
gamma-GT
Time frame: 8 weeks
TBARS
Time frame: 8 weeks
ABTS
Time frame: 8 weeks
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 23 Jan 2017.
- Background: PubMed 26490535Dourado GK, Cesar TB. Investigation of cytokines, oxidative stress, metabolic, and inflammatory biomarkers after orange juice consumption by normal and overweight subjects. Food Nutr Res. 2015 Oct 20;59:28147. doi: 10.3402/fnr.v59.28147. eCollection 2015.
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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, Ph.D principal investigator
Sao Paulo State University "Julio de Mesquita Filho"
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 (500 mL/d) in people with Chronic Infection, 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 3 inclusion and 6 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 23 Jan 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 cholesterol (time frame: 8 weeks). 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 NCT03026569, which also lists 1 linked publication.
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 23 Jan 2017.