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Completed

NCT Number: NCT03026569

Orange Juice Consumption in Patients With Hepatitis C

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.

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Key information

Conditions

Chronic Infection Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Infection RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sao Paulo State University "Julio de Mesquita Filho"

Araraquara, São Paulo, 14800-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Detection of circulating HCV RNA
  • Negative HBV surface antigen
  • Negative antibodies to HIV

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Total cholesterol

    Time frame: 8 weeks

Secondary outcomes

  1. Body mass

    Time frame: 8 weeks

  2. Body mass index

    Time frame: 8 weeks

  3. % body fat

    Time frame: 8 weeks

  4. Waist circumference

    Time frame: 8 weeks

  5. Glucose

    Time frame: 8 weeks

  6. Insulin

    Time frame: 8 weeks

  7. HOMA-IR

    Time frame: 8 weeks

  8. LDL-C

    Time frame: 8 weeks

  9. HDL-C

    Time frame: 8 weeks

  10. Triglycerides

    Time frame: 8 weeks

  11. CRP

    Time frame: 8 weeks

  12. alkaline phosphatase

    Time frame: 8 weeks

  13. AST

    Time frame: 8 weeks

  14. ALT

    Time frame: 8 weeks

  15. gamma-GT

    Time frame: 8 weeks

  16. TBARS

    Time frame: 8 weeks

  17. ABTS

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

São Paulo State University

Other

Registry information

Official study title

Orange Juice as Dietary Source of Antioxidants for Patients With Hepatitis C Under Antiviral Therapy

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 20, 2017
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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