Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-01-25 @ 4:03 AM
Study NCT ID:
NCT02364661
Status:
UNKNOWN
Last Update Posted:
2015-02-18
First Post:
2015-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Short-term Starvation on Hepatitis B Virus Load
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013217', 'term': 'Starvation'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states', 'timeFrame': 'Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over all).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis B virus', 'Metabolovirus'], 'conditions': ['Starvation', 'Infection']}, 'referencesModule': {'references': [{'pmid': '17043229', 'type': 'BACKGROUND', 'citation': 'Shlomai A, Paran N, Shaul Y. PGC-1alpha controls hepatitis B virus through nutritional signals. Proc Natl Acad Sci U S A. 2006 Oct 24;103(43):16003-8. doi: 10.1073/pnas.0607837103. Epub 2006 Oct 16.'}, {'pmid': '18334285', 'type': 'BACKGROUND', 'citation': 'Shlomai A, Shaul Y. The "metabolovirus" model of hepatitis B virus suggests nutritional therapy as an effective anti-viral weapon. Med Hypotheses. 2008;71(1):53-7. doi: 10.1016/j.mehy.2007.08.032. Epub 2008 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus infects the liver and previous studies, done in tissue culture and in animals, have shown that viral replication is affected by metabolic changes occurring in the liver. Specifically, starvation induces HBV gene expression and replication, in parallel to the activation of the gluconeogenesis response, and feeding attenuates viral activity. In this study we are going to recruit HBV patients with detectable viremia and analyze their viral load after an over night starvation versus after a morning meal. Our hypothesis is that following an over-night starvation viral load will be higher than that in the fed state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hepatitis B virus patients with detectable viremia\n* \\>18 years old\n* signed a consent form\n\nExclusion Criteria:\n\n* patients with malignancy\n* Patients with diabetes mellitus\n* Alcohol consumption of more than 140grams a week\n* Advanced liver disease\n* HCV or HIV infection\n* Pregnancy\n* Mental retardation or unable to understand basic explanation about the study -'}, 'identificationModule': {'nctId': 'NCT02364661', 'briefTitle': 'The Influence of Short-term Starvation on Hepatitis B Virus Load', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Influence of Short-term Starvation on Disease Severity and Viral Replication Among Hepatitis B Virus Patients', 'orgStudyIdInfo': {'id': '0601-14-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hepatitis B virus infected patients', 'description': 'HBV patients with detectable viremia will be analyzed for their level of viremia following an over-night starvation (fasting) versus fed state', 'interventionNames': ['Behavioral: Over night starvation (fasting)']}], 'interventions': [{'name': 'Over night starvation (fasting)', 'type': 'BEHAVIORAL', 'description': 'HBV viral load will be analyzed after over-night starvation versus following a morning meal', 'armGroupLabels': ['Hepatitis B virus infected patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amir Shlomai, MD/PhD', 'role': 'CONTACT', 'email': 'amirsh9@clalit.org.il', 'phone': '972-3-9377250'}, {'name': 'Shulamit Greenstein, PhD', 'role': 'CONTACT', 'email': 'ShulamithG@clalit.org.il', 'phone': '972-3-9377250'}], 'overallOfficials': [{'name': 'Amir Shlomai, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rabin Medical Center, Beilinson hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'AMIR SHLOMAI', 'investigatorAffiliation': 'Rabin Medical Center'}}}}