StarvationNCT02364661
The Influence of Short-term Starvation on Hepatitis B Virus Load
A study testing Over night starvation (fasting) in people with Starvation and Infection, run by Rabin Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Starvation, Infection
- What is being tested?
- Over night starvation (fasting)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatitis B virus patients with detectable viremia
- >18 years old
- signed a consent form
Who cannot join
- patients with malignancy
- Patients with diabetes mellitus
- Alcohol consumption of more than 140grams a week
- Advanced liver disease
- HCV or HIV infection
- Pregnancy
- Mental retardation or unable to understand basic explanation about the study -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of Short-term Starvation on Disease Severity and Viral Replication Among Hepatitis B Virus Patients
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.
- Conditions
- Starvation, Infection
- Being tested
- Over night starvation (fasting)
- Keywords
- Hepatitis B virus, Metabolovirus
- Medical subject headings
- Starvation, Infections, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over night starvation (fasting)Behavioural
HBV viral load will be analyzed after over-night starvation versus following a morning meal
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B virus infected patients | Experimental | HBV patients with detectable viremia will be analyzed for their level of viremia following an over-night starvation (fasting) versus fed state Receives: Behavioral: Over night starvation (fasting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states
Measured: Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over all).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StarvationStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR SHLOMAI, Rabin Medical Center
- Investigators
- Amir Shlomai, MD/PhD, Principal investigator, Rabin Medical Center, Beilinson hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364661
- Sponsor's protocol ID
- 0601-14-RMC
- Status last verified
- Feb 2015
- First submitted
- 5 Feb 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17043229Shlomai 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.
PubMed 18334285
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Short-term Starvation on Disease Severity and Viral Replication Among Hepatitis B Virus Patients
- ClinicalTrials.gov ID
- NCT02364661
- Acronym / sponsor ID
- 0601-14-RMC
- Conditions
- Starvation, Infection
- Keywords
- Hepatitis B virus, Metabolovirus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 18 Feb 2015 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B virus infected patients | Experimental | Behavioral: Over night starvation (fasting)HBV patients with detectable viremia will be analyzed for their level of viremia following an over-night starvation (fasting) versus fed state |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hepatitis B virus patients with detectable viremia
- >18 years old
- signed a consent form
Key exclusion criteria (7 listed)
- patients with malignancy
- Patients with diabetes mellitus
- Alcohol consumption of more than 140grams a week
- Advanced liver disease
- HCV or HIV infection
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 |
|---|---|---|
| Over night starvation (fasting)HBV viral load will be analyzed after over-night starvation versus following a morning meal | Behavioural | Hepatitis B virus infected patients |
Primary outcome
A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states
Time frame: Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over all).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Background: PubMed 17043229Shlomai 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.
- Background: PubMed 18334285Shlomai 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.
Related trials for Starvation
Active, not recruitingPhase 4
Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Critical Illness, Starvation
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.
Amir Shlomai, MD/PhD principal investigator
Rabin Medical Center, Beilinson hospital
Questions about this trial
What is this clinical trial studying?
A study testing Over night starvation (fasting) in people with Starvation and Infection, run by Rabin Medical Center.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Shlomai, MD/PhD (972-3-9377250, amirsh9@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states (time frame: Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over 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 NCT02364661, which also lists 2 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 18 Feb 2015.