Healthy PeoplePhase 1/2NCT00966862
The Glycemic Effect of Taking a Supplementation of Orange Juice With Fibers
A Phase 1/2 study testing Other: Dietary Fibers in people with Healthy People, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to investigate the glycemic effect of supplementation Fibers in orange juice. This will be a double-blind parallel controlled study. Each subject will serve as his own control. Study population will include 10 subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- What is being tested?
- Other: Dietary Fibers
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to May 2010
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers
- Age 60 >18 years
- Written informed consent
- Consumers of orange drinks: freshly squeezed juices, commercial pasteurized juices and / or orange soft drinks
- Regular eating pattern
Who cannot join
- Patients with chronic disease sach as:
- diabetes,
- cancer,
- C.O.P.D.,
- metabolic syndrome,
- overweight,
Show all 15Show fewer
- kidney failure,
- heart disease,
- osteoporosis.
- Antibiotic treatment in the last 4 weeks
- Subjects on regular probiotic or prebiotic supplementation, unless they do 2 weeks of wash out.
- Subjects with intestinal disorders such as: IBD, IBS, celiac, colon cancer.
- Subjects after intestinal surgery.
- Use of medicines for lowering cholesterol (simvastatin), sugar control
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Suorasky Medical Center
Tel Aviv
Nachum Vaisman, Prof', +972-3-6974807, vaisman@tasmc.health.gov.il
Nachum Vaisman, Prof'
About this study
The aim of this study is to investigate the glycemic effect of supplementation Fibers in orange juice.
This will be a double-blind parallel controlled study. Each subject will serve as his own control.
Study population will include 10 subjects. The subjects will be randomly assigned to receive one of two juices in occasion, in two visits. Each drink will be containing orange juice with\without fibers.
- Conditions
- Healthy People
- Being tested
- Other: Dietary Fibers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Dietary FibersOther
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the Glycemic Effect by drawing blood for glucose and insulin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2010 (estimated)
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 1/2
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Nachum Vaisman, Prof', Principal investigator, Suorasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966862
- Sponsor's protocol ID
- TASMC-09-NV-237-CTIL
- Status last verified
- May 2009
- First submitted
- 26 Aug 2009
- Last updated
- 27 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Glycemic Effect of Taking a Supplementation of Orange Juice With Fibers
- ClinicalTrials.gov ID
- NCT00966862
- Acronym / sponsor ID
- TASMC-09-NV-237-CTIL
- Conditions
- Healthy People
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- May 2010
- First posted
- 27 Aug 2009 (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.
The aim of this study is to investigate the glycemic effect of supplementation Fibers in orange juice.
This will be a double-blind parallel controlled study. Each subject will serve as his own control.
Study population will include 10 subjects. The subjects will be randomly assigned to receive one of two juices in occasion, in two visits. Each drink will be containing orange juice with\without fibers.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Volunteers
- Age 60 >18 years
- Written informed consent
- Consumers of orange drinks: freshly squeezed juices, commercial pasteurized juices and / or orange soft drinks
- Regular eating pattern
Key exclusion criteria (15 listed)
- Patients with chronic disease sach as:
- Antibiotic treatment in the last 4 weeks
- Subjects on regular probiotic or prebiotic supplementation, unless they do 2 weeks of wash out.
- Subjects with intestinal disorders such as: IBD, IBS, celiac, colon cancer.
- Subjects after intestinal surgery.
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 |
|---|---|---|
| Other: Dietary Fibers | Other | – |
Primary outcome
To investigate the Glycemic Effect by drawing blood for glucose and insulin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2009.
Related trials for Healthy People
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingObservational study
Collection of Peripheral Blood Mononuclear Cells (PBMCs) From Healthy People for the Expansion of T Cells for Adoptive Cell Therapy
Healthy Volunteer
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.
Nachum Vaisman, Prof' principal investigator
Suorasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Other: Dietary Fibers in people with Healthy People, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 inclusion and 15 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 27 Aug 2009. 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 Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the Glycemic Effect by drawing blood for glucose and insulin. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2009.