Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Glycemic Effect of Taking a Supplementation of Orange Juice With Fibers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00966862
First received: August 26, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy People
Other: Other: Dietary Fibers
Phase 1
Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • To investigate the Glycemic Effect by drawing blood for glucose and insulin

Study Start Date: September 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with chronic disease sach as:

    • diabetes,
    • cancer,
    • C.O.P.D.,
    • metabolic syndrome,
    • overweight,
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966862

Locations
Israel
Suorasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Nachum Vaisman, Prof'    +972-3-6974807    vaisman@tasmc.health.gov.il   
Principal Investigator: Nachum Vaisman, Prof'         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nachum Vaisman, Prof' Suorasky Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00966862     History of Changes
Other Study ID Numbers: TASMC-09-NV-237-CTIL
Study First Received: August 26, 2009
Last Updated: August 26, 2009
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on November 25, 2014