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

August 26, 2009 updated by: Tel-Aviv Sourasky Medical Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Suorasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To investigate the Glycemic Effect by drawing blood for glucose and insulin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Nachum Vaisman, Prof', Suorasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

February 1, 2010

Study Completion

May 1, 2010

Study Registration Dates

First Submitted

August 26, 2009

First Submitted That Met QC Criteria

August 26, 2009

First Posted (ESTIMATE)

August 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 27, 2009

Last Update Submitted That Met QC Criteria

August 26, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • TASMC-09-NV-237-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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