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The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers

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ClinicalTrials.gov Identifier: NCT00966784
Recruitment Status : Unknown
Verified August 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 27, 2009
Last Update Posted : August 27, 2009
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:

The study hypothesis is that 2 Months Daily Supplementation of Orange juice with fibers will effect the weight and the plasma lipids.

This will be a double-blind parallel controlled study. Study population will include 50 subjects, who will be divided randomly into two groups. The first group will get the Orange juice with fibers, and the second group will get Orange juice with out the fibers.


Condition or disease Intervention/treatment Phase
Healthy People Other: Dietary Fibers Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Official Title: The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers
Study Start Date : September 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources




Primary Outcome Measures :
  1. To examine the effect of 2 Months Daily Supplementation of Orange Juice with fibers on the weight and the plasma lipids


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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,
    • over weight,
    • kidney failure,
    • heart disease and
    • osteoporosis.
  • Antibiotic treatment in the last 4 weeks
  • Subjects on regular probiotic or prebiotic supplementation, unless the subject will do 2 weeks of wash out before commencing the study.
  • 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
  • Subjects with abnormal base-line blood test results: liver functions and/or kidney functions, cholesterol level above 200 mg/dL and glucose level above 50 mg/dL (during fast)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966784


Locations
Israel
Suorasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00966784     History of Changes
Other Study ID Numbers: TASMC-09-NV-233-CTIL
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: August 27, 2009
Last Verified: August 2009