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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 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:
NCT00966784
First received: August 26, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Official Title: The Effect of 2 Months Daily Supplementation of Orange Juice With Fibers

Resource links provided by NLM:


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

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

Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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)
  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: NCT00966784

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

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00966784     History of Changes
Other Study ID Numbers: TASMC-09-NV-233-CTIL
Study First Received: August 26, 2009
Last Updated: August 26, 2009
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on July 23, 2014