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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy People
• Intervention / Treatment: Other: Dietary Fibers

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Suorasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• 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,
  • 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To examine the effect of 2 Months Daily Supplementation of Orange Juice with fibers on the weight and the plasma lipids

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): December 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: August 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: TASMC-09-NV-233-CTIL