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

Healthy People Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00966784
• Other study ID #: TASMC-09-NV-233-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: August 26, 2009
• Last updated: August 26, 2009
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study

Related Conditions & MeSH terms

• Healthy People

Intervention

Other:
• Dietary Fibers

Locations

Country	Name	City	State
Israel	Suorasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the effect of 2 Months Daily Supplementation of Orange Juice with fibers on the weight and the plasma lipids