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

NCT ID: NCT00966784

Last Updated: 2009-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy People

Interventions

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Dietary Fibers

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Locations

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Suorasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TASMC-09-NV-233-CTIL

Identifier Type: -

Identifier Source: org_study_id