The Glycemic Effect of Taking a Supplementation of Orange Juice With Fibers

Healthy People Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00966862
• Other study ID #: TASMC-09-NV-237-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: May 2010

Study information

• Verified date: May 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 aim of this study is to investigate the glycemic effect of supplementation Fibers in orange juice.

This will be a double-blind parallel controlled study. Each subject will serve as his own control.

Study population will include 10 subjects. The subjects will be randomly assigned to receive one of two juices in occasion, in two visits. Each drink will be containing orange juice with\without fibers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 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,

• overweight,

• kidney failure,

• heart disease,

• osteoporosis.

• Antibiotic treatment in the last 4 weeks

• Subjects on regular probiotic or prebiotic supplementation, unless they do 2 weeks of wash out.

• 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

Study Design

N/A

Related Conditions & MeSH terms

• Healthy People

Intervention

Other:
• 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 investigate the Glycemic Effect by drawing blood for glucose and insulin