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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Healthy People

Treatments: Other: Dietary Fibers

Study type: Interventional

Funder types: Other

Identifiers

NCT00966784

TASMC-09-NV-233-CTIL

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)