NCT00966784

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 27, 2009

Status Verified

August 1, 2009

Enrollment Period

1 year

First QC Date

August 26, 2009

Last Update Submit

August 26, 2009

Conditions

Healthy People

Outcome Measures

Primary Outcomes (1)

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

Interventions

Dietary FibersOTHER

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suorasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

August 27, 2009

Record last verified: 2009-08

Locations

IL(1)