NCT00966862

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1

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

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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
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 27, 2009

Status Verified

May 1, 2009

Enrollment Period

5 months

First QC Date

August 26, 2009

Last Update Submit

August 26, 2009

Conditions

Healthy People

Outcome Measures

Primary Outcomes (1)

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

Interventions

Other: Dietary FibersOTHER

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suorasky Medical Center

Tel Aviv, Israel

Location

Study Officials

  • Nachum Vaisman, Prof'

    Suorasky Medical Center

    PRINCIPAL INVESTIGATOR

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

February 1, 2010

Study Completion

May 1, 2010

Last Updated

August 27, 2009

Record last verified: 2009-05

Locations

IL(1)