The Effect of 40gr Okara on Gastric Emptying

March 2, 2010 updated by: Tel-Aviv Sourasky Medical Center
The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This trail will be a single blinded, cross-over design. The study population will include 10 subjects. The patients will be randomly assigned to receive one of two Muffin cakes, with or without 40 grams Okara on three occasions (three visits). In two visits the subject will receive a Muffin cake with 40 grams Okara (but with similar caloric value), and in one visit a Muffin cake without Okara.

Postprandial gastric emptying time will be measured for each subject, by 13C Breath Test.

Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • Age 20-65 years old
  • Written Informed Consent

Exclusion Criteria:

  • History of gastro-intestinal surgery
  • On medication that may influence gastric emptying, or medication for weight loss
  • Patient on PPI treatment, H2 Blockers or medication for weight loss
  • Known allergies to soy
  • Pregnancy or breast-feeding
  • Smoking
  • Athletes
  • Metabolic syndrome or diabetes mellitus
  • Family history of metabolic syndrome or diabetes mellitus
  • Weight loss > 2 kg during two months before the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To investigate the influence of 40 gram Okara on gastric emptying

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Collaborators

Nutrigal LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ANTICIPATED)

October 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (ESTIMATE)

March 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 3, 2010

Last Update Submitted That Met QC Criteria

March 2, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • TASMC-10-NV-014-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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