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The Effect of 40gr Okara on Gastric Emptying

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ClinicalTrials.gov Identifier: NCT01079585
Recruitment Status : Unknown
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 3, 2010
Last Update Posted : March 3, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)

Condition or disease Intervention/treatment
Healthy People Dietary Supplement: Nutrigal Okara - 100

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Study Start Date : March 2010
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To investigate the influence of 40 gram Okara on gastric emptying

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079585


Contacts
Contact: Nachum Vaisman, Prof' 009-972-3-6974807 vaisman@tasmc.health.gov.il

Locations
Israel
Tel Aviv Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Nachum Vaisman    00-972-3-6974807    vaisman@tasmc.health.gov.il   
Principal Investigator: Nachum Vaisman, Prof'         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Nutrigal LTD
More Information

ClinicalTrials.gov Identifier: NCT01079585     History of Changes
Other Study ID Numbers: TASMC-10-NV-014-CTIL
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: February 2010