COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

The Effect of 40gr Okara on Gastric Emptying

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Nutrigal LTD
Information provided by:
Tel-Aviv Sourasky Medical Center

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

Condition or disease Intervention/treatment Phase
Healthy People Dietary Supplement: Nutrigal Okara - 100 Not Applicable

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.

Layout table for study information
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

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 identifier (NCT number): NCT01079585

Layout table for location contacts
Contact: Nachum Vaisman, Prof' 009-972-3-6974807

Layout table for location information
Tel Aviv Medical Center
Tel Aviv, Israel
Contact: Nachum Vaisman    00-972-3-6974807   
Principal Investigator: Nachum Vaisman, Prof'         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Nutrigal LTD
Layout table for additonal information Identifier: NCT01079585    
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