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The Satiety Effect After Okara Compared to Porridge Eating

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: NCT01075568
Recruitment Status : Unknown
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2010
Last Update Posted : March 3, 2010
Nutrigal LTD
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
To examine the satiety effect after eating of Okara.

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

Detailed Description:

This will be a single blind, cross-over design. Study population will include 10 subjects. The patients will be randomly assigned to receive one of two meals, 48 gram Okara or 40 gram (similar caloric value) semolina in two occasions (two visits). After the eating, the subject will stay in a closed room, without watch or any irritation. After three hours, the patient will fill a VAS questionnaire, and will get a standard meal. The meal will be weighed before and after.

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

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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 examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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): NCT01075568

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Contact: Nachum Vaisman, Prof' 009-972-3-6974807

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Tel Aviv Medical Center
Tel Aviv, Israel
Contact: Nachum Vaisman, Prof'    00-972-3-6974807   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Nutrigal LTD
Layout table for additonal information Identifier: NCT01075568    
Other Study ID Numbers: TASMC-10-NV-016-CTIL
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: February 2010