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The Satiety Effect After Okara Compared to Porridge Eating

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Nutrigal LTD
Information provided by:
Tel-Aviv Sourasky Medical Center

Study Description
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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.


Study Design
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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
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01075568


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, Prof'    00-972-3-6974807    vaisman@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Nutrigal LTD
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT01075568     History of Changes
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