The Satiety Effect After Okara Compared to Porridge Eating

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting

Sponsor:

Collaborator:

Nutrigal LTD

Information provided by:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT01075568

First received: February 17, 2010

Last updated: March 2, 2010

Last verified: February 2010

History of Changes

Purpose

To examine the satiety effect after eating of Okara.

Condition	Intervention
Healthy People	Dietary Supplement: Nutrigal Okara - 100


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

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


Estimated Enrollment:	10
Study Start Date:	March 2010
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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.

Eligibility


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


ClinicalTrials.gov Identifier:	NCT01075568 History of Changes
Other Study ID Numbers:	TASMC-10-NV-016-CTIL
Study First Received:	February 17, 2010
Last Updated:	March 2, 2010

ClinicalTrials.gov processed this record on August 21, 2017

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