The Satiety Effect After Okara Compared to Porridge Eating

Healthy People Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01075568
• Other study ID #: TASMC-10-NV-016-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 17, 2010
• Last updated: March 2, 2010
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, Prof'
• Phone: 009-972-3-6974807
• Email: vaisman[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To examine the satiety effect after eating of Okara.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Healthy People

Intervention

Dietary Supplement:
• Nutrigal Okara - 100

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Nutrigal LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.			No