The Satiety Effect After Okara Compared to Porridge Eating

• ClinicalTrials.gov Identifier: NCT01075568
• Recruitment Status: Unknown
• First Posted: February 25, 2010
• Last Update Posted: March 3, 2010
• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborator: Nutrigal LTD
• Information provided by: Tel-Aviv Sourasky Medical Center

Tracking Information

• First Submitted Date: February 17, 2010
• First Posted Date: February 25, 2010
• Last Update Posted Date: March 3, 2010
• Study Start Date: March 2010
• Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 24, 2010): To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Satiety Effect After Okara Compared to Porridge Eating
• Official Title: Not Provided
• Brief Summary: To examine the satiety effect after eating of Okara.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single
• Condition: Healthy People
• Intervention: Dietary Supplement: Nutrigal Okara - 100
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 24, 2010): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2010
• Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT01075568
• Other Study ID Numbers: TASMC-10-NV-016-CTIL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Nutrigal LTD
• Investigators: Not Provided
• PRS Account: Tel-Aviv Sourasky Medical Center
• Verification Date: February 2010