The Effect of 40gr Okara on Gastric Emptying

The recruitment status of this study is unknown because the information has not been verified recently.
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:
NCT01079585
First received: February 17, 2010
Last updated: March 2, 2010
Last verified: February 2010
  Purpose

The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)


Condition Intervention
Healthy People
Dietary Supplement: Nutrigal Okara - 100

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

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

Primary Outcome Measures:
  • To investigate the influence of 40 gram Okara on gastric emptying [ Designated as safety issue: No ]

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 trail will be a single blinded, cross-over design. The study population will include 10 subjects. The patients will be randomly assigned to receive one of two Muffin cakes, with or without 40 grams Okara on three occasions (three visits). In two visits the subject will receive a Muffin cake with 40 grams Okara (but with similar caloric value), and in one visit a Muffin cake without Okara.

Postprandial gastric emptying time will be measured for each subject, by 13C Breath Test.

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
Genders Eligible for Study:   Both
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: NCT01079585

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    00-972-3-6974807    vaisman@tasmc.health.gov.il   
Principal Investigator: Nachum Vaisman, Prof'         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Nutrigal LTD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01079585     History of Changes
Other Study ID Numbers: TASMC-10-NV-014-CTIL
Study First Received: February 17, 2010
Last Updated: March 2, 2010
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on August 18, 2014