The Effect of 40gr Okara on Gastric Emptying

NCT ID: NCT01079585

Last Updated: 2010-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy People

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Interventions

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Nutrigal Okara - 100

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutrigal LTD

UNKNOWN

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Nachum Vaisman, Prof'

Role: CONTACT

009-972-3-6974807

Facility Contacts

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Nachum Vaisman

Role: primary

00-972-3-6974807

Other Identifiers

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TASMC-10-NV-014-CTIL

Identifier Type: -

Identifier Source: org_study_id

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