A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
NCT ID: NCT01275027
Last Updated: 2015-04-22
Study Results
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2011-01-31
2011-08-31
Brief Summary
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Detailed Description
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The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nutralin
Individuals with Type 2 Diabetes
Nutralin
7 capsules taken 15 minutes before each of the three main meals of the day
Placebo
Individuals with Type 2 Diabetes
Nutralin
7 capsules taken 15 minutes before each of the three main meals of the day
Interventions
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Nutralin
7 capsules taken 15 minutes before each of the three main meals of the day
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Type 2 Diabetes
* Has been on stable diabetes medication/insulin for the past three months
Exclusion Criteria
* Diagnosis of Celiac Disease or gluten intolerance
* Current or active kidney disease
* Current or active liver disease
* Any food allergies
18 Years
ALL
No
Sponsors
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Avera McKennan Hospital & University Health Center
OTHER
Responsible Party
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Principal Investigators
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Edward Zawada, MD
Role: PRINCIPAL_INVESTIGATOR
Avera McKennan Hospital & University Health Center
Locations
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Avera Research Institute
Sioux Falls, South Dakota, United States
Countries
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Other Identifiers
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ARI-1340-Nutralin
Identifier Type: -
Identifier Source: org_study_id
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