A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin

Study Overview
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Brief Summary
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The purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.

Detailed Description
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The investigational product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study. 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.

Official Title
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A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin

Conditions
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Diabetes

Intervention / Treatment
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* Dietary Supplement: Nutralin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women who are at least 18 years old Diagnosis of Type 2 Diabetes Has been on stable diabetes medication/insulin for the past three months Exclusion Criteria: Women who are pregnant, breastfeeding or planning to become pregnant Diagnosis of Celiac Disease or gluten intolerance Current or active kidney disease Current or active liver disease Any food allergies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutralin<br>Individuals with Type 2 Diabetes | Dietary Supplement: Nutralin<br>* 7 capsules taken 15 minutes before each of the three main meals of the day<br>|
| Placebo Comparator: Placebo<br>Individuals with Type 2 Diabetes | Dietary Supplement: Nutralin<br>* 7 capsules taken 15 minutes before each of the three main meals of the day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Sugar | blood sugar levels | 16 weeks | 
| HgA1c reduction | reduction of Hemoglobin A1c levels | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes medication | reduction in the amount of diabetes medication needed | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, blood sugar, insulin, nutritional supplement, nutraceutical