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

Avera McKennan Hospital & University Health Center

Status and phase: Withdrawn; Phase 2

Conditions: Diabetes

Treatments: Dietary Supplement: Nutralin

Study type: Interventional

Funder types: Other

Identifiers

NCT01275027

ARI-1340-Nutralin

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Nutralin

Experimental group

Description:

Individuals with Type 2 Diabetes

Treatment:

Dietary Supplement: Nutralin

Placebo

Placebo Comparator group

Description:

Individuals with Type 2 Diabetes

Treatment:

Dietary Supplement: Nutralin