NCT01275027

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Avera McKennan Hospital & University Health Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutralin	7 capsules taken 15 minutes before each of the three main meals of the day

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-01-12
• Last updated: 2015-04-22

Locations

1 site across 1 country: United States