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

Phase 2

Withdrawn

• Conditions: Diabetes
• Interventions: Dietary Supplement: Nutralin

• Registration Number: NCT01275027
• Lead Sponsor: Avera McKennan Hospital & University Health Center

Brief 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Nutralin	Individuals with Type 2 Diabetes
Nutralin	Nutralin	Individuals with Type 2 Diabetes

Primary Outcome Measures

Name	Time	Method
Blood Sugar	16 weeks	blood sugar levels
HgA1c reduction	16 weeks	reduction of Hemoglobin A1c levels

Secondary Outcome Measures

Name	Time	Method
Diabetes medication	16 weeks	reduction in the amount of diabetes medication needed

Trial Locations

Locations (1)

Avera Research Institute; 🇺🇸 Sioux Falls, South Dakota, United States