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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01275027
• Other study ID #: ARI-1340-Nutralin
• Status: Withdrawn
• Phase: Phase 2
• First received: January 10, 2011
• Last updated: April 21, 2015
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: April 2015
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Dietary Supplement:
• Nutralin
7 capsules taken 15 minutes before each of the three main meals of the day

Locations

Country	Name	City	State
United States	Avera Research Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Sugar	blood sugar levels	16 weeks	No
Primary	HgA1c reduction	reduction of Hemoglobin A1c levels	16 weeks	No
Secondary	Diabetes medication	reduction in the amount of diabetes medication needed	16 weeks	No

External Links

•   Avera Research Institute website