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

This study has been withdrawn prior to enrollment.
(Sponsor recalled the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01275027
First Posted: January 12, 2011
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
January 10, 2011
January 12, 2011
April 22, 2015
January 2011
August 2011   (Final data collection date for primary outcome measure)
  • Blood Sugar [ Time Frame: 16 weeks ]
    blood sugar levels
  • HgA1c reduction [ Time Frame: 16 weeks ]
    reduction of Hemoglobin A1c levels
Same as current
Complete list of historical versions of study NCT01275027 on ClinicalTrials.gov Archive Site
Diabetes medication [ Time Frame: 16 weeks ]
reduction in the amount of diabetes medication needed
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes
Dietary Supplement: Nutralin
7 capsules taken 15 minutes before each of the three main meals of the day
  • Experimental: Nutralin
    Individuals with Type 2 Diabetes
    Intervention: Dietary Supplement: Nutralin
  • Placebo Comparator: Placebo
    Individuals with Type 2 Diabetes
    Intervention: Dietary Supplement: Nutralin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01275027
ARI-1340-Nutralin
Yes
Not Provided
Not Provided
Avera McKennan Hospital & University Health Center
Avera McKennan Hospital & University Health Center
Not Provided
Principal Investigator: Edward Zawada, MD Avera McKennan Hospital & University Health Center
Avera McKennan Hospital & University Health Center
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP