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 terminated.
(Sponsor recalled the study)
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01275027
First received: January 10, 2011
Last updated: October 4, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Diabetes
Dietary Supplement: Nutralin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • Blood Sugar [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    blood sugar levels

  • HgA1c reduction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    reduction of Hemoglobin A1c levels


Secondary Outcome Measures:
  • Diabetes medication [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    reduction in the amount of diabetes medication needed


Enrollment: 0
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutralin
Individuals with Type 2 Diabetes
Dietary Supplement: Nutralin
7 capsules taken 15 minutes before each of the three main meals of the day
Placebo Comparator: Placebo
Individuals with Type 2 Diabetes
Dietary Supplement: Nutralin
7 capsules taken 15 minutes before each of the three main meals of the day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275027

Locations
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Edward Zawada, MD Avera McKennan Hospital & University Health Center
  More Information

Additional Information:
No publications provided

Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01275027     History of Changes
Other Study ID Numbers: ARI-1340-Nutralin
Study First Received: January 10, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
diabetes
blood sugar
insulin
nutritional supplement
nutraceutical

ClinicalTrials.gov processed this record on October 19, 2014