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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

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ClinicalTrials.gov Identifier: NCT01275027
Recruitment Status : Withdrawn (Sponsor recalled the study)
First Posted : January 12, 2011
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Nutralin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Blood Sugar [ Time Frame: 16 weeks ]
    blood sugar levels

  2. HgA1c reduction [ Time Frame: 16 weeks ]
    reduction of Hemoglobin A1c levels


Secondary Outcome Measures :
  1. Diabetes medication [ Time Frame: 16 weeks ]
    reduction in the amount of diabetes medication needed



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275027


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

Additional Information:
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Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01275027     History of Changes
Other Study ID Numbers: ARI-1340-Nutralin
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Avera McKennan Hospital & University Health Center:
diabetes
blood sugar
insulin
nutritional supplement
nutraceutical