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A Study to Evaluate Glucose and Insulin Response to Nutralin

This study has been completed.
Sponsor:
Collaborator:
Vintek, LLC
Information provided by:
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01275820
First received: January 10, 2011
Last updated: January 11, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.


Condition Intervention
Diabetes
 Dietary Supplement: Nutralin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Evaluate Glucose and Insulin Response to Nutralin

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Glucose blood level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measure the change in blood sugar levels


Secondary Outcome Measures:
  • Dosage of Insulin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measure the levels of insulin


Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 10
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nutralin
All 10 subjects in the study will consume the investigational food product.
 Dietary Supplement: Nutralin
Food product to be taken 15 minutes prior to each of the three main meals of the day.
Other Name: No other names at this time.

Detailed Description:

The investigational food 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 using the product. The hypothesis for this study is that healthy human subjects will have an increase in insulin levels after consuming the investigational food product.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals in and around the area of Sioux Falls, SD

Criteria

Inclusion Criteria:

  • Men and women who are at least 18 years of age
  • Non-diabetic

Exclusion Criteria:

  • Diabetes
  • Women who are pregnant, breastfeeding or planning to become pregnant
  • Current and active liver or kidney disease
  • Any food allergies
  • Celiac disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275820

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

Additional Information:
Avera Research Institute website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dave Kuper, RPh, Avera Research Institute
ClinicalTrials.gov Identifier: NCT01275820     History of Changes
Other Study ID Numbers: ARI-1330-Nutralin
Study First Received: January 10, 2011
Last Updated: January 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
diabetes, insulin, blood sugar

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 18, 2012