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A Study to Evaluate Glucose and Insulin Response to Nutralin

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ClinicalTrials.gov Identifier: NCT01275820
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : January 12, 2011
Sponsor:
Collaborator:
Vintek, LLC
Information provided by:
Avera McKennan Hospital & University Health Center

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

Condition or disease Intervention/treatment
Diabetes Dietary Supplement: Nutralin

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.

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Evaluate Glucose and Insulin Response to Nutralin
Study Start Date : June 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Glucose blood level [ Time Frame: 4 weeks ]
    Measure the change in blood sugar levels


Secondary Outcome Measures :
  1. Dosage of Insulin [ Time Frame: 4 weeks ]
    Measure the levels of insulin


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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

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): 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

Additional Information:
Responsible Party: Dave Kuper, RPh, Avera Research Institute
ClinicalTrials.gov Identifier: NCT01275820     History of Changes
Other Study ID Numbers: ARI-1330-Nutralin
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs