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

January 10, 2011
January 11, 2011
June 2010
August 2010   (final data collection date for primary outcome measure)
Glucose blood level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Measure the change in blood sugar levels
Same as current
Complete list of historical versions of study NCT01275820 on ClinicalTrials.gov Archive Site
Dosage of Insulin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Measure the levels of insulin
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Glucose and Insulin Response to Nutralin
A Study to Evaluate Glucose and Insulin Response to Nutralin

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum

Non-Probability Sample

Individuals in and around the area of Sioux Falls, SD

Diabetes
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.
Nutralin
All 10 subjects in the study will consume the investigational food product.
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.
 
Completed
10
September 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01275820
ARI-1330-Nutralin
Yes
Dave Kuper, RPh, Avera Research Institute
Avera McKennan Hospital & University Health Center
Vintek, LLC
Principal Investigator: Edward Zawada, MD Avera McKennan Hospital & University Health Center
Avera McKennan Hospital & University Health Center
January 2011

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