A Study to Evaluate Glucose and Insulin Response to Nutralin

Diabetes Clinical Trial

Official title:

A Study to Evaluate Glucose and Insulin Response to Nutralin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275820
• Other study ID #: ARI-1330-Nutralin
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: January 11, 2011
• Start date: June 2010
• Est. completion date: September 2010

Study information

• Verified date: January 2011
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Intervention

Dietary Supplement:
• Nutralin
Food product to be taken 15 minutes prior to each of the three main meals of the day.

Locations

Country	Name	City	State
United States	Avera Research Institute	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center	Vintek, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose blood level	Measure the change in blood sugar levels	4 weeks	No
Secondary	Dosage of Insulin	Measure the levels of insulin	4 weeks	No

External Links

•   Avera Research Institute website