A Study to Evaluate Glucose and Insulin Response to Nutralin

January 11, 2011 updated by: Avera McKennan Hospital & University Health Center
The purpose of this study is to evaluate how an investigational food product affects a healthy person's blood sugar and insulin levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals in and around the area of Sioux Falls, SD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • No other names at this time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose blood level
Time Frame: 4 weeks
Measure the change in blood sugar levels
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosage of Insulin
Time Frame: 4 weeks
Measure the levels of insulin
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avera McKennan Hospital & University Health Center

Collaborators

Vintek, LLC

Investigators

  • Principal Investigator: Edward Zawada, MD, Avera McKennan Hospital & University Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

January 12, 2011

Last Update Submitted That Met QC Criteria

January 11, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARI-1330-Nutralin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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