A Study to Evaluate Glucose and Insulin Response to Nutralin

NCT ID: NCT01275820

Last Updated: 2011-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nutralin

All 10 subjects in the study will consume the investigational food product.

Nutralin

Intervention Type DIETARY_SUPPLEMENT

Food product to be taken 15 minutes prior to each of the three main meals of the day.

Interventions

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Nutralin

Food product to be taken 15 minutes prior to each of the three main meals of the day.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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No other names at this time.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vintek, LLC

UNKNOWN

Sponsor Role collaborator

Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role lead

Responsible Party

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Avera Research Institute

Principal Investigators

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Edward Zawada, MD

Role: PRINCIPAL_INVESTIGATOR

Avera McKennan Hospital & University Health Center

Locations

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Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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ARI-1330-Nutralin

Identifier Type: -

Identifier Source: org_study_id

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