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Completed

NCT Number: NCT01275820

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutralin

Dietary Supplement

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.

Primary outcomes

  1. Glucose blood level

    Time frame: 4 weeks

    Measure the change in blood sugar levels

Secondary outcomes

  1. Dosage of Insulin

    Time frame: 4 weeks

    Measure the levels of insulin

Sponsors and collaborators

Lead sponsor

Avera McKennan Hospital & University Health Center

Other

Collaborators

  • Vintek, LLC

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 12, 2011
Registry last updated
Jan 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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