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A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin

A

Avera McKennan Hospital & University Health Center

Status and phase

Withdrawn
Phase 2

Conditions

Diabetes

Treatments

Dietary Supplement: Nutralin

Study type

Interventional

Funder types

Other

Identifiers

NCT01275027
ARI-1340-Nutralin

Details and patient eligibility

About

The purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.

Full description

The investigational 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 consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study.

The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men and women who are at least 18 years old
  • Diagnosis of Type 2 Diabetes
  • Has been on stable diabetes medication/insulin for the past three months

Exclusion criteria

  • Women who are pregnant, breastfeeding or planning to become pregnant
  • Diagnosis of Celiac Disease or gluten intolerance
  • Current or active kidney disease
  • Current or active liver disease
  • Any food allergies

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups, including a placebo group

Nutralin
Experimental group
Description:
Individuals with Type 2 Diabetes
Treatment:
Dietary Supplement: Nutralin
Placebo
Placebo Comparator group
Description:
Individuals with Type 2 Diabetes
Treatment:
Dietary Supplement: Nutralin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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