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WithdrawnNCT01275027Updated Apr 22, 2015

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 Phase 2 interventional study of Nutralin in Diabetes, sponsored by Avera McKennan Hospital & University Health Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-22.

Sponsored by Avera McKennan Hospital & University Health Center · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Sponsor recalled the study
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Diabetes

Keywords

  • diabetes
  • blood sugar
  • insulin
  • nutritional supplement
  • nutraceutical
03

In context

Lead sponsor

Avera McKennan Hospital & University Health Center is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Nutralin

    Individuals with Type 2 Diabetes

    Dietary Supplement: Nutralin

  • Placebo comparator
    Placebo

    Individuals with Type 2 Diabetes

    Dietary Supplement: Nutralin

Interventions

  • Dietary supplementNutralin

    7 capsules taken 15 minutes before each of the three main meals of the day

06

What researchers measure

Primary outcomes

  1. Blood Sugar

    blood sugar levels

    Time frame: 16 weeks

  2. HgA1c reduction

    reduction of Hemoglobin A1c levels

    Time frame: 16 weeks

Secondary outcomes

  1. Diabetes medication

    reduction in the amount of diabetes medication needed

    Time frame: 16 weeks

07

Study locations

1 site
  • Avera Research Institute
    Sioux Falls, South Dakota 57105, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01275027
Lead sponsor
Avera McKennan Hospital & University Health Center
Responsible party
Sponsor
First posted
Jan 12, 2011
Start date
Jan 2011
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Apr 22, 2015

Study contacts

Edward Zawada, MD
principal investigator · Avera McKennan Hospital & University Health Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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