A Placebo-Controlled, Randomized, Safety and Efficacy Stu... | NCT01275027

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor recalled the study

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jan 10, 2011

First Submission Date that Met QC Criteria

Jan 11, 2011

First Posted Date

Jan 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2015

Last Update Posted Date

Apr 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutralin	Experimental	Individuals with Type 2 Diabetes	Dietary Supplement: Nutralin
Placebo	Placebo Comparator	Individuals with Type 2 Diabetes	Dietary Supplement: Nutralin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutralin	Dietary Supplement	7 capsules taken 15 minutes before each of the three main meals of the day	Nutralin Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Sugar	blood sugar levels	16 weeks
HgA1c reduction	reduction of Hemoglobin A1c levels	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Diabetes medication	reduction in the amount of diabetes medication needed	16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward Zawada, MD	Avera McKennan Hospital & University Health Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avera Research Institute		Sioux Falls	South Dakota	57105	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D003920	Diabetes Mellitus
D007333	Insulin Resistance

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D006946	Hyperinsulinism