A Study to Evaluate Glucose and Insulin Response to Nutralin | NCT01275820

Studies
A Study to Evaluate Glucose and Insulin Response to Nutralin

NCT01275820

Sponsor

Avera McKennan Hospital & University Health Center

Status

Completed

Last Update Posted

Jan 12, 2011Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Diabetes

Interventions

Nutralin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Sep 2010Actual

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

Jan 11, 2011

Last Update Posted Date

Jan 12, 2011Estimated

Name	Class
Vintek, LLC	UNKNOWN

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

Detailed Description

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.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutralin		All 10 subjects in the study will consume the investigational food product.	Dietary Supplement: Nutralin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutralin	Dietary Supplement	Food product to be taken 15 minutes prior to each of the three main meals of the day.	Nutralin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose blood level	Measure the change in blood sugar levels	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Dosage of Insulin	Measure the levels of insulin	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

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

Individuals in and around the area of Sioux Falls, SD

Sampling Method

Non-Probability Sample

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

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D007333	Insulin Resistance

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided