NCT01275820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
Last Updated

January 12, 2011

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

January 10, 2011

Last Update Submit

January 11, 2011

Conditions

Diabetes

Keywords

diabetes, insulin, blood sugar

Outcome Measures

Primary Outcomes (1)

  • Glucose blood level

    Measure the change in blood sugar levels

    4 weeks

Secondary Outcomes (1)

  • Dosage of Insulin

    4 weeks

Study Arms (1)

Nutralin

All 10 subjects in the study will consume the investigational food product.

Dietary Supplement: Nutralin

Interventions

NutralinDIETARY_SUPPLEMENT

Food product to be taken 15 minutes prior to each of the three main meals of the day.

Also known as: No other names at this time.
Nutralin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals in and around the area of Sioux Falls, SD

You may qualify if:

  • Men and women who are at least 18 years of age
  • Non-diabetic

You may not qualify if:

  • Diabetes
  • Women who are pregnant, breastfeeding or planning to become pregnant
  • Current and active liver or kidney disease
  • Any food allergies
  • Celiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Edward Zawada, MD

    Avera McKennan Hospital & University Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 12, 2011

Study Start

June 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

January 12, 2011

Record last verified: 2011-01

Locations

US(1)