NCT01275027

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2 diabetes

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2011

Completed
9 days 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

January 10, 2011

Last Update Submit

April 21, 2015

Conditions

Diabetes

Keywords

diabetesblood sugarinsulinnutritional supplementnutraceutical

Outcome Measures

Primary Outcomes (2)

  • Blood Sugar

    blood sugar levels

    16 weeks

  • HgA1c reduction

    reduction of Hemoglobin A1c levels

    16 weeks

Secondary Outcomes (1)

  • Diabetes medication

    16 weeks

Study Arms (2)

Nutralin

EXPERIMENTAL

Individuals with Type 2 Diabetes

Dietary Supplement: Nutralin

Placebo

PLACEBO COMPARATOR

Individuals with Type 2 Diabetes

Dietary Supplement: Nutralin

Interventions

NutralinDIETARY_SUPPLEMENT

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

NutralinPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

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
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 12, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

US(1)