Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

October 10, 2016 updated by: Nestlé

Plasma Glucose and Insulin Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus

This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-75 yrs
  • Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
  • Hemoglobin A1C less than 9.0%
  • Fasting blood glucose less than 180 mg

Exclusion Criteria:

  • Abnormal thyroid function
  • Creatinine >2.0 mg/dL
  • Potassium <3.5 mEq/L
  • Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
  • Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
  • Unable to give informed consent or follow instructions
  • Current insulin therapy or insulin therapy within the past month
  • Patients who are pregnant
  • Allergies to milk, soy or any component of the test product
  • Patient who in the Investigators assessment cannot be expected to comply with treatment
  • Currently participating or having participated in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Boost Glucose Control (A)
Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.
Other: Boost Glucose Control (A)
Oral nutrition supplement
EXPERIMENTAL: Boost Glucose Control (B)
Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.
Other: Boost Glucose Control (B)
Oral nutrition supplement
ACTIVE_COMPARATOR: Boost Original
Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption.
Other: Boost Original
Oral nutrition supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the blood glucose curve (AUC 0-240)
Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the insulin curves (AUC 0-240)
Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Insulinogenic index (Ins30/(Glu30)
Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
AUC (0-30min) for insulin
Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (ESTIMATE)

August 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15.11.US.HCN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be presented in a peer reviewed manuscript

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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