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

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Boost Glucose Control (A)
Boost Glucose Control (B)
Boost Original
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Orange County Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Boost Glucose Control (A)

Boost Glucose Control (B)

Boost Original

Arm Description

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.

Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption.

Outcomes

Primary Outcome Measures

Area under the blood glucose curve (AUC 0-240)

Secondary Outcome Measures

Area under the insulin curves (AUC 0-240)
Insulinogenic index (Ins30/(Glu30)
AUC (0-30min) for insulin

Full Information

First Posted
August 2, 2016
Last Updated
October 10, 2016
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02856516
Brief Title
Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Official Title
Plasma Glucose and Insulin Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boost Glucose Control (A)
Arm Type
Experimental
Arm Description
Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.
Arm Title
Boost Glucose Control (B)
Arm Type
Experimental
Arm Description
Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption in people with Diabetes.
Arm Title
Boost Original
Arm Type
Active Comparator
Arm Description
Nutritional beverage (Oral Nutrition Supplement) designed for oral consumption.
Intervention Type
Other
Intervention Name(s)
Boost Glucose Control (A)
Intervention Description
Oral nutrition supplement
Intervention Type
Other
Intervention Name(s)
Boost Glucose Control (B)
Intervention Description
Oral nutrition supplement
Intervention Type
Other
Intervention Name(s)
Boost Original
Intervention Description
Oral nutrition supplement
Primary Outcome Measure Information:
Title
Area under the blood glucose curve (AUC 0-240)
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary Outcome Measure Information:
Title
Area under the insulin curves (AUC 0-240)
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Title
Insulinogenic index (Ins30/(Glu30)
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Title
AUC (0-30min) for insulin
Time Frame
Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Neutel, MD
Organizational Affiliation
Orange County Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be presented in a peer reviewed manuscript

Learn more about this trial

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

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