Glucose Response in Persons With Type 2 Diabetes

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT04914559

Collaborator

(none)

Enrollment

Location

Arms

1.4

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a randomized crossover design with oral nutrition supplement interventions.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Other: Oral nutrition supplement - control Other: Oral nutrition supplement - test	N/A

Detailed Description

This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.This will be a randomized crossover design. The subjects will be randomized to one of two interventions on two separate study days, one week apart.

Masking:

Single (Participant)

Masking Description:

Site pharmacy will not be blinded to product assignment, study staff and participants will be blinded to product assignment. Product will be provided in unlabeled cups.

Primary Purpose:

Supportive Care

Official Title:

Plasma Glucose and Insulin Response in Adults With Type 2 Diabetes Mellitus

Actual Study Start Date :

May 17, 2021

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral Nutrition Supplement Control The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition.	Other: Oral nutrition supplement - control Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
Active Comparator: Oral Nutrition Supplement Test The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes.	Other: Oral nutrition supplement - test Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.

Arm

Intervention/Treatment

Active Comparator: Oral Nutrition Supplement Control

The control study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition.

Other: Oral nutrition supplement - control

Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.

Active Comparator: Oral Nutrition Supplement Test

The test study intervention is an oral drink that contain protein, carbohydrate and fat and are intended for use as supplemental nutrition for people living with diabetes.

Other: Oral nutrition supplement - test

Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.

Outcome Measures

Primary Outcome Measures

Area under the blood glucose curve [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Area under the blood glucose curve (AUC 0-240 minutes)

Secondary Outcome Measures

Area under the insulin curve [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Area under the insulin curve (AUC 0-240 minutes)
Insulinogenic index [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Insulinogenic index (change in Ins30/change in Glu30)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 20-75 years
Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
Hemoglobin A1C less than 9.0%
Fasting blood glucose less than 180 mg/dl
Hematocrit levels within normal limits
Having obtained his/her informed consent

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
Patients with anemia
Current insulin therapy or insulin therapy within the past month
Patient 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
Patients with anemia
Currently participating in another clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orange County Research Center	Tustin	California	United States	92780

Sponsors and Collaborators

Nestlé

Investigators

Study Director: Krysmaru Araujo Torres, MD, Nestle Health Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT04914559

Other Study ID Numbers:

21.01.US.HCN

First Posted:

Jun 4, 2021

Last Update Posted:

Aug 17, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 17, 2021