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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05026424
Other study ID # 21.04.US.HCN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2, 2021
Est. completion date October 5, 2021

Study information

Verified date June 2021
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date October 5, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Balance oral nutritional drink - control
Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
Balance oral nutritional drink - 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.

Locations

Country Name City State
United States Orange County Research Center Tustin California

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-prandial glycemic markers Area under the blood glucose curve (AUC 0-240 minutes) [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Secondary Post-prandial insulin markers Area under the insulin curve (AUC 0-240 minutes) [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Secondary Insulinogenic index Insulinogenic index (change in Ins30/change in Glu30) [Time Frame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
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