Study of a Carbohydrate Drink in Adults

Postprandial Gastric Emptying and Glycemic Response to a Pre-Operative Carbohydrate Drink in Adults With Pre-diabetes and Type II Diabetes Mellitus

The objective of this study is to determine the postprandial glycemic response and rates of gastric emptying in healthy subjects and those with pre-diabetes and type 2 diabetes following oral ingestion of carbohydrate.

Study Overview

• Status: Completed
• Conditions: Glycemic Response
• Intervention / Treatment: Other: Nutritional Supplement

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has voluntarily signed and dated an informed consent form and provided Health Insurance Portability and Accountability Act (HIPAA) authorization
• Subject is healthy or has pre-diabetes or type 2 diabetes
• Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum
• Subject's BMI is > 18.5 kg/m2 and ≤ 40.0 kg/m2
• If subject is on a chronic medication, the dosage has been constant
• Subject states willingness to follow protocol

Exclusion Criteria:

• Subject uses exogenous insulin or Glucagon-like peptide-1 (GLP-1) receptor agonists for glucose control
• Subject has type 1 diabetes
• Subject has a history of diabetic ketoacidosis
• Subject has current infection; has had in-patient surgery, or corticosteroid treatment or antibiotics
• Subject has an active malignancy
• Subject has had a significant cardiovascular event ≤ six months or history of congestive heart failure
• Subject has end-stage organ failure or is status post organ transplant.
• Subject has a history of renal disease
• Subject has current hepatic disease
• Subject has a history of severe gastroparesis
• Subject has a chronic, contagious, infectious disease
• Subject has taken/is currently taking any herbals, dietary supplements, or medications that could profoundly affect blood glucose
• Subject has clotting or bleeding disorders
• Subject is known to be allergic or intolerant to any ingredient found in the study products
• Subject is a participant in another study that has not been approved as a concomitant study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Supplement; Ready to drink liquid	Other: Nutritional Supplement; 50 g Carbohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Glucose Concentration	Area under the curve	Baseline 0 to 240 Minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Insulin Concentration	Area under the curve	Baseline 0 to 240 Minutes
Nutritional Product Assessment	Subject completed questionnaire with 2 product liking questions using 7-9 point Likert scale	Immediately following product consumption
Subjective Appetitive Ratings	Subject completed 4 visual analog scale statements scaled from Not at All to Extremely	Baseline 0 to 240 Minutes
Gastric Emptying	Rate of gastric emptying	Baseline 0 to 180 Minutes

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Bridget Cassady, PhD, RDN, LD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Actual): August 26, 2020
• Study Completion (Actual): August 26, 2020

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BL48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No