Study of a Carbohydrate Drink in Adults

NCT04313920 | Completed

• 1 other identifier: BL48
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Glycemic Response

Outcome Measures

Primary Outcomes (1)

• Plasma Glucose Concentration

  Area under the curve

  Baseline 0 to 240 Minutes

Secondary Outcomes (4)

• Serum Insulin Concentration

  Baseline 0 to 240 Minutes

• Nutritional Product Assessment

  Immediately following product consumption

• Subjective Appetitive Ratings

  Baseline 0 to 240 Minutes

• Gastric Emptying

  Baseline 0 to 180 Minutes

Study Arms (1)

Nutritional Supplement

EXPERIMENTAL

Ready to drink liquid

Other: Nutritional Supplement

Interventions

Nutritional Supplement OTHER

50 g Carbohydrate

Nutritional Supplement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (3)

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Biofortis

Addison, Illinois, 60101, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bridget Cassady, PhD, RDN, LD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 18, 2020
• Study Start: April 7, 2020
• Primary Completion: August 26, 2020
• Study Completion: August 26, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)