Study of a Carbohydrate Drink in Adults

NCT ID: NCT04313920

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-07

Study Completion Date

2020-08-26

Brief Summary

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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.

Detailed Description

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Conditions

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Glycemic Response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nutritional Supplement

Ready to drink liquid

Group Type EXPERIMENTAL

Nutritional Supplement

Intervention Type OTHER

50 g Carbohydrate

Interventions

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Nutritional Supplement

50 g Carbohydrate

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bridget Cassady, PhD, RDN, LD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Health Awareness, Inc.

Jupiter, Florida, United States

Site Status

Biofortis

Addison, Illinois, United States

Site Status

Great Lakes Clinical Trials

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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BL48

Identifier Type: -

Identifier Source: org_study_id

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