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Clinical Trials/NCT03916692
NCT03916692TerminatedNot Applicable

Glycemic Response of Amylopectin Containing Drinks

Arizona State University1 site in 1 country15 target enrollmentStarted: April 23, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
15
Locations
1
Primary Endpoint
Area Under the Curve of Glucose

Study Overview

Brief Summary

To quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.

The aim of the study is to quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.

Detailed Description

Subjects: 9 non-diabetic (HbA1c < 6.5) males aged 30-55 years with body mass indices ranging from 27.5 to 35 kg∙m-2. Individuals with impaired glucose tolerance will be included as long as they are not diagnosed with diabetes and their HbA1c is less than 6.5.

Preliminary Testing: Medical history, weight, height, body composition via dual x-ray absorptiometry (DXA) and glycosylated hemoglobin (HbA1c) measurement.

Protocol: After a 10-hour overnight fast, subjects will complete 3 experimental visits in which they will ingest one of three beverages in a randomized order. During experimental visits subjects will either be given the following 3 experimental drinks:

  • Full SP-glucose balance formula (200 kcal)
  • Energy smart carbohydrate blend (50 g, 200 kcal)
  • Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 g, 200 kcal)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
30 Years to 55 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •BMI 27.5 to 35 kg∙m-2

Exclusion Criteria

  • •Diagnosed diabetes
  • •HbA1c > 6.5
  • •competitive athletes
  • •body weigh change > 3kg during last month

Arms & Interventions

Standard Process - glucose balance

Experimental

Standard Process - glucose balance formula (200 kcal)

Intervention: Carbohydrate drink (Dietary Supplement)

Energy smart Carbohydrate blend

Experimental

Energy smart carbohydrate blend (50 grams, 200 kcal)

Intervention: Energy smart Carbohydrate blend (Dietary Supplement)

Liquid Dextrose Control

Active Comparator

Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 grams, 200 kcal)

Intervention: Liquid Dextrose (Dietary Supplement)

Outcomes

Primary Outcomes

Area Under the Curve of Glucose

Time Frame: 120 minutes

Positive integer of the area under the Curve of glucose

Blood insulin

Time Frame: 30, 60 and 120 minutes of the glucose challenge

Blood insulin levels

Area Under the Curve for Insulin

Time Frame: 120 minutes

Positive integer of the area under the Curve of insulin

Blood glucose

Time Frame: 30, 60 and 120 minutes of the glucose challenge

Blood glucose levels

Secondary Outcomes

  • glucagon(30, 60, and 120 minutes of of the glucose challenge)
  • glucagon-like-peptide-1(30, 60, and 120 minutes of the glucose challenge)
  • Leptin(30, 60, and 120 minutes of the glucose challenge)
  • Adiponectin(30, 60, and 120 minutes of the glucose challenge)
  • c-peptide(30, 60, and 120 minutes of the glucose challenge)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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