GRAPE • Glycemic Response of Amylopectin Containing Drinks

Not Applicable

Terminated

• Conditions: Glycemic Index
• Interventions: Dietary Supplement: Energy smart Carbohydrate blend; Dietary Supplement: Carbohydrate drink; Dietary Supplement: Liquid Dextrose

• Registration Number: NCT03916692
• Lead Sponsor: Arizona State University

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 Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-04-23
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Energy smart Carbohydrate blend	Energy smart Carbohydrate blend	Energy smart carbohydrate blend (50 grams, 200 kcal)
Standard Process - glucose balance	Carbohydrate drink	Standard Process - glucose balance formula (200 kcal)
Liquid Dextrose Control	Liquid Dextrose	Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 grams, 200 kcal)

Primary Outcome Measures

Name	Time	Method
Area Under the Curve of Glucose	120 minutes	Positive integer of the area under the Curve of glucose
Blood insulin	30, 60 and 120 minutes of the glucose challenge	Blood insulin levels
Area Under the Curve for Insulin	120 minutes	Positive integer of the area under the Curve of insulin
Blood glucose	30, 60 and 120 minutes of the glucose challenge	Blood glucose levels

Secondary Outcome Measures

Name	Time	Method
glucagon	30, 60, and 120 minutes of of the glucose challenge	Blood levels of glucagon
glucagon-like-peptide-1	30, 60, and 120 minutes of the glucose challenge	Blood levels of glucagon-like-peptide-1
Leptin	30, 60, and 120 minutes of the glucose challenge	Blood levels of leptin
Adiponectin	30, 60, and 120 minutes of the glucose challenge	Blood levels of adiponectin
c-peptide	30, 60, and 120 minutes of the glucose challenge	Blood levels of c-peptide

Trial Locations

Locations (1)

Arizona Biomedical Collaborative; 🇺🇸 Phoenix, Arizona, United States