GRAPE • Glycemic Response of Amylopectin Containing Drinks (GRAPE)

Glycemic Response of Amylopectin Containing Drinks

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.

Study Overview

• Status: Terminated
• Conditions: Glycemic Index
• Intervention / Treatment: Dietary supplement: Carbohydrate drink; Dietary supplement: Energy smart Carbohydrate blend; Dietary supplement: Liquid Dextrose

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona Biomedical Collaborative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Process - glucose balance; Standard Process - glucose balance formula (200 kcal)	Dietary supplement: Carbohydrate drink; Meal replacement drink containing 200 kcal; Other Names: SP-glucose balance formula
Experimental: Energy smart Carbohydrate blend; Energy smart carbohydrate blend (50 grams, 200 kcal)	Dietary supplement: Energy smart Carbohydrate blend; Carbohydrate blend drink designed for low glycemic responses containing 200 kcal
Active Comparator: Liquid Dextrose Control; Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 grams, 200 kcal)	Dietary supplement: Liquid Dextrose; Liquid Dextrose drink of 200 kcal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
c-peptide	Blood levels of c-peptide	30, 60, and 120 minutes of the glucose challenge
glucagon	Blood levels of glucagon	30, 60, and 120 minutes of of the glucose challenge
Leptin	Blood levels of leptin	30, 60, and 120 minutes of the glucose challenge
Adiponectin	Blood levels of adiponectin	30, 60, and 120 minutes of the glucose challenge
glucagon-like-peptide-1	Blood levels of glucagon-like-peptide-1	30, 60, and 120 minutes of the glucose challenge

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Standard Process Inc.
• Investigators: Principal Investigator: Stavros Kavouras, PhD, Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2019
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: FP00016578

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