GRAPE • Glycemic Response of Amylopectin Containing Drinks

Glycemic Index Clinical Trial

— GRAPE  

Official title:

Glycemic Response of Amylopectin Containing Drinks

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03916692
• Other study ID #: FP00016578
• Status: Terminated
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2022
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Glycemic Index

Intervention

Dietary Supplement:
• Carbohydrate drink
Meal replacement drink containing 200 kcal
• Energy smart Carbohydrate blend
Carbohydrate blend drink designed for low glycemic responses containing 200 kcal
• Liquid Dextrose
Liquid Dextrose drink of 200 kcal

Locations

Country	Name	City	State
United States	Arizona Biomedical Collaborative	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Standard Process Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve of Glucose	Positive integer of the area under the Curve of glucose	120 minutes
Primary	Area Under the Curve for Insulin	Positive integer of the area under the Curve of insulin	120 minutes
Primary	Blood glucose	Blood glucose levels	30, 60 and 120 minutes of the glucose challenge
Primary	Blood insulin	Blood insulin levels	30, 60 and 120 minutes of the glucose challenge
Secondary	c-peptide	Blood levels of c-peptide	30, 60, and 120 minutes of the glucose challenge
Secondary	glucagon	Blood levels of glucagon	30, 60, and 120 minutes of of the glucose challenge
Secondary	Leptin	Blood levels of leptin	30, 60, and 120 minutes of the glucose challenge
Secondary	Adiponectin	Blood levels of adiponectin	30, 60, and 120 minutes of the glucose challenge
Secondary	glucagon-like-peptide-1	Blood levels of glucagon-like-peptide-1	30, 60, and 120 minutes of the glucose challenge