Clinical trial NCT03916692: GRAPE • Glycemic Response of Amylopectin Containing Drinks
Official title: Glycemic Response of Amylopectin Containing Drinks
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glycemic Index
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Standard Process Inc.
First posted: 2019-04-16
Enrollment: 15
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Cross-over trial
Primary purpose: BASIC_SCIENCE

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)

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Curve of Glucose
timeFrame: 120 minutes
measure: Area Under the Curve for Insulin
timeFrame: 120 minutes
measure: Blood glucose
timeFrame: 30, 60 and 120 minutes of the glucose challenge
measure: Blood insulin
timeFrame: 30, 60 and 120 minutes of the glucose challenge
Secondary outcomes:
measure: c-peptide
timeFrame: 30, 60, and 120 minutes of the glucose challenge
measure: glucagon
timeFrame: 30, 60, and 120 minutes of of the glucose challenge
measure: Leptin
timeFrame: 30, 60, and 120 minutes of the glucose challenge
measure: Adiponectin
timeFrame: 30, 60, and 120 minutes of the glucose challenge
measure: glucagon-like-peptide-1
timeFrame: 30, 60, and 120 minutes of the glucose challenge
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
affiliation: Arizona State University
name: Stavros Kavouras, PhD
role: PRINCIPAL_INVESTIGATOR
References: