GRAPE • Glycemic Response of Amylopectin Containing Drinks

Study Overview
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Brief Summary
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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
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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)

Official Title
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Glycemic Response of Amylopectin Containing Drinks

Conditions
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Glycemic Index

Intervention / Treatment
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* Dietary Supplement: Carbohydrate drink
* Dietary Supplement: Energy smart Carbohydrate blend
* Dietary Supplement: Liquid Dextrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized Cross-over trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |