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GRAPE • Glycemic Response of Amylopectin Containing Drinks (GRAPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916692
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 7, 2020
Sponsor:
Collaborator:
Standard Process Inc.
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Glycemic Index Dietary Supplement: Carbohydrate drink Dietary Supplement: Energy smart Carbohydrate blend Dietary Supplement: Liquid Dextrose Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized Cross-over trial
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Glycemic Response of Amylopectin Containing Drinks
Actual Study Start Date : April 23, 2019
Actual Primary Completion Date : January 30, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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 Name: 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




Primary Outcome Measures :
  1. Area Under the Curve of Glucose [ Time Frame: 120 minutes ]
    Positive integer of the area under the Curve of glucose

  2. Area Under the Curve for Insulin [ Time Frame: 120 minutes ]
    Positive integer of the area under the Curve of insulin

  3. Blood glucose [ Time Frame: 30, 60 and 120 minutes of the glucose challenge ]
    Blood glucose levels

  4. Blood insulin [ Time Frame: 30, 60 and 120 minutes of the glucose challenge ]
    Blood insulin levels


Secondary Outcome Measures :
  1. c-peptide [ Time Frame: 30, 60, and 120 minutes of the glucose challenge ]
    Blood levels of c-peptide

  2. glucagon [ Time Frame: 30, 60, and 120 minutes of of the glucose challenge ]
    Blood levels of glucagon

  3. Leptin [ Time Frame: 30, 60, and 120 minutes of the glucose challenge ]
    Blood levels of leptin

  4. Adiponectin [ Time Frame: 30, 60, and 120 minutes of the glucose challenge ]
    Blood levels of adiponectin

  5. glucagon-like-peptide-1 [ Time Frame: 30, 60, and 120 minutes of the glucose challenge ]
    Blood levels of glucagon-like-peptide-1



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-reported
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916692


Contacts
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Contact: Stavros Kavouras, PhD 6028272265 stavros.kavouras@asu.edu
Contact: Adam Seal, MS ada.seal@asu.edu

Locations
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United States, Arizona
Arizona Biomedical Collaborative Recruiting
Phoenix, Arizona, United States, 85004
Contact: Stavros Kavouras, PhD    602-827-2265    stavros.kavouras@asu.edu   
Contact: Adam Seal, MS    (479) 531-6059    adam.seal@asu.edu   
Sponsors and Collaborators
Arizona State University
Standard Process Inc.
Investigators
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Principal Investigator: Stavros Kavouras, PhD Arizona State University
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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT03916692    
Other Study ID Numbers: FP00016578
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No