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GRAPE • Glycemic Response of Amylopectin Containing Drinks (GRAPE)

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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

Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 7, 2020
Actual Study Start Date  ICMJE April 23, 2019
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Area Under the Curve of Glucose [ Time Frame: 120 minutes ]
    Positive integer of the area under the Curve of glucose
  • Area Under the Curve for Insulin [ Time Frame: 120 minutes ]
    Positive integer of the area under the Curve of insulin
  • Blood glucose [ Time Frame: 30, 60 and 120 minutes of the glucose challenge ]
    Blood glucose levels
  • Blood insulin [ Time Frame: 30, 60 and 120 minutes of the glucose challenge ]
    Blood insulin levels
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • Area Under the Curve of Glucose [ Time Frame: 120 min ]
    Positive integer of the area under the Curve of glucose
  • Area Under the Curve for Insulin [ Time Frame: 120 min ]
    Positive integer of the area under the Curve of insulin
  • Blood glucose [ Time Frame: 30, 60 and 120 min of OGTT ]
    Blood glucose levels
  • Blood insulin [ Time Frame: 30, 60 and 120 min of OGTT ]
    Blood insulin levels
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • c-peptide [ Time Frame: 30, 60, and 120 minutes of the glucose challenge ]
    Blood levels of c-peptide
  • glucagon [ Time Frame: 30, 60, and 120 minutes of of the glucose challenge ]
    Blood levels of glucagon
  • Leptin [ Time Frame: 30, 60, and 120 minutes of the glucose challenge ]
    Blood levels of leptin
  • Adiponectin [ Time Frame: 30, 60, and 120 minutes of the glucose challenge ]
    Blood levels of adiponectin
  • glucagon-like-peptide-1 [ Time Frame: 30, 60, and 120 minutes of the glucose challenge ]
    Blood levels of glucagon-like-peptide-1
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • c-peptide [ Time Frame: 30, 60, and 120 min of OGTT ]
    Blood levels of c-peptide
  • glucagon [ Time Frame: 30, 60, and 120 min of OGTT ]
    Blood levels of glucagon
  • Leptin [ Time Frame: 30, 60, and 120 min of OGTT ]
    Blood levels of leptin
  • Adiponectin [ Time Frame: 30, 60, and 120 min of OGTT ]
    Blood levels of adiponectin
  • glucagon-like-peptide-1 [ Time Frame: 30, 60, and 120 min of OGTT ]
    Blood levels of glucagon-like-peptide-1
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GRAPE • Glycemic Response of Amylopectin Containing Drinks
Official Title  ICMJE Glycemic Response of Amylopectin Containing Drinks
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized Cross-over trial
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Glycemic Index
Intervention  ICMJE
  • Dietary Supplement: Carbohydrate drink
    Meal replacement drink containing 200 kcal
    Other Name: SP-glucose balance formula
  • Dietary Supplement: Energy smart Carbohydrate blend
    Carbohydrate blend drink designed for low glycemic responses containing 200 kcal
  • Dietary Supplement: Liquid Dextrose
    Liquid Dextrose drink of 200 kcal
Study Arms  ICMJE
  • Experimental: Standard Process - glucose balance
    Standard Process - glucose balance formula (200 kcal)
    Intervention: Dietary Supplement: Carbohydrate drink
  • Experimental: Energy smart Carbohydrate blend
    Energy smart carbohydrate blend (50 grams, 200 kcal)
    Intervention: Dietary Supplement: Energy smart Carbohydrate blend
  • Active Comparator: Liquid Dextrose Control
    Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 grams, 200 kcal)
    Intervention: Dietary Supplement: Liquid Dextrose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2020
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: self-reported
Ages  ICMJE 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Stavros Kavouras, PhD 6028272265 stavros.kavouras@asu.edu
Contact: Adam Seal, MS ada.seal@asu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03916692
Other Study ID Numbers  ICMJE FP00016578
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE Standard Process Inc.
Investigators  ICMJE
Principal Investigator: Stavros Kavouras, PhD Arizona State University
PRS Account Arizona State University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP