GRAPE • Glycemic Response of Amylopectin Containing Drinks

NCT ID: NCT03916692

Last Updated: 2022-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-23

Study Completion Date

2021-08-30

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)

Conditions

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Glycemic Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized Cross-over trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard Process - glucose balance

Standard Process - glucose balance formula (200 kcal)

Group Type EXPERIMENTAL

Carbohydrate drink

Intervention Type DIETARY_SUPPLEMENT

Meal replacement drink containing 200 kcal

Energy smart Carbohydrate blend

Energy smart carbohydrate blend (50 grams, 200 kcal)

Group Type EXPERIMENTAL

Energy smart Carbohydrate blend

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate blend drink designed for low glycemic responses containing 200 kcal

Liquid Dextrose Control

Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 grams, 200 kcal)

Group Type ACTIVE_COMPARATOR

Liquid Dextrose

Intervention Type DIETARY_SUPPLEMENT

Liquid Dextrose drink of 200 kcal

Interventions

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Carbohydrate drink

Meal replacement drink containing 200 kcal

Intervention Type DIETARY_SUPPLEMENT

Energy smart Carbohydrate blend

Carbohydrate blend drink designed for low glycemic responses containing 200 kcal

Intervention Type DIETARY_SUPPLEMENT

Liquid Dextrose

Liquid Dextrose drink of 200 kcal

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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SP-glucose balance formula

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Standard Process Inc.

INDUSTRY

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stavros Kavouras, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

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Arizona Biomedical Collaborative

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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FP00016578

Identifier Type: -

Identifier Source: org_study_id

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