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GRAPE • Glycemic Response of Amylopectin Containing Drinks

Glycemic Response of Amylopectin Containing Drinks

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03916692
Acronym
GRAPE
Enrollment
15
Registered
2019-04-16
Start date
2019-04-23
Completion date
2021-08-30
Last updated
2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycemic Index

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)

Interventions

DIETARY_SUPPLEMENTCarbohydrate drink

Meal replacement drink containing 200 kcal

DIETARY_SUPPLEMENTEnergy smart Carbohydrate blend

Carbohydrate blend drink designed for low glycemic responses containing 200 kcal

DIETARY_SUPPLEMENTLiquid Dextrose

Liquid Dextrose drink of 200 kcal

Sponsors

Standard Process Inc.
CollaboratorINDUSTRY
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Intervention model description

Randomized Cross-over trial

Eligibility

Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Curve of Glucose120 minutesPositive integer of the area under the Curve of glucose
Area Under the Curve for Insulin120 minutesPositive integer of the area under the Curve of insulin
Blood glucose30, 60 and 120 minutes of the glucose challengeBlood glucose levels
Blood insulin30, 60 and 120 minutes of the glucose challengeBlood insulin levels

Secondary

MeasureTime frameDescription
c-peptide30, 60, and 120 minutes of the glucose challengeBlood levels of c-peptide
glucagon-like-peptide-130, 60, and 120 minutes of the glucose challengeBlood levels of glucagon-like-peptide-1
glucagon30, 60, and 120 minutes of of the glucose challengeBlood levels of glucagon
Leptin30, 60, and 120 minutes of the glucose challengeBlood levels of leptin
Adiponectin30, 60, and 120 minutes of the glucose challengeBlood levels of adiponectin

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026