NCT03916692

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

April 23, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

2.4 years

First QC Date

April 12, 2019

Last Update Submit

September 7, 2022

Conditions

Glycemic Index

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • c-peptide

    30, 60, and 120 minutes of the glucose challenge

  • glucagon

    30, 60, and 120 minutes of of the glucose challenge

  • Leptin

    30, 60, and 120 minutes of the glucose challenge

  • Adiponectin

    30, 60, and 120 minutes of the glucose challenge

  • glucagon-like-peptide-1

    30, 60, and 120 minutes of the glucose challenge

Study Arms (3)

Standard Process - glucose balance

EXPERIMENTAL

Standard Process - glucose balance formula (200 kcal)

Dietary Supplement: Carbohydrate drink

Energy smart Carbohydrate blend

EXPERIMENTAL

Energy smart carbohydrate blend (50 grams, 200 kcal)

Dietary Supplement: Energy smart Carbohydrate blend

Liquid Dextrose Control

ACTIVE COMPARATOR

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

Dietary Supplement: Liquid Dextrose

Interventions

Carbohydrate drinkDIETARY_SUPPLEMENT

Meal replacement drink containing 200 kcal

Also known as: SP-glucose balance formula
Standard Process - glucose balance
Energy smart Carbohydrate blendDIETARY_SUPPLEMENT

Carbohydrate blend drink designed for low glycemic responses containing 200 kcal

Energy smart Carbohydrate blend
Liquid DextroseDIETARY_SUPPLEMENT

Liquid Dextrose drink of 200 kcal

Liquid Dextrose Control

Eligibility Criteria

Age30 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-reported
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 27.5 to 35 kg∙m-2

You may not qualify if:

  • Diagnosed diabetes
  • HbA1c \> 6.5
  • competitive athletes
  • body weigh change \> 3kg during last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

Location

Study Officials

  • Stavros Kavouras, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized Cross-over trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

April 23, 2019

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

September 8, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)