Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults

Sponsor

General Mills (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05870891

Collaborator

INQUIS Clinical Research Ltd. (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to test the hypothesis that the equivalent glycemic load (EGL) value of portions of white bread containing 5 g available carbohydrate measured in this study is accurate and precise to within 1 gram. Additionally, the EGL of 7 low carbohydrate foods will be measured to determine their glycemic impact.

Condition or Disease	Intervention/Treatment	Phase
Healthy Nutrition	Other: Food	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peanut Butter Cereal Consumption of Peanut Butter Cereal	Other: Food Food
Experimental: Cinnamon Almond Cereal Consumption of Cinnamon Almond Cereal	Other: Food Food
Experimental: Sriracha Crisps Consumption of Sriracha Crisps	Other: Food Food
Experimental: Cheddar Crisps Consumption of Cheddar Crisps	Other: Food Food
Experimental: Almond Blueberry Butter Bar Consumption of Almond Blueberry Butter Bar	Other: Food Food
Experimental: Peanut Butter and Dark Chocolate Bar Consumption of Peanut Butter and Dark Chocolate Bar	Other: Food Food
Experimental: Almond Dark Chocolate Bar Consumption of Almond Dark Chocolate Bar	Other: Food Food
Experimental: White Bread 5 g available carbohydrate Consumption of white bread containing 5 g available carbohydrate	Other: Food Food
Active Comparator: White Bread 20 g available carbohydrate Consumption of white bread containing 20 g available carbohydrate	Other: Food Food

Outcome Measures

Primary Outcome Measures

Equivalent glycemic load [0-120 minutes]
The equivalent glycemic load of 9 foods will be measured by collecting blood samples for plasma glucose analysis (via finger-stick). Blood will be collected at 0, 15, 30, 45, 60, 90 and 120 minutes. Equivalent glycemic load is defined as the amount of available carbohydrate from white bread that elicits a glycemic response equivalent to that after 1 serving of the food.

Secondary Outcome Measures

Insulin response [0-120 min]
The insulin response of 9 foods will be measured by collecting blood samples for plasma insulin analysis (via finger-stick). Blood will be collected at 0, 15, 30, 45, 60, 90 and 120 minutes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults aged 18-75 inclusive
Willing to abstain from unusual strenuous exercise and consuming alcoholic drinks for 24 hours before study days
Willing to refrain from smoking tobacco or marijuana for 12h before and during study visits
Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator
Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP

Exclusion Criteria:

Failure to meet any one of the inclusion criteria at screening
Pregnant or lactating individuals
Personal history of diabetes
Major trauma or surgical event within 3 months of screening
The presence of any laboratory result, health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator
Unwillingness or inability to comply with experimental procedures and to follow INQUIS safety guidelines
Known intolerance, sensitivity, or allergy to any ingredients in the study test meals. All allergens should be assumed to be a result of manufacturing practices.
Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement or lifestyle modification

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

General Mills
INQUIS Clinical Research Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

General Mills

ClinicalTrials.gov Identifier:

NCT05870891

Other Study ID Numbers:

INQ-2324

First Posted:

May 23, 2023

Last Update Posted:

May 31, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 31, 2023