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

NCT05870891 | Completed

• 1 other identifier: INQ-2324
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Nutrition

Outcome Measures

Primary Outcomes (1)

• Equivalent glycemic load

  Equivalent glycemic load (EGL) for each test food, expressed as \[EGL = T/(W/Cwb)\] where T is the plasma glucose incremental area under the curve over 120 minutes (iAUC) elicited by one serving of test food, W is the mean iAUC elicited by the mean of two WB20 tests and Cwb is the amount of available carbohydrate in the WB20.

  -5 minutes to 120 minutes

Secondary Outcomes (2)

• Insulin iAUC over 120 minutes

  -5 minutes to 120 minutes

• Glucose iAUC over 120 minutes

  -5 minutes to 120 minutes

Study Arms (9)

Peanut Butter Cereal

EXPERIMENTAL

Consumption of Peanut Butter Cereal

Other: Food

Cinnamon Almond Cereal

EXPERIMENTAL

Consumption of Cinnamon Almond Cereal

Other: Food

Sriracha Crisps

EXPERIMENTAL

Consumption of Sriracha Crisps

Other: Food

Cheddar Crisps

EXPERIMENTAL

Consumption of Cheddar Crisps

Other: Food

Almond Blueberry Butter Bar

EXPERIMENTAL

Consumption of Almond Blueberry Butter Bar

Other: Food

Peanut Butter and Dark Chocolate Bar

EXPERIMENTAL

Consumption of Peanut Butter and Dark Chocolate Bar

Other: Food

Almond Dark Chocolate Bar

EXPERIMENTAL

Consumption of Almond Dark Chocolate Bar

Other: Food

White Bread 5 g available carbohydrate

EXPERIMENTAL

Consumption of white bread containing 5 g available carbohydrate

Other: Food

White Bread 20 g available carbohydrate

ACTIVE COMPARATOR

Consumption of white bread containing 20 g available carbohydrate

Other: Food

Interventions

Food OTHER

Food

Almond Blueberry Butter Bar; Almond Dark Chocolate Bar; Cheddar Crisps; Cinnamon Almond Cereal; Peanut Butter Cereal; Peanut Butter and Dark Chocolate Bar; Sriracha Crisps; White Bread 20 g available carbohydrate; White Bread 5 g available carbohydrate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Mills: lead
• INQUIS Clinical Research: collaborator

Study Sites (1)

INQUIS Clinical Research, Ltd.

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

• Wolever TM, Miller K, Banh T. Equivalent Glycemic Load and Insulinemic Responses Elicited by Low-Carbohydrate Foods: A Randomized Trial in Healthy Adults. Curr Dev Nutr. 2025 Oct 30;9(12):107594. doi: 10.1016/j.cdnut.2025.107594. eCollection 2025 Dec.

  PMID: 41439105 DERIVED

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 23, 2023
• Study Start: June 15, 2023
• Primary Completion: October 3, 2023
• Study Completion: October 27, 2023
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified participant data pertaining to glucose and insulin measurements will be available after publication and will be available until 3 years after the publication date.
• Access Criteria: Please contact the study sponsor to request access to the data.

Locations

CA (1)