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

General Mills

Status: Completed

Conditions: Healthy Nutrition

Treatments: Other: Food

Study type: Interventional

Funder types: Industry

Identifiers

NCT05870891

INQ-2324

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 9 patient groups

Peanut Butter Cereal

Experimental group

Description:

Consumption of Peanut Butter Cereal

Treatment:

Other: Food

Cinnamon Almond Cereal

Experimental group

Description:

Consumption of Cinnamon Almond Cereal

Treatment:

Other: Food

Sriracha Crisps

Experimental group

Description:

Consumption of Sriracha Crisps

Treatment:

Other: Food

Cheddar Crisps

Experimental group

Description:

Consumption of Cheddar Crisps

Treatment:

Other: Food

Almond Blueberry Butter Bar

Experimental group

Description:

Consumption of Almond Blueberry Butter Bar

Treatment:

Other: Food

Peanut Butter and Dark Chocolate Bar

Experimental group

Description:

Consumption of Peanut Butter and Dark Chocolate Bar

Treatment:

Other: Food

Almond Dark Chocolate Bar

Experimental group

Description:

Consumption of Almond Dark Chocolate Bar

Treatment:

Other: Food

White Bread 5 g available carbohydrate

Experimental group

Description:

Consumption of white bread containing 5 g available carbohydrate

Treatment:

Other: Food

White Bread 20 g available carbohydrate

Active Comparator group

Description:

Consumption of white bread containing 20 g available carbohydrate

Treatment:

Other: Food