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OpenTrials
Completed

NCT Number: NCT05870891

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INQUIS Clinical Research, Ltd.

Toronto, Ontario, M5C 2N8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food

Other

Food

Primary outcomes

  1. Equivalent glycemic load

    Time frame: -5 minutes to 120 minutes

    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.

Secondary outcomes

  1. Insulin iAUC over 120 minutes

    Time frame: -5 minutes to 120 minutes

    Postprandial serum insulin incremental area under the curve over 120 minutes for each food in a subset of n=10 individuals. Blood will be collected at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.

  2. Glucose iAUC over 120 minutes

    Time frame: -5 minutes to 120 minutes

    Postprandial plasma glucose incremental area under the curve over 120 minutes for each food in n=25 individuals. Blood will be collected at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.

Sponsors and collaborators

Lead sponsor

General Mills

Industry

Collaborators

  • INQUIS Clinical Research

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 23, 2023
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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