Healthy NutritionNCT05870891
Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults
A study testing Food in people with Healthy Nutrition, run by General Mills at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2023to 27 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodOther
Food
| Study group | Role | What they receive |
|---|---|---|
| Peanut Butter Cereal | Experimental | Consumption of Peanut Butter Cereal Receives: Other: Food |
| Cinnamon Almond Cereal | Experimental | Consumption of Cinnamon Almond Cereal Receives: Other: Food |
| Sriracha Crisps | Experimental | Consumption of Sriracha Crisps Receives: Other: Food |
| Cheddar Crisps | Experimental | Consumption of Cheddar Crisps Receives: Other: Food |
| Almond Blueberry Butter Bar | Experimental | Consumption of Almond Blueberry Butter Bar Receives: Other: Food |
| Peanut Butter and Dark Chocolate Bar | Experimental | Consumption of Peanut Butter and Dark Chocolate Bar Receives: Other: Food |
| Almond Dark Chocolate Bar | Experimental | Consumption of Almond Dark Chocolate Bar Receives: Other: Food |
| White Bread 5 g available carbohydrate | Experimental | Consumption of white bread containing 5 g available carbohydrate Receives: Other: Food |
| White Bread 20 g available carbohydrate | Active comparator | Consumption of white bread containing 20 g available carbohydrate Receives: Other: Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: -5 minutes to 120 minutes
Secondary outcomes (2)
Insulin iAUC over 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.
Measured: -5 minutes to 120 minutes
Glucose iAUC over 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.
Measured: -5 minutes to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start15 Jun 2023
- Primary completion3 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Mills
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870891
- Sponsor's protocol ID
- INQ-2324
- Status last verified
- Apr 2025
- First submitted
- 4 May 2023
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data pertaining to glucose and insulin measurements will be shared upon reasonable request.
Publications
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.
PubMed 41439105
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalent Glycemic Load and Insulinemic Response Elicited by 7 Low Carbohydrate Products in Healthy Adults
- ClinicalTrials.gov ID
- NCT05870891
- Acronym / sponsor ID
- INQ-2324
- Conditions
- Healthy Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- General MillsIndustry (pharma, biotech, devices)
- Collaborators
- INQUIS Clinical Research
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Peanut Butter Cereal | Experimental | Other: FoodConsumption of Peanut Butter Cereal |
| Cinnamon Almond Cereal | Experimental | Other: FoodConsumption of Cinnamon Almond Cereal |
| Sriracha Crisps | Experimental | Other: FoodConsumption of Sriracha Crisps |
| Cheddar Crisps | Experimental | Other: FoodConsumption of Cheddar Crisps |
| Almond Blueberry Butter Bar | Experimental | Other: FoodConsumption of Almond Blueberry Butter Bar |
| Peanut Butter and Dark Chocolate Bar | Experimental | Other: FoodConsumption of Peanut Butter and Dark Chocolate Bar |
| Almond Dark Chocolate Bar | Experimental | Other: FoodConsumption of Almond Dark Chocolate Bar |
| White Bread 5 g available carbohydrate | Experimental | Other: FoodConsumption of white bread containing 5 g available carbohydrate |
| White Bread 20 g available carbohydrate | Active comparator | Other: FoodConsumption of white bread containing 20 g available carbohydrate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoodFood | Other | 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 |
Primary outcome
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.
2 secondary outcomes
Insulin iAUC over 120 minutes
Time frame: -5 minutes to 120 minutes
Glucose iAUC over 120 minutes
Time frame: -5 minutes to 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Derived from this study: PubMed 41439105Wolever 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.
- Individual participant dataSharing planned: Yes. De-identified participant data pertaining to glucose and insulin measurements will be shared upon reasonable request.
Related trials for Healthy Nutrition
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food in people with Healthy Nutrition, run by General Mills at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalent glycemic load (time frame: -5 minutes to 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05870891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.