Blood Glucose Response of Novel Wild Rice Enhanced Food Products (Trial 2) (ABWE)

August 18, 2025 updated by: Dylan MacKay

Assessing the Blood Glucose Response of Novel Wild Rice Enhanced Food Products (ABWE) Study

The goal of this acute double-blind cross over trial to test the effects of different wild rice cereal products compared to products currently on the market on glycaemic control. The main questions it aims to answer are:

  1. What is the effect compared to products currently on the market on glycaemic control?
  2. Is the wild rice product palatable?

Participants will:

  • consent to attend 6 study visits being 2.5 hours each
  • come to each visit fasted for at least 10-12 hours.
  • complete a Motivation to Eat VAS following each blood measure

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will consist of 2 acute double-blind cross-over trials and both trials investigate types of wild rice products tested against a white rice or white bread control. This is the second of the two trials and will be assessing four wild rice cereals against two control rice cereals.

Participants will fast and arrive at the RCFTR between 8 and 10:30 am on the session day. They will be provided either of the study treatment based on randomization sequence. Baseline blood glucose (0 min) will be measured twice via finger stick blood sample right before their first bite of the study product, and at 15, 30, 45, 60, 90 and 120 mins after baseline in duplicate. The timer will be started when they take their first bite. VAS will be completed following consumption of the treatments to measure palatability.

The primary objective is to test the effects of different wild rice products compared to products currently on the market by evaluating factors that influence glycemic response to wild rice in humans, performed via the finger stick blood glucose that will be measured throughout each session as outlined above.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 3M3
        • Chronic Disease Innovation Centre, Seven Oaks Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the trial
  • Male or female between 18-50 years old
  • BMI range in between 18.9-29.9 kg/m2
  • Fasting glucose <5.6 mmol/L
  • Usually eat breakfast
  • Participant must receive at least two doses of COVID-19 vaccine that have been recognized by Winnipeg Regional Health Authorities.
  • In the Investigator's opinion is able and willing to comply with all trial requirements

Exclusion Criteria:

  • Fasting glucose ≥ 5.6 mmol/L or <3.5 mmol/L
  • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
  • Participants who indicate that they could not finish study treatments within 10 minutes
  • Use of medication or supplements that may influence carbohydrate metabolism, including, not limit to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of screening visit
  • History of disordered eating, AIDS, hepatitis, a history of clinically important endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including but not limit to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders
  • Intolerance or allergic reaction to rice
  • Existing restrictive dietary habits (such a vegan, low carbohydrate/keto) Date and version No: December 12 , 2022, Version 2 Page 7 of 15
  • History of hypertension
  • History of cancer within the last two years (except for non-melanoma skin cancer)
  • Recent history (within 12 month of screening) or current consumption of >14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
  • Body weight change over 3.5kg for the past 3 months
  • Participants who have participated in another research trial involving an investigational product in the past 12 weeks
  • Had significant physical trauma or major surgery in the past 3 month or had trauma or major surgery in the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Consumption of 1 of 2 control rice cereal products
This arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit.
Other: Kellogg's - rice krispies (control)
One serving size (140g) of whole white rice cereal will be provided. Preparation will be consistently maintained throughout.
Active Comparator: Final consumption of 1 of 2 control rice cereal products
This arm will provide one of the 2 white rice control products and there will be a minimum of three days separating each visit.
Other: Kellogg's - rice krispies (control) + 125ml milk
One serving size (140g) of whole white rice cereal with 125ml of milk will be provided. Preparation will be consistently maintained throughout.
Experimental: Consumption of 1 of 4 rice products
This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.
Other: Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk
One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) with 125ml of milk will be provided. Preparation will be consistently maintained throughout.
Experimental: Second consumption of 1 of 4 rice products
This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.
Other: Novel cereal (40% Canadian wild rice, 60% fava bean blend)
One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) will be provided. Preparation will be consistently maintained throughout.
Experimental: Third consumption of 1 of 4 rice products
This arm will provide 1 of the 4 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.
Other: Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato)
One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) with a 10% added purple powder (sweet potato) will be provided. Preparation will be consistently maintained throughout.
Experimental: Final consumption of 1 of 4 rice products
This arm will provide 1 of the 4 randomly assigned rice products to the participant.
Other: Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) + 125 ml milk
One serving size (140g) of novel cereal (40% Canadian wild rice, 50% fava bean blend) and 10% purple powder (sweet potato) with 125 ml milk. Preparation will be consistently maintained throughout.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The effects of different wild rice products compared to products currently on the market on glycaemic control.
Time Frame: Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 mins after the first bite of treatment.
Finger stick blood glucose will be measured throughout each session.
Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 mins after the first bite of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To measure the palatability of the wild rice products following consumption.
Time Frame: VAS measuring palatability will be completed right after the consumption of the treatments.
Visual Analogue Scale (VAS).
VAS measuring palatability will be completed right after the consumption of the treatments.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dylan MacKay

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mitacs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dylan MacKay, PhD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS25756 (B2022:104) (Trial 2)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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