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

NCT ID: NCT06498024

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

Brief Summary

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

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.

Conditions

Blood Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Kellogg's - rice krispies (control)

Intervention Type: OTHER

One serving size (140g) of whole white rice cereal will be provided. Preparation will be consistently maintained throughout.

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.

Group Type: ACTIVE_COMPARATOR

Kellogg's - rice krispies (control) + 125ml milk

Intervention Type: OTHER

One serving size (140g) of whole white rice cereal with 125ml of milk will be provided. Preparation will be consistently maintained throughout.

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.

Group Type: EXPERIMENTAL

Novel cereal (40% Canadian wild rice, 60% fava bean blend) + 125 ml milk

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Novel cereal (40% Canadian wild rice, 60% fava bean blend)

Intervention Type: OTHER

One serving size (140g) of novel cereal (40% Canadian wild rice, 60% fava bean blend) will be provided. Preparation will be consistently maintained throughout.

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.

Group Type: EXPERIMENTAL

Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato)

Intervention Type: OTHER

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.

Final consumption of 1 of 4 rice products

This arm will provide 1 of the 4 randomly assigned rice products to the participant.

Group Type: EXPERIMENTAL

Novel cereal (40% Canadian wild rice, 50% fava bean blend) + 10% purple powder (sweet potato) + 125 ml milk

Intervention Type: OTHER

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.

Interventions

Kellogg's - rice krispies (control)

One serving size (140g) of whole white rice cereal will be provided. Preparation will be consistently maintained throughout.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mitacs

INDUSTRY

Sponsor Role: collaborator

Dylan MacKay

OTHER

Sponsor Role: lead

Responsible Party

Dylan MacKay

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dylan MacKay, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Chronic Disease Innovation Centre, Seven Oaks Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

HS25756 (B2022:104) (Trial 2)

Identifier Type: -

Identifier Source: org_study_id