Glycemic Response to Wild Rice and Wild Rice Blends in Humans Study (EFGW)

Evaluating the Factors That Influence Glycemic Response to Wild Rice and Wild Rice Blends in Humans (EFGW) Study.

The goal of this clinical trial is to test the effects of wild rice and wild rice blends compared to other rice on glycemic control and evaluating factors that influence glycemic response to wild rice in healthy individuals. The main questions aim to answer:

1. Is there an effect of wild rice on blends on glycemic control and response?
2. Does cooking wild rice via stovetop or microwave change its glycemic response?
3. Is the wild rice blend product palatable?
4. What is the subjective appetite when consuming the treatment?

Participants will:

• consent to attend 5 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: Completed
• Conditions: Blood Glucose
• Intervention / Treatment: Other: 15% Wild rice and 85% Brown rice blend - Stovetop; Other: Whole wild rice; Other: Whole brown rice; Other: Whole white rice (control); Other: 15% Wild rice and 85% Brown rice blend - Microwaved

Detailed Description

This study will be a crossover randomized trial consisting of 5 sessions. The wild rice products will be provided by the Myera group.

Participants will fast and arrive at the Richardson Centre for Food Technology and Research (RCFTR) between 7am - 11am on the session day. They will be provided either of the study treatments 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. VAS will be completed following consumption of the treatments to measure palatability and subjective appetite at baseline (0 min), and at 15, 30, 45, 60, 90, and 120 minute time points.

The primary objective is to test the effects of wild rice and wild rice blends compared to other rice on glycemic control and 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. Secondly, to test whether wild rice glycemic response is affected based on cooking method.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • Richardson Center for Food Technology and Research

Participation Criteria

Eligibility Criteria

• 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)
• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Consumption of 1 of 3 rice products; This arm will provide 1 of the 3 randomly assigned rice products to the participant and there will be a minimum of three days separating each visit.	Other: 15% Wild rice and 85% Brown rice blend - Stovetop; One serving size (140g cooked on stovetop) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout.
Experimental: Consumption of 2 of 3 rice products; This arm will provide the consumption of the second randomly assigned rice product. There will be a minimum of three days separating each visit.	Other: Whole wild rice; One serving size (140g cooked on stovetop) of whole wild rice will be provided. Cooking time will be consistently maintained throughout.
Experimental: Consumption of 3 of 3 rice products; This arm will provide the third consumption of the randomly assigned rice product. There will be a minimum of three days separating each visit.	Other: Whole brown rice; One serving size (140g cooked on stovetop) of whole brown rice will be provided. Cooking time will be consistently maintained throughout.
Active Comparator: Consumption of the control rice product; This arm will provide the white rice control product.	Other: Whole white rice (control); One serving size (140g cooked on stovetop) of whole white rice will be provided. Cooking time will be consistently maintained throughout.
Experimental: Consumption of 1 of 3 rice products with different preparation method; This arm will provide the blends product via a different cooking method (microwave).	Other: 15% Wild rice and 85% Brown rice blend - Microwaved; One serving size (140g cooked in microwave) of 15% wild rice and 85% brown rice blend (Myera) will be provided. Cooking time will be consistently maintained throughout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic response	Finger stick blood glucose will be taken throughout each session.	Capillary blood glucose will be measured at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes after the treatment has been consumed..

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatability of rice products	Visual Analogue Scale (VAS) assessment following consumption of the treatment	VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes
Subjective appetite	Visual Analogue Scale (VAS) assessment following consumption of the treatment measurement.	VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes.

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Mitacs
• Investigators: Principal Investigator: Dylan MacKay, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: rice; glycemic control; glycemic response
• Other Study ID Numbers: HS25900 (B2023:033)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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