Glycemic Response to Wild Rice and Wild Rice Blends in Humans Study

NCT05976633 | Completed

• 1 other identifier: HS25900 (B2023:033)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Conditions

Blood Glucose

Keywords

glycemic response; glycemic control; rice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Palatability of rice products

  VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes

• Subjective appetite

  VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes.

Study Arms (5)

Consumption of 1 of 3 rice products

EXPERIMENTAL

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

Consumption of 2 of 3 rice products

EXPERIMENTAL

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

Consumption of 3 of 3 rice products

EXPERIMENTAL

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

Consumption of the control rice product

ACTIVE COMPARATOR

This arm will provide the white rice control product.

Other: Whole white rice (control)

Consumption of 1 of 3 rice products with different preparation method

EXPERIMENTAL

This arm will provide the blends product via a different cooking method (microwave).

Other: 15% Wild rice and 85% Brown rice blend - Microwaved

Interventions

Whole white rice (control) OTHER

One serving size (140g cooked on stovetop) of whole white rice will be provided. Cooking time will be consistently maintained throughout.

Consumption of the control rice product

Whole brown rice OTHER

One serving size (140g cooked on stovetop) of whole brown rice will be provided. Cooking time will be consistently maintained throughout.

Consumption of 3 of 3 rice products

Whole wild rice OTHER

One serving size (140g cooked on stovetop) of whole wild rice will be provided. Cooking time will be consistently maintained throughout.

Consumption of 2 of 3 rice products

15% Wild rice and 85% Brown rice blend - Stovetop OTHER

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.

Consumption of 1 of 3 rice products

15% Wild rice and 85% Brown rice blend - Microwaved OTHER

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.

Consumption of 1 of 3 rice products with different preparation method

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Mitacs: collaborator

Study Sites (1)

Richardson Center for Food Technology and Research

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Study Officials

• Dylan MacKay, PHD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: crossover randomized clinical trial.

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 4, 2023
• Study Start: July 14, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)