Clinical trial NCT05976633: Glycemic Response to Wild Rice and Wild Rice Blends in Humans Study
Official title: Evaluating the Factors That Influence Glycemic Response to Wild Rice and Wild Rice Blends in Humans (EFGW) Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Keywords: glycemic response
glycemic control
rice
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Mitacs
First posted: 2023-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: crossover randomized clinical trial.
Primary purpose: BASIC_SCIENCE

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:

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

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.

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)
* 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

Primary outcomes:
measure: Glycemic response
timeFrame: 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:
measure: Palatability of rice products
timeFrame: VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes
measure: Subjective appetite
timeFrame: VAS measurements at 0 (baseline) and then 15, 30, 45, 60, 90 and 120 minutes.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Center for Food Technology and Research
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Dylan MacKay, PHD
role: PRINCIPAL_INVESTIGATOR
References: