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

Launched by DYLAN MACKAY · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Blood Glucose Response of Novel Wild Rice Enhanced Food Products," is looking to see how new wild rice cereal products affect blood sugar levels compared to regular breakfast options. The study aims to understand if these wild rice products can help people manage their blood sugar better and if they taste good. If you are between 18 and 50 years old, have a healthy body weight, and usually eat breakfast, you might be eligible to participate.

Participants will need to attend six study visits, each lasting about 2.5 hours, and should arrive after fasting for at least 10-12 hours. During the visits, you will have your blood sugar measured and will fill out a short survey about your appetite. It's important to note that people with certain health conditions, like diabetes or significant dietary restrictions, may not be able to participate. Overall, this trial offers a chance to explore new food options that could be beneficial for managing blood sugar levels.

Gender

ALL

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