A Pilot Study Evaluating Oat Polyphenols on Post-prandial Glucose Response

NCT04260425 | Completed

• 1 other identifier: HS23437 (B2019:114)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The trial will use a two period acute double-blind cross-over design to compare the effects of a serving of oatmeal containing high or low amounts of avenanthramides (AV) on post-prandial blood glucose response in healthy adults.

Conditions

Blood Glucose

Outcome Measures

Primary Outcomes (1)

• post-prandial glucose response

  2 hour area under the curve of post-prandial glucose response to the interventions in mmol/L\*min\^2

  Area under the curve from 0,15, 30, 45, 60, 90 and 120 minutes

Study Arms (2)

High then low avenanthramides content oats

EXPERIMENTAL

This arm will receive the high avenanthramides content oatmeal at the first session and the low avenanthramides content oatmeal at the second session. Sessions will be at least 5 days apart.

Other: Serving of oatmeal made from low avenanthramides oats and water; Other: Serving of oatmeal made from high avenanthramides oats and water

Low then high avenanthramides content oats

EXPERIMENTAL

This arm will receive the low avenanthramides content oatmeal at the first session and the high avenanthramides content oatmeal at the second session. Sessions will be at least 5 days apart.

Other: Serving of oatmeal made from low avenanthramides oats and water; Other: Serving of oatmeal made from high avenanthramides oats and water

Interventions

Serving of oatmeal made from low avenanthramides oats and water OTHER

One serving size (40 grams dry weight) of low avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.

High then low avenanthramides content oats; Low then high avenanthramides content oats

Serving of oatmeal made from high avenanthramides oats and water OTHER

One serving size (40 grams dry weight) of high avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.

High then low avenanthramides content oats; Low then high avenanthramides content oats

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/m\^2
• Fasting glucose \<5.6 mmol/L
• Usually eat breakfast
• 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 consuming the study treatments within 10 minutes
• Use of medication or supplements that may influence carbohydrate metabolism, including, but not limited 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 oats
• Existing restrictive dietary habits (such a vegan, low carbohydrate or keto)
• Uncontrolled hypertension
• History of cancer within the last two years (except for non-melanoma skin cancer)
• Recent history of (within 12 month of screening) or current strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
• Body weight change over 3.5kg within 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 month

Sponsors & Collaborators

• University of Manitoba: lead
• Agriculture and Agri-Food Canada: collaborator

Study Sites (1)

Richardson Center for Food Technology and Research

Winnipeg, Manitoba, R3T 2E1, Canada

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Dylan Mackay, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: November 28, 2021
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

CA (1)