Effects of Barley on Glucose Control

January 31, 2024 updated by: Dr. Heather Blewett, St. Boniface Hospital

A Dose-response, Double-blind, Randomized, Controlled, Cross-over Trial Examining the Effect of Barley Beta-glucan on Post-prandial Glucose Response in Healthy Adults

Lifestyle modifications that include a diet high in fibre may lower the risk of developing type 2 diabetes (CDA, 2013). In this context, the presence of soluble dietary fibre in carbohydrate rich foods has been widely recognized for its effect on post-prandial glucose response (PPGR). Among these, oat and barley derived β-glucan have received tremendous attention for their biological effects, including their ability to reduce PPGR in a wide variety of food matrices (Poppitt et al, 2007). A health claim for PPGR would increase market demand for food grade barley, and help those who want to limit the rise in blood sugar after a meal choose products to meet their goals, but there are several gaps in the literature that need to be filled before a submission to Health Canada can be successful: 1) test foods in appropriate serving sizes; 2) test both the glucose and insulin response; 3) include a reference product that matches in total fibre, macronutrient, and energy profile; 4) perform dose response. The proposed study design will address all of these gaps in the current literature and take into consideration Health Canada's guidance document for health claims related to the reduction in PPGR, which sets out the criteria by which the validity of such claims will be assessed.

Hypothesis:

Barley β-glucan will reduce the PPGR in healthy participants in a dose dependent manner.

Specific objectives:

  1. To determine the minimum and most effective dose of barley β-glucan in waffles on PPGR and insulin response in a cross-over, randomized, controlled clinical trial.
  2. To assess the effect of barley β-glucan in waffles on appetite-related sensations using visual analog scales.
  3. To demonstrate whether the test and reference products were liked or disliked similarly by participants.
  4. To assess any gastrointestinal side effects from eating the test products

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A double-blind, randomized, controlled, cross-over study designed to examine the PPGR to barley β-glucan will be conducted at the I.H. Asper Clinical Research Institute in Winnipeg, Manitoba. A total of 24 healthy volunteers will participate in the trial. Eligible participants who have provided consent will be asked to attend 5 clinic visits in a fasted state. At each visit hey will be given 1 set of waffles to eat that contains either 0g, 2g, 4g, or 6g of barley β-glucan, 7 finger pokes to collect capillary blood, 5 questionnaires about their appetite and a questionnaire about the acceptability of the quick bread. Each visit will last approximately 2.5h and be separated by 3-14 days.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H2A6
        • I.H. Asper Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Generally healthy male or female, between the age of 18-40 years;
  2. Body mass index (BMI) 18.5-30.0 kg/m2;
  3. Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively;
  4. Willing to provide informed consent;
  5. Willing/able to comply with the requirements of the study.

Exclusion Criteria:

  1. Pregnant or lactating;
  2. Medical history of diabetes mellitus, fasting plasma glucose ≥7.0 mmol/L, HbA1c ≥6.0%, or use of insulin or oral medication to control blood sugar;
  3. Medical history of cardiovascular disease;
  4. Systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg;
  5. Fasting plasma total cholesterol >7.8 mmol/L;
  6. Fasting plasma HDL <0.9 mmol/L;
  7. Fasting plasma LDL >5.0 mmol/L;
  8. Fasting plasma triglycerides >2.3 mmol/L;
  9. Major surgery within the last 3 months;
  10. Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
  11. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
  12. Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
  13. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use with the past 6 weeks;
  14. Active treatment for any type of cancer within 1 year prior to study start;
  15. Other medical, psychiatric, or behavioral factors that in the judgment of the principal Investigator may interfere with study participation or the ability to follow the intervention protocol;
  16. Shift worker (a system of employment where an individual's normal hours of work are in part, outside the period of normal working day; 6am and 8pm);
  17. Smoking, use of tobacco or a nicotine replacement product (within the last 3 months);
  18. Allergies to barley or wheat flour;
  19. Aversion or unwillingness to eat study foods;
  20. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect glycemia;
  21. Participation in another clinical trial, current or in the past 4 weeks;
  22. Unstable body weight (defined as >5% change in 3 months) or actively participating in a weight loss program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control without fibre

Intervention: 0g barley β-glucan no fibre.

Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary supplement: 0g barley β-glucan no fibre
Food containing no barley β-glucan and no additional fibre
Experimental: low barley β-glucan

Intervention: 2g barley β-glucan

Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary supplement: 2g barley β-glucan
Food containing low amounts of barley β-glucan
Experimental: medium barley β-glucan

Intervention: 4g barley β-glucan

Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary supplement: 4g barley β-glucan
Food containing medium amounts of barley β-glucan
Experimental: high barley β-glucan

Intervention: 6g barley β-glucan

Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary supplement: 6g barley β-glucan
Food containing high amounts of barley β-glucan
Placebo Comparator: control with fibre

Intervention: 0g barley β-glucan with fibre

Dose provided in waffles given as breakfast to fasting participant at 1 of 5 visits.
Dietary supplement: 0g barley β-glucan with fibre
Food containing no barley β-glucan, but matches fibre content in β-glucan treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-prandial glucose response
Time Frame: 120 minutes
Incremental area under the curve for glucose (mmol*min/L)
120 minutes
Post-prandial insulin response
Time Frame: 120 min
Incremental area under the curve for insulin (uIU*min/mL)
120 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hunger
Time Frame: 120 min
total area under the curve (AUC) using visual analog scales
120 min
fullness
Time Frame: 120 min
total area under the curve (AUC) using visual analog scales
120 min
desire to eat
Time Frame: 120 min
total area under the curve (AUC) using visual analog scales
120 min
prospective consumption
Time Frame: 120 min
total area under the curve (AUC) using visual analog scales
120 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of waffle color
Time Frame: 15 min
Ratings on a scale of 1-9
15 min
Acceptability of waffle aroma
Time Frame: 15 min
Ratings on a scale of 1-9
15 min
Acceptability of waffle flavor
Time Frame: 15 min
Ratings on a scale of 1-9
15 min
Acceptability of waffle texture
Time Frame: 15 min
Ratings on a scale of 1-9
15 min
Acceptability of waffle frequency of consumption
Time Frame: 15 min
Ratings on a scale of 1-9
15 min
Gastrointestinal side effects
Time Frame: 120 min
self reporting incidence of gastrointestinal effects
120 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Boniface Hospital

Collaborators

Agriculture and Agri-Food Canada

Investigators

  • Principal Investigator: Heather Blewett, PhD, Agriculture and Agri-Food Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2017

Primary Completion (Actual)

August 29, 2018

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimated)

February 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1333

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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