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Trial record 5 of 15 for:    meal | barley

Effects of Barley on Glucose Control

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ClinicalTrials.gov Identifier: NCT02367989
Recruitment Status : Active, not recruiting
First Posted : February 20, 2015
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Dr. Heather Blewett, St. Boniface General Hospital Research Centre

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: 0g barley β-glucan no fibre Dietary Supplement: 2g barley β-glucan Dietary Supplement: 4g barley β-glucan Dietary Supplement: 6g barley β-glucan Dietary Supplement: 0g barley β-glucan with fibre Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : August 29, 2018
Estimated Study Completion Date : March 2020

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




Primary Outcome Measures :
  1. Post-prandial glucose response [ Time Frame: 120 minutes ]
    Incremental area under the curve for glucose (mmol*min/L)

  2. Post-prandial insulin response [ Time Frame: 120 min ]
    Incremental area under the curve for insulin (uIU*min/mL)


Secondary Outcome Measures :
  1. hunger [ Time Frame: 120 min ]
    total area under the curve (AUC) using visual analog scales

  2. fullness [ Time Frame: 120 min ]
    total area under the curve (AUC) using visual analog scales

  3. desire to eat [ Time Frame: 120 min ]
    total area under the curve (AUC) using visual analog scales

  4. prospective consumption [ Time Frame: 120 min ]
    total area under the curve (AUC) using visual analog scales


Other Outcome Measures:
  1. Acceptability of waffle color [ Time Frame: 15 min ]
    Ratings on a scale of 1-9

  2. Acceptability of waffle aroma [ Time Frame: 15 min ]
    Ratings on a scale of 1-9

  3. Acceptability of waffle flavor [ Time Frame: 15 min ]
    Ratings on a scale of 1-9

  4. Acceptability of waffle texture [ Time Frame: 15 min ]
    Ratings on a scale of 1-9

  5. Acceptability of waffle frequency of consumption [ Time Frame: 15 min ]
    Ratings on a scale of 1-9

  6. Gastrointestinal side effects [ Time Frame: 120 min ]
    self reporting incidence of gastrointestinal effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367989


Locations
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Canada, Manitoba
I.H. Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H2A6
Sponsors and Collaborators
St. Boniface General Hospital Research Centre
Agriculture and Agri-Food Canada
Investigators
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Principal Investigator: Heather Blewett, PhD Agriculture and Agri-Food Canada

Publications:
Canadian Diabetes Association. Canadian diabetes association 2008 clinical practice guidelines for the prevention and management of diabetes in Canada. Canadian Journal of Diabetes. 2008;32(1).
Health Canada. Summary of health Canada's assessment of a health claim about barley products and blood cholesterol lowering. [Internet].; 2012. Available from: http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assess-evalu/barley-orge-eng.php.
European Food Safety Authority. Guidance on the scientific requirements for health claims related to appetite ratings, weight management, and blood glucose concentrations. EFSA Journal. 2012;10(3):2604.

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Responsible Party: Dr. Heather Blewett, Research Scientist, St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier: NCT02367989     History of Changes
Other Study ID Numbers: 1333
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Heather Blewett, St. Boniface General Hospital Research Centre:
Glucose response
Insulin response
Satiety