Effects of Barley on Glucose Control

NCT02367989 | Active Not Recruiting

• 1 other identifier: 1333
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 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. 2.To assess the effect of barley β-glucan in waffles on appetite-related sensations using visual analog scales.
3. 3.To demonstrate whether the test and reference products were liked or disliked similarly by participants.
4. 4.To assess any gastrointestinal side effects from eating the test products

Conditions

Healthy

Keywords

Glucose response; Insulin response; Satiety

Outcome Measures

Primary Outcomes (2)

• Post-prandial glucose response

  Incremental area under the curve for glucose (mmol\*min/L)

  120 minutes

• Post-prandial insulin response

  Incremental area under the curve for insulin (uIU\*min/mL)

  120 min

Secondary Outcomes (4)

• hunger

  120 min

• fullness

  120 min

• desire to eat

  120 min

• prospective consumption

  120 min

Other Outcomes (6)

• Acceptability of waffle color

  15 min

• Acceptability of waffle aroma

  15 min

• Acceptability of waffle flavor

  15 min

Study Arms (5)

Control without fibre

PLACEBO COMPARATOR

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

low barley β-glucan

EXPERIMENTAL

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

medium barley β-glucan

EXPERIMENTAL

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

high barley β-glucan

EXPERIMENTAL

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

control with fibre

PLACEBO COMPARATOR

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

Interventions

0g barley β-glucan no fibre DIETARY_SUPPLEMENT

Food containing no barley β-glucan and no additional fibre

Control without fibre

2g barley β-glucan DIETARY_SUPPLEMENT

Food containing low amounts of barley β-glucan

low barley β-glucan

4g barley β-glucan DIETARY_SUPPLEMENT

Food containing medium amounts of barley β-glucan

medium barley β-glucan

6g barley β-glucan DIETARY_SUPPLEMENT

Food containing high amounts of barley β-glucan

high barley β-glucan

0g barley β-glucan with fibre DIETARY_SUPPLEMENT

Food containing no barley β-glucan, but matches fibre content in β-glucan treatments

control with fibre

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating;
• 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;
• Medical history of cardiovascular disease;
• Systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg;
• Fasting plasma total cholesterol \>7.8 mmol/L;
• Fasting plasma HDL \<0.9 mmol/L;
• Fasting plasma LDL \>5.0 mmol/L;
• Fasting plasma triglycerides \>2.3 mmol/L;
• Major surgery within the last 3 months;
• Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis) or use of any corticosteroid medications within 3 months;
• Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥1.5 times the upper limit of normal (ULN));
• Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN));
• 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;
• Active treatment for any type of cancer within 1 year prior to study start;
• 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;

Sponsors & Collaborators

• St. Boniface Hospital: lead
• Agriculture and Agri-Food Canada: collaborator

Study Sites (1)

I.H. Asper Clinical Research Institute

Winnipeg, Manitoba, R2H2A6, Canada

Location

Related Publications (14)

• Ames NP, Rhymer CR. Issues surrounding health claims for barley. J Nutr. 2008 Jun;138(6):1237S-43S. doi: 10.1093/jn/138.6.1237S.

  PMID: 18492863 BACKGROUND

• Aziz A, Dumais L, Barber J. Health Canada's evaluation of the use of glycemic index claims on food labels. Am J Clin Nutr. 2013 Aug;98(2):269-74. doi: 10.3945/ajcn.113.061770. Epub 2013 Jun 12.

  PMID: 23761481 BACKGROUND

• Biorklund M, van Rees A, Mensink RP, Onning G. Changes in serum lipids and postprandial glucose and insulin concentrations after consumption of beverages with beta-glucans from oats or barley: a randomised dose-controlled trial. Eur J Clin Nutr. 2005 Nov;59(11):1272-81. doi: 10.1038/sj.ejcn.1602240.

  PMID: 16015250 BACKGROUND

• Casiraghi MC, Garsetti M, Testolin G, Brighenti F. Post-prandial responses to cereal products enriched with barley beta-glucan. J Am Coll Nutr. 2006 Aug;25(4):313-20. doi: 10.1080/07315724.2006.10719541.

  PMID: 16943453 BACKGROUND

• Chillo S, Ranawana DV, Pratt M, Henry CJ. Glycemic response and glycemic index of semolina spaghetti enriched with barley beta-glucan. Nutrition. 2011 Jun;27(6):653-8. doi: 10.1016/j.nut.2010.07.003. Epub 2010 Sep 24.

  PMID: 20869206 BACKGROUND

• de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. doi: 10.1093/ajcn/79.6.946.

  PMID: 15159223 BACKGROUND

• Poppitt SD, van Drunen JD, McGill AT, Mulvey TB, Leahy FE. Supplementation of a high-carbohydrate breakfast with barley beta-glucan improves postprandial glycaemic response for meals but not beverages. Asia Pac J Clin Nutr. 2007;16(1):16-24.

  PMID: 17215176 BACKGROUND

• Thondre PS, Henry CJ. Effect of a low molecular weight, high-purity beta-glucan on in vitro digestion and glycemic response. Int J Food Sci Nutr. 2011 Nov;62(7):678-84. doi: 10.3109/09637486.2011.566849. Epub 2011 May 12.

  PMID: 21561391 BACKGROUND

• Thondre PS, Wang K, Rosenthal AJ, Henry CJ. Glycaemic response to barley porridge varying in dietary fibre content. Br J Nutr. 2012 Mar;107(5):719-24. doi: 10.1017/S0007114511003461. Epub 2011 Jul 26.

  PMID: 21787456 BACKGROUND

• Tosh SM. Review of human studies investigating the post-prandial blood-glucose lowering ability of oat and barley food products. Eur J Clin Nutr. 2013 Apr;67(4):310-7. doi: 10.1038/ejcn.2013.25. Epub 2013 Feb 20.

  PMID: 23422921 BACKGROUND

• 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).

  BACKGROUND

• Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.

  PMID: 24070926 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Heather Blewett, PhD

  Agriculture and Agri-Food Canada

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 20, 2015
• Study Start: November 8, 2017
• Primary Completion: August 29, 2018
• Study Completion: January 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)