๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-11-26

Effects of Barley on Glucose Control (NCT02367989)

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

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: St. Boniface Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 ฮฒ-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 ฮฒ-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 ฮฒ-glucan in waffles on PPGR and insulin response in a cross-over, randomized, controlled clinical trial. 2. To assess the effect of barley ฮฒ-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

Who can join: Review the eligibility criteria below.

Location: I.H. Asper Clinical Research Institute โ€” Winnipeg, Manitoba

Age range: 18 Years to 40 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

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Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • I.H. Asper Clinical Research Institute โ€” Winnipeg, Manitoba

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—