Effects of Barley on Glucose Control

NCT02367989 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-29

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

0g barley β-glucan no fibre

Food containing no barley β-glucan and no additional fibre

DIETARY_SUPPLEMENT

2g barley β-glucan

Food containing low amounts of barley β-glucan

DIETARY_SUPPLEMENT

4g barley β-glucan

Food containing medium amounts of barley β-glucan

DIETARY_SUPPLEMENT

6g barley β-glucan

Food containing high amounts of barley β-glucan

DIETARY_SUPPLEMENT

0g barley β-glucan with fibre

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

Sponsors & Collaborators

  • Agriculture and Agri-Food Canada

    collaborator OTHER_GOV
  • St. Boniface Hospital

    lead OTHER

Principal Investigators

  • Heather Blewett, PhD · Agriculture and Agri-Food Canada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2018-08-29
Completion
2025-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367989 on ClinicalTrials.gov