Clinical trial NCT03387345: Barley and Rice Mixture Effects on Blood Glucose
Official title: β-glucan Rich Barley and Rice Mixes and Post-prandial Glycemia - a Dose Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Dietary Fiber
Hunger
Keywords: glucose
dietary fiber
glycemia
whole grain
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Ardent Mills, LLC
First posted: 2018-01-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Otherwise healthy male and female adults
Primary purpose: PREVENTION

Brief summary: The purpose of this research was to investigate 5 different formulations of whole grain barley and refined white rice against a control of white bread on post-prandial glycemic response, as well as self-reported hunger/satiety in a randomized cross-over trial.

Detailed description: Beta-glucan-rich barley has been shown to improve glycemic response, reduce hunger and increase satiety. Nutrient-dense grain mixtures that include a new cultivar of barley (Sustagrain, Ardent Mills, LLC) with exceptionally high dietary fiber content may help individuals meet their dietary fiber needs while minimizing the rapid increase in blood glucose following the consumption of a refined grain product. The primary objective of this study was to compare the effects of five different test meals containing varying amounts of whole-grain barley and refined white rice to white bread on post-prandial blood glucose concentrations. A secondary aim was to evaluate changes in self-reported hunger and satiety following the consumption of each treatment. This study was a single-site, blinded, randomized crossover trial among 24 healthy adults. Each participant consumed the following treatments: 100% Sustagrain barley flakes, 100% Sustagrain steel cut barley , an 80/20 rice-steel cut Sustagrain barley mix, a 50/50 rice-steel cut Sustagrain barley mix, 100% rice, and white bread.

Eligibility criteria: Inclusion Criteria:

* Healthy, English speaking adults;
* BMI between 18 and 30 kg/m2

Exclusion Criteria:

* History of GI malabsorption diseases, food allergy or intolerance to gluten;
* Prediabetes, and/or diabetes, and/or treatment with diabetic medications for any reason;
* Hypertension, hypothyroidism and other chronic disease that affects nutrient metabolism;
* Any women pregnant or lactating, or expecting to become pregnant during the study;
* Individuals with a history of bleeding disorders

Primary outcomes:
measure: Post-prandial glycemia
timeFrame: 0 min, 15 min, 30 min, 45min , 60 min, 90 min, 120 min
Secondary outcomes:
measure: Self-reported hunger
timeFrame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
measure: Self-reported satiety
timeFrame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
measure: Self-reported fullness
timeFrame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
measure: Self-reported prospective food consumption
timeFrame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Biomedical Collaborative
state: Arizona
Study officials:
affiliation: Arizona State University
name: Corrie M Whisner, PhD
role: PRINCIPAL_INVESTIGATOR
References: