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OpenTrials
Completed

NCT Number: NCT03387345

Barley and Rice Mixture Effects on Blood Glucose

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Biomedical Collaborative

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

100% steel cut barley

Other

25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).

100% barley flakes

Other

25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).

50/50 rice-barley mix

Other

25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).

80/20 rice-barley mix

Other

25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).

100% rice

Other

25 g of available carbohydrate was delivered to participants via Goya medium grain white rice

White Bread

Other

25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)

Primary outcomes

  1. Post-prandial glycemia

    Time frame: 0 min, 15 min, 30 min, 45min , 60 min, 90 min, 120 min

    Incremental area under the curve(iAUC) for plasma glucose concentrations were measured at 0, 15, 30, 45, 60, 90 and 120 min using the trapezoidal method to evaluate the glycemic response to each grain treatment.

Secondary outcomes

  1. Self-reported hunger

    Time frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min

    Visual analog scales were used to evaluate self-reported feelings of hunger using the question "How hungry do you feel?" The scale consisted of a 100-millimeter line with anchors "I am not hungry at all" and "I have never been more hungry" at 0 and 100 millimeters, respectively. Lower numbers represent low feelings of hunger while larger values are characteristic of greater hunger. Hunger was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.

  2. Self-reported satiety

    Time frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min

    Visual analog scales were used to evaluate self-reported feelings of satiety using the question "How satisfied do you feel?" The scale consisted of a 100-millimeter line with anchors "I am completely empty" and "I cannot eat another bite" at 0 and 100 millimeters, respectively. Lower numbers represent low feelings of satiety while larger values are characteristic of greater satiety. Satiety was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.

  3. Self-reported fullness

    Time frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min

    Visual analog scales were used to evaluate self-reported feelings of fullness using the question "How full do you feel?" The scale consisted of a 100-millimeter line with anchors "Not at all full" and "Totally full" at 0 and 100 millimeters, respectively. Lower numbers represent low feelings of fullness while larger values are characteristic of greater fullness. Fullness was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.

  4. Self-reported prospective food consumption

    Time frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min

    Visual analog scales were used to evaluate self-reported feelings toward prospective food consumption using the question "How much do you think you can eat?" The scale consisted of a 100-millimeter line with anchors "Nothing at all" and "A lot" at 0 and 100 millimeters, respectively. Lower numbers represent low ability to eat while larger values are characteristic of greater ability to eat. Prospective food consumption was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Ardent Mills, LLC

Registry information

Official study title

β-glucan Rich Barley and Rice Mixes and Post-prandial Glycemia - a Dose Response Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 2, 2018
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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