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OpenTrials
Completed

NCT Number: NCT06146322

Barley Beta-glucan, Glycemic Control, and Appetite

Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve population health through improving glycemic control. Sweetened and unsweetened wholegrain barley foods were tested in a randomized, controlled, crossover human clinical trial to assess impact on postprandial appetite and food intake.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington State University

Spokane, Washington, 99202, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-50 years of age
  • Body Mass Index (BMI) values of 18.5-40.0 kg/m2
  • Normal fasting blood glucose (<100 mg/dL)

Exclusion criteria

  • Use of medications known to be associated with weight change (e.g., beta-blockers)
  • Use of steroid pills or shots such as prednisone or cortisone
  • Use of nicotine
  • Weight change of ten or more pounds in the last three months
  • Major daily variation in physical activity (e.g., athletes in training)
  • History of extensive small bowel surgery or surgery to treat obesity
  • History of heart attack, stroke, or bypass
  • History of cancer within the last five years (exception: non-melanoma skin cancer)
  • Recent or current medical diagnosis or medical treatment that would alter appetite, energy needs, satiety, and/or could impact the results of the trial
  • Medical diagnoses of diabetes, cardiovascular disease, high levels of blood lipids, asthma, cold, and flu (exception: hypertension, if treated with medication prescribed more than three months prior to the screening activity)
  • Fear of blood or needles
  • Dietary restrictions that would interfere with consuming test foods (e.g., gluten intolerance, vegan, corn syrup allergy)
  • Following a weight modification diet
  • Sensitive to food textures present in the test foods
  • Following personal schedules that would not permit attendance at all scheduled testing sessions
  • Unable to comprehend the nature of the trial or instructions
  • Unable to understand English sufficiently to complete the trial

Treatment and study plan

WR

Other

Unsweetened preload condition: 240 mL white glutinous rice, 250 kcal, 0 g β-glucan

LB

Other

Unsweetened preload condition: 240 mL low β-glucan barley, 250 kcal, ~4 g β-glucan

MB

Other

Unsweetened preload condition: 240 mL medium β-glucan barley, 250 kcal, ~5 g β-glucan

HB

Other

Unsweetened preload condition: 240 mL high β-glucan barley, 250 kcal, ~6 g β-glucan

WR+50g HFCS

Other

Sweetened condition with high fructose corn syrup (HFCS): 240 mL white glutinous rice + 50g HFCS, 391 kcal, 0 g β-glucan

LB + 50 g HFCS

Other

Sweetened condition with high fructose corn syrup (HFCS): 240 mL low β-glucan barley + 50 g HFCS, 391 kcal, ~4 g β-glucan

MB + 50 g HFCS

Other

Sweetened condition with high fructose corn syrup (HFCS): 240 mL medium β-glucan barley + 50 g HFCS, 391 kcal, ~5 g β-glucan

HB + 50 g HFCS

Other

Sweetened condition with high fructose corn syrup (HFCS): 240 mL high β-glucan barley + 50 g HFCS, 391 kcal, ~6 g β-glucan

Primary outcomes

  1. Postprandial glycemic response

    Time frame: 4 hours

    Blood glucose measured every 15 minutes post-preload ingestion

  2. Subjective appetite

    Time frame: 4 hours

    Self-reported appetite measured using Visual Analogue Scale (VAS) every 15 minutes post-preload ingestion

  3. Food intake

    Time frame: 30 minutes

    Food intake at a 16-item ad libitum test meal served 4 hours post-preload ingestion

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 24, 2023
Registry last updated
Nov 24, 2023

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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