Barley Beta-glucan, Glycemic Control, and Appetite

Diabetes Clinical Trial

Official title:

Barley Beta-glucan, Glycemic Control, and Appetite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06146322
• Other study ID #: 17735
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetite and General Nutritional Disorders
• Appetitive Behavior
• Blood Sugar; High
• Diabetes
• Diet, Healthy
• Hyperglycemia
• Nutrition Disorders

Intervention

Other:
• WR
Unsweetened preload condition: 240 mL white glutinous rice, 250 kcal, 0 g ß-glucan
• LB
Unsweetened preload condition: 240 mL low ß-glucan barley, 250 kcal, ~4 g ß-glucan
• MB
Unsweetened preload condition: 240 mL medium ß-glucan barley, 250 kcal, ~5 g ß-glucan
• HB
Unsweetened preload condition: 240 mL high ß-glucan barley, 250 kcal, ~6 g ß-glucan
• WR+50g HFCS
Sweetened condition with high fructose corn syrup (HFCS): 240 mL white glutinous rice + 50g HFCS, 391 kcal, 0 g ß-glucan
• LB + 50 g HFCS
Sweetened condition with high fructose corn syrup (HFCS): 240 mL low ß-glucan barley + 50 g HFCS, 391 kcal, ~4 g ß-glucan
• MB + 50 g HFCS
Sweetened condition with high fructose corn syrup (HFCS): 240 mL medium ß-glucan barley + 50 g HFCS, 391 kcal, ~5 g ß-glucan
• HB + 50 g HFCS
Sweetened condition with high fructose corn syrup (HFCS): 240 mL high ß-glucan barley + 50 g HFCS, 391 kcal, ~6 g ß-glucan

Locations

Country	Name	City	State
United States	Washington State University	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemic response	Blood glucose measured every 15 minutes post-preload ingestion	4 hours
Primary	Subjective appetite	Self-reported appetite measured using Visual Analogue Scale (VAS) every 15 minutes post-preload ingestion	4 hours
Primary	Food intake	Food intake at a 16-item ad libitum test meal served 4 hours post-preload ingestion	30 minutes