Barley Beta-glucan, Glycemic Control, and Appetite

Sponsor

Washington State University (Other)

Overall Status

Completed

CT.gov ID

NCT06146322

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy Blood Sugar; High Diabetes Appetite and General Nutritional Disorders Appetitive Behavior	Other: WR Other: LB Other: MB Other: HB Other: WR+50g HFCS Other: LB + 50 g HFCS Other: MB + 50 g HFCS Other: HB + 50 g HFCS	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Barley Beta-glucan, Glycemic Control, and Appetite

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Outcome Measures

Primary Outcome Measures

Postprandial glycemic response [4 hours]
Blood glucose measured every 15 minutes post-preload ingestion
Subjective appetite [4 hours]
Self-reported appetite measured using Visual Analogue Scale (VAS) every 15 minutes post-preload ingestion
Food intake [30 minutes]
Food intake at a 16-item ad libitum test meal served 4 hours post-preload ingestion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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