Diabetes Clinical Trial
Official title:
Barley Beta-glucan, Glycemic Control, and Appetite
NCT number | NCT06146322 |
Other study ID # | 17735 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | October 31, 2020 |
Verified date | November 2023 |
Source | Washington State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington State University | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Washington State University |
United States,
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 |
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