Evaluating the effects of high avenanthramide ancient oat (Royal Ancient Oats™) muffins versus conventional oat muffins in regard to glycemic control.
This study is a randomized, two-period crossover trial with a run-in control baseline and repeated measures, designed to evaluate the effects of high avenanthramide ancient oat (Royal Ancient Oats™) muffins versus conventional oat muffins on glycemic control and related metabolic parameters. A total of 38 non-diabetic adults (HbA1c \< 5.7%), who are either overweight (BMI 25-29.9) or obese (BMI ≥ 30) will start with a repeated measures baseline using regular flour (white wheat) muffins for three consecutive days. Following this, participants will be divided into two groups: 19 in the conventional oat muffin group and 19 in the Royal Ancient Oats™ muffin group. This sample size provides 90% power to detect a difference in AUC of at least 20% between treatments, with a two-sided alpha of 0.05.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
38
muffins made with Royal Ancient Oat Flour™
Standard Process Nutrition Innovation Center
Kannapolis, North Carolina, United States
RECRUITINGTo compare the effect of consuming high avenanthramide Royal Ancient Oats™ muffins or conventional oat muffins versus white wheat flour muffins on postprandial glycemic response.
Area Under the Curve (AUC) for glucose levels over 24 hours, as measured by Continuous Glucose Monitoring (CGM).
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Subjective measures of hunger and satiety using Visual Analog Scales (VAS).
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in GLP-1 levels (pg/mL)
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in leptin (pg/mL)
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in adiponectin (ng/mL)
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in peptide YY (pg/mL)
Time frame: 2 weeks
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