Royal Ancient Oats™ muffins versus conventional oat muffins for blood sugar in healthy adults
Impact of Royal Ancient Oats™ on Glycemic Response and Digestive Enzymes
This test will see if high-avenanthramide Royal Ancient Oats™ muffins change blood sugar control compared with conventional oat muffins in non-diabetic overweight or obese adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 35 Years to 65 Years |
| Sex | All |
| Sponsor | Standard Process Inc. Industry-sponsored |
| Locations | 1 site (Kannapolis, North Carolina) |
| Trial ID | NCT07371598 on ClinicalTrials.gov |
What this trial studies
This is a randomized, two-period crossover trial with a three-day run-in baseline and repeated measures to compare high-avenanthramide ancient oat (Royal Ancient Oats™) muffins against conventional oat muffins for effects on glycemic control and related metabolic markers. A total of 38 non-diabetic adults (HbA1c < 5.7%) aged 35–65 with BMI ≥25 are enrolled to provide 90% power to detect a 20% difference in glucose AUC between treatments. Participants begin with three days of baseline white-wheat muffins, then are randomized to muffin sequences with outcome measurements taken across treatment periods. Primary outcomes include postprandial glucose area under the curve and other metabolic parameters following muffin consumption.
Who should consider this trial
Good fit: Non-diabetic adults aged 35–65 with BMI ≥25 (overweight or obese) and HbA1c <5.7% who can follow the study diet and attend site visits.
Not a fit: People with diabetes, those outside the 35–65 age range, normal-weight individuals, or those unable to avoid fiber/supplement confounders are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could offer a low‑risk dietary option to modestly improve post-meal blood sugar control in overweight or obese adults without diabetes.
How similar studies have performed: Prior oat and dietary-fiber studies have shown modest improvements in postprandial glycemia, but the high-avenanthramide ancient oats approach is relatively novel with limited direct clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non-diabetic (HbA1c\<5.7%) adults both men and women between the ages of 35-65 years with body mass index (BMI) ranging from 25 to 30 kg/m2 * Participants who meet the inclusion criteria will be screened prior to starting the study and must be able to adhere to the requirements of the study. * Willing to comply with study procedures and supplement regimens. * Providing consent to participate in the study. * Willing to limit/minimize foods that are rich sources of fiber and high carb content. * Participants should avoid taking any non-prescription/over-the-counter medications or nutritional supplements that could influence glycemic response. This includes vitamins, herbal supplements, and any medications affecting metabolism. Examples include probiotics and prebiotics, vit D, vit B12, Ginseng, fenugreek, weight loss supplements like green tea extract and Garcinia cambogia, fiber supplements like inulin and Psyllium husk. If participants need to make any changes due to health reasons, they should consult with the study coordinator before doing so. Exclusion Criteria: * Participants who have experienced weight loss or gain exceeding 5% of their body weight in the past 3 months, including those involved in any weight loss or weight gain programs through diet and/or lifestyle changes. * Participants currently taking medications that could alter metabolism, such as weight loss medications, anti-hypertensive drugs, or lipid-lowering medications. * Participants with any chronic metabolic diseases, including diabetes, or those using supplements other than a daily multivitamin. * Pregnant or lactating women will be excluded from the study. * Participants who use tobacco products. * Participants who are unwilling to limit or minimize foods that are rich sources of fiber and high carbohydrate content. * Excessive alcohol consumption (e.g., more than two drinks per day for men and more than one drink per day for women) * Inconsistency in recent or planned changes in non-prescription/over-the-counter medications or nutritional supplements affecting glycemic response, including vitamins (e.g., Vitamin D, Vitamin B12), herbal supplements (e.g., Ginseng, Fenugreek), weight loss supplements (e.g., green tea extract, Garcinia cambogia), fiber supplements (e.g., inulin, psyllium husk), and probiotics/prebiotics. * Inability or unwillingness to maintain the current regimen of these medications and supplements throughout the study period without consulting the study coordinator.
Where this trial is running
Kannapolis, North Carolina
- Standard Process Nutrition Innovation Center — Kannapolis, North Carolina, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.