NCT07371598

Royal Ancient Oats™ Study

Impact of Royal Ancient Oats™ on Glycemic Response and Digestive Enzymes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Standard Process Inc. · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluating the effects of high avenanthramide ancient oat (Royal Ancient Oats™) muffins versus conventional oat muffins in regard to glycemic control.

Detailed description

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.

Conditions

• Healthy Participants
• Healthy Glucose

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Royal Ancient Oat Flour™	muffins made with Royal Ancient Oat Flour™

Timeline

• Start date: 2026-01-13
• Primary completion: 2026-06-30
• Completion: 2026-09-15
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States