Royal Ancient Oats™ Study for Glycemic Response

This study is looking for healthy adults to understand how different types of oat muffins affect your blood sugar (glycemic response). Researchers are comparing muffins made with Royal Ancient Oat Flour™ and conventional oat muffins to regular white wheat flour muffins. They want to see if Royal Ancient Oat Flour™ can help control blood sugar better. You might be able to join if you are between 35 and 65 years old, do not have diabetes (your HbA1c, a measure of average blood sugar, is less than 5.7%), and have a body mass index (BMI) between 25 and 30. The study aims to enroll 38 participants, but its current status is unclear.

Study design
This is a randomized, two-period crossover study with a run-in control baseline, involving 38 non-diabetic adults.
What's involved
You will start by eating regular flour muffins for three consecutive days, then be assigned to either the conventional oat muffin group or the Royal Ancient Oats™ muffin group. The primary endpoint is measured at 2 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of the study is measured at 2 weeks.

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NCT07371598

Royal Ancient Oats™ Study

Recruiting
NAAges 35–65InterventionalHealth services
Standard Process Inc.
~38 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Royal Ancient Oat Flour™

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To compare the effect of consuming high avenanthramide Royal Ancient Oats™ muffins or conventional oat muffins versus white wheat flour muffins on postprandial glycemic response.
Measured over 2 weeks
Healthy Participants
Healthy Glucose
1 sites across 1 states
North Carolina1

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Eligibility criteria

Inclusion

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
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

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.
  • To compare the effect of consuming high avenanthramide Royal Ancient Oats™ muffins or conventional oat muffins versus white wheat flour muffins on postprandial glycemic response.2 weeks

    Area Under the Curve (AUC) for glucose levels over 24 hours, as measured by Continuous Glucose Monitoring (CGM).