Royal Ancient Oats™ Study (RAO)

January 19, 2026 updated by: Standard Process Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • Recruiting
        • Standard Process Nutrition Innovation Center
        • Principal Investigator:
          • Chinmayee Panda, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Order of receiving muffins differs
Dietary supplement: Royal Ancient Oat Flour™
muffins made with Royal Ancient Oat Flour™
Experimental: B: Order of receiving muffins differs
Dietary supplement: Royal Ancient Oat Flour™
muffins made with Royal Ancient Oat Flour™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 weeks
Area Under the Curve (AUC) for glucose levels over 24 hours, as measured by Continuous Glucose Monitoring (CGM).
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time Frame: 2 weeks
Subjective measures of hunger and satiety using Visual Analog Scales (VAS).
2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time Frame: 2 weeks
Changes in GLP-1 levels (pg/mL)
2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time Frame: 2 weeks
Changes in leptin (pg/mL)
2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time Frame: 2 weeks
Changes in adiponectin (ng/mL)
2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time Frame: 2 weeks
Changes in peptide YY (pg/mL)
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Time Frame: 2 weeks
Changes in body weight (kilograms, kg) measured using a calibrated digital scale (InBody)
2 weeks
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Time Frame: 2 weeks
Changes in waist circumference (centimeters, cm) measured using a flexible, non-stretchable measuring tape at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest.
2 weeks
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Time Frame: 2 weeks
Changes in body fat percentage (%) as measured by bioelectrical impedance analysis (e.g., InBody).
2 weeks
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Time Frame: 2 weeks
Changes in skeletal muscle mass (kg) as measured by bioelectrical impedance analysis (e.g., InBody).
2 weeks
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Time Frame: 2 weeks
Changes in visceral fat level (arbitrary units) as measured by bioelectrical impedance analysis (e.g., InBody).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Standard Process Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SP027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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