RecruitingNCT07371598RAOUpdated Jan 28, 2026

Royal Ancient Oats™ Study

An interventional study of Royal Ancient Oat Flour™ in Healthy Participants and Healthy Glucose, sponsored by Standard Process Inc.. Recruiting at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Standard Process Inc. · Not applicable, Interventional, and Health services research

From the registry’s dates

Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
Started Jan 2026; still recruiting 8 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 38
Allocation: Randomized
Ages: 35 Years to 65 Years
Sex: All

Study summary

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

Read the 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 studied

Healthy Participants
Healthy Glucose

Keywords

healthy glucose

In context

Lead sponsor

Standard Process Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Health services research
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 38 participants (estimated)

Study arms

Experimental
A: Order of receiving muffins differs
A: Order of receiving muffins differs
Dietary Supplement: Royal Ancient Oat Flour™
Experimental
B: Order of receiving muffins differs
B: Order of receiving muffins differs
Dietary Supplement: Royal Ancient Oat Flour™

Interventions

Dietary supplementRoyal Ancient Oat Flour™
muffins made with Royal Ancient Oat Flour™

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Other outcomes

To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Changes in body weight (kilograms, kg) measured using a calibrated digital scale (InBody)
Time frame: 2 weeks
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
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.
Time frame: 2 weeks
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Changes in body fat percentage (%) as measured by bioelectrical impedance analysis (e.g., InBody).
Time frame: 2 weeks
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Changes in skeletal muscle mass (kg) as measured by bioelectrical impedance analysis (e.g., InBody).
Time frame: 2 weeks
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Changes in visceral fat level (arbitrary units) as measured by bioelectrical impedance analysis (e.g., InBody).
Time frame: 2 weeks

Study locations

1 of 1 sites recruiting

Standard Process Nutrition Innovation Center
Kannapolis, North Carolina 28081, United States
- Brea Nance · Contact · spclinic@standardprocess.com · 2624956410
- Chinmayee Panda, PhD · Principal investigator
Recruiting

References and documents

Publications

Shehzad A, Rabail R, Munir S, Jan H, Fernandez-Lazaro D, Aadil RM. Impact of Oats on Appetite Hormones and Body Weight Management: A Review. Curr Nutr Rep. 2023 Mar;12(1):66-82. doi: 10.1007/s13668-023-00454-3. Epub 2023 Feb 15. PubMed 36790719 ↗
Zhouyao H, Malunga LN, Chu YF, Eck P, Ames N, Thandapilly SJ. The inhibition of intestinal glucose absorption by oat-derived avenanthramides. J Food Biochem. 2022 Oct;46(10):e14324. doi: 10.1111/jfbc.14324. Epub 2022 Jul 27. PubMed 35892210 ↗
Chen CY, Milbury PE, Collins FW, Blumberg JB. Avenanthramides are bioavailable and have antioxidant activity in humans after acute consumption of an enriched mixture from oats. J Nutr. 2007 Jun;137(6):1375-82. doi: 10.1093/jn/137.6.1375. PubMed 17513394 ↗
Chen V, Zurbau A, Ahmed A, Khan TA, Au-Yeung F, Chiavaroli L, Blanco Mejia S, Leiter LA, Jenkins DJA, Kendall CWC, Sievenpiper JL. Effect of oats and oat ß-glucan on glycemic control in diabetes: a systematic review and meta-analysis of randomized controlled trials. BMJ Open Diabetes Res Care. 2022 Sep 1;10(5):e002784. doi: 10.1136/bmjdrc-2022-002784. PMCID: PMC9438016.
Llanaj E, Dejanovic GM, Valido E, Bano A, Gamba M, Kastrati L, Minder B, Stojic S, Voortman T, Marques-Vidal P, Stoyanov J, Metzger B, Glisic M, Kern H, Muka T. Effect of oat supplementation interventions on cardiovascular disease risk markers: a systematic review and meta-analysis of randomized controlled trials. Eur J Nutr. 2022 Jun;61(4):1749-1778. doi: 10.1007/s00394-021-02763-1. Epub 2022 Jan 3. PubMed 34977959 ↗
Raguindin PF, Adam Itodo O, Stoyanov J, Dejanovic GM, Gamba M, Asllanaj E, Minder B, Bussler W, Metzger B, Muka T, Glisic M, Kern H. A systematic review of phytochemicals in oat and buckwheat. Food Chem. 2021 Feb 15;338:127982. doi: 10.1016/j.foodchem.2020.127982. Epub 2020 Sep 5. PubMed 32950005 ↗
Wehrli F, Taneri PE, Bano A, Bally L, Blekkenhorst LC, Bussler W, Metzger B, Minder B, Glisic M, Muka T, Kern H. Oat Intake and Risk of Type 2 Diabetes, Cardiovascular Disease and All-Cause Mortality: A Systematic Review and Meta-Analysis. Nutrients. 2021 Jul 26;13(8):2560. doi: 10.3390/nu13082560. PubMed 34444718 ↗
Loskutov, I. G., Gnutikov, A. A., Blinova, E. V. & Rodionov, A. V. The Origin and Resource Potential of Wild and Cultivated Species of the Genus of Oats (Avena L.). Russ J Genet 57, 642-661 (2021)
Sood, V. K., Sanadya, S. K., Kumar, S., Chand, S. & Kapoor, R. Health benefits of oat (Avena sativa) and nutritional improvement through plant breeding interventions. Crop Pasture Sci 74, 993-1013 (2022).
Stewart D, McDougall G. Oat agriculture, cultivation and breeding targets: implications for human nutrition and health. Br J Nutr. 2014 Oct;112 Suppl 2:S50-7. doi: 10.1017/S0007114514002736. PubMed 25267245 ↗
Ociepa, T. The oat gene pools - Review about the use of wild species in improving cultivated oat. Journal of Central European Agriculture 20, 251-261 (2019).
Sang S, Chu Y. Whole grain oats, more than just a fiber: Role of unique phytochemicals. Mol Nutr Food Res. 2017 Jul;61(7). doi: 10.1002/mnfr.201600715. Epub 2017 Feb 22. PubMed 28067025 ↗
Pearson, R. W., Aldrich, D. G., H Allaway J E Dawson, J. W. & Gardner E G Heyne F L Patterson, C. O. Oats and Oat Improvement. vol. 4 https://acsess.onlinelibrary.wiley.com/doi/ (1952).
Coffman, F. A. Oat History, Identification and Classification. (1977).

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07371598
Lead sponsor: Standard Process Inc.
Responsible party: Sponsor
First posted: Jan 28, 2026
Start date: Jan 13, 2026
Primary completion: Jun 30, 2026 (estimated)
Completion: Sep 15, 2026 (estimated)
Last update: Jan 28, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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