Healthy ParticipantsRAONCT07371598
Royal Ancient Oats™ Study
A study testing Royal Ancient Oat Flour™ in people with Healthy Participants and Healthy Glucose, run by Standard Process Inc. at 1 site in United States.
Trial summary
Evaluating the effects of high avenanthramide ancient oat (Royal Ancient Oats™) muffins versus conventional oat muffins in regard to glycemic control. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Healthy Glucose
- What is being tested?
- Royal Ancient Oat Flour™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Standard Process Nutrition Innovation Center
Kannapolis, North Carolina, 28081
Brea Nance, 2624956410, spclinic@standardprocess.com
Chinmayee Panda, PhD
About this study
Official title: 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.
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
- Healthy Participants, Healthy Glucose
- Being tested
- Royal Ancient Oat Flour™
- Keywords
- healthy glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Royal Ancient Oat Flour™Dietary supplement
muffins made with Royal Ancient Oat Flour™
| Study group | Role | What they receive |
|---|---|---|
| A: Order of receiving muffins differs | Experimental | A: Order of receiving muffins differs Receives: Dietary Supplement: Royal Ancient Oat Flour™ |
| B: Order of receiving muffins differs | Experimental | B: Order of receiving muffins differs Receives: Dietary Supplement: Royal Ancient Oat Flour™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (5)
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).
Measured: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in GLP-1 levels (pg/mL)
Measured: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in leptin (pg/mL)
Measured: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in adiponectin (ng/mL)
Measured: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in peptide YY (pg/mL)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start13 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371598
- Sponsor's protocol ID
- SP027
- Acronym
- RAO
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 36790719Zhouyao 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 35892210Chen 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 17513394Chen 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 34977959Raguindin 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 32950005Wehrli 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 34444718Loskutov, 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 25267245Ociepa, 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 28067025Pearson, 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).
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Royal Ancient Oats™ on Glycemic Response and Digestive Enzymes
- ClinicalTrials.gov ID
- NCT07371598
- Acronym / sponsor ID
- RAO / SP027
- Conditions
- Healthy Participants, Healthy Glucose
- Keywords
- healthy glucose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Order of receiving muffins differs | Experimental | Dietary Supplement: Royal Ancient Oat Flour™A: Order of receiving muffins differs |
| B: Order of receiving muffins differs | Experimental | Dietary Supplement: Royal Ancient Oat Flour™B: Order of receiving muffins differs |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Royal Ancient Oat Flour™muffins made with Royal Ancient Oat Flour™ | Dietary supplement | A: Order of receiving muffins differs, B: Order of receiving muffins differs |
Primary outcome
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).
5 secondary outcomes
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time frame: 2 weeks
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 36790719Shehzad 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.
- Background: PubMed 35892210Zhouyao 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.
- Background: PubMed 17513394Chen 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.
- BackgroundChen 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.
- Background: PubMed 34977959Llanaj 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.
- Background: PubMed 32950005Raguindin 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.
- Background: PubMed 34444718Wehrli 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.
- BackgroundLoskutov, 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)
- BackgroundSood, 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).
- Background: PubMed 25267245Stewart 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.
- BackgroundOciepa, 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).
- Background: PubMed 28067025Sang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Standard Process Nutrition Innovation Center
Kannapolis, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Royal Ancient Oat Flour™ in people with Healthy Participants and Healthy Glucose, run by Standard Process Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07371598, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.