NCT07371598

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 13, 2026

Last Update Submit

January 19, 2026

Conditions

Healthy GlucoseHealthy Participants

Keywords

healthy glucose

Outcome Measures

Primary Outcomes (1)

  • 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).

    2 weeks

Secondary Outcomes (5)

  • To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.

    2 weeks

  • To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.

    2 weeks

  • To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.

    2 weeks

  • To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.

    2 weeks

  • To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.

    2 weeks

Other Outcomes (5)

  • To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.

    2 weeks

  • To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.

    2 weeks

  • To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.

    2 weeks

  • +2 more other outcomes

Study Arms (2)

A: Order of receiving muffins differs

EXPERIMENTAL

A: Order of receiving muffins differs

Dietary Supplement: Royal Ancient Oat Flour™

B: Order of receiving muffins differs

EXPERIMENTAL

B: Order of receiving muffins differs

Dietary Supplement: Royal Ancient Oat Flour™

Interventions

Royal Ancient Oat Flour™DIETARY_SUPPLEMENT

muffins made with Royal Ancient Oat Flour™

A: Order of receiving muffins differsB: Order of receiving muffins differs

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Standard Process Nutrition Innovation Center

Kannapolis, North Carolina, 28081, United States

RECRUITING

Related Publications (14)

  • Shehzad A, Rabail R, Munir S, Jan H, Fernández-Lázaro 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. PMID: 36790719; PMCID: PMC9930024.

    BACKGROUND

  • 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.

    PMID: 35892210BACKGROUND

  • 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.

    PMID: 17513394BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 34977959BACKGROUND

  • 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.

    PMID: 32950005BACKGROUND

  • 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.

    PMID: 34444718BACKGROUND

  • 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)

    BACKGROUND

  • 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).

    BACKGROUND

  • Stewart, D. & McDougall, G. Oat agriculture, cultivation and breeding targets: Implications for human nutrition and health. in British Journal of Nutrition vol. 112 S50-S57 (Cambridge University Press, 2014).

    BACKGROUND

  • 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).

    BACKGROUND

  • Sang, S., & Chu, Y. (2017). Whole grain oats, more than just a fiber: Role of unique phytochemicals. Molecular Nutrition & Food Research, 61(7), 1600715.

    BACKGROUND

  • 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).

    BACKGROUND

  • Coffman, F. A. Oat History, Identification and Classification. (1977).

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 28, 2026

Study Start

January 13, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)