Recruiting

Royal Ancient Oats™ vs. Conventional Oats

Sponsor:

Standard Process Inc.

Code:

NCT07371598

Conditions

Healthy Participants

Healthy Glucose

Eligibility Criteria

Sex: All

Age: 35 - 65

Healthy Volunteers: Accepted

Interventions

Royal Ancient Oat Flour™

Study Details

Brief summary:

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

Conditions

Healthy Participants

Healthy Glucose

Study ID

NCT07371598

Start date

Jan 13, 2026

Status verified date

Jan, 2026

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: A: Order of receiving muffins differs

A: Order of receiving muffins differs

experimental: B: Order of receiving muffins differs

B: Order of receiving muffins differs

Interventions

Royal Ancient Oat Flour™

muffins made with Royal Ancient Oat Flour™

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 ]

Central Contacts and Locations

Locations

Standard Process Nutrition Innovation Center

Recruiting

Kannapolis, North Carolina, United States, 28081

Contacts

Brea Nance

2624956410spclinic@standardprocess.com

Principal Investigator:

Chinmayee Panda, PhD

More Information

Sponsor

Standard Process Inc.

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • healthy glucose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Standard Process Inc. on 2026-01-28.