RecruitingNot ApplicableNCT07371598
Royal Ancient Oats™ Study
Impact of Royal Ancient Oats™ on Glycemic Response and Digestive Enzymes
Sponsor
Standard Process Inc.
Enrollment
38 participants
Start Date
Jan 13, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
Evaluating the effects of high avenanthramide ancient oat (Royal Ancient Oats™) muffins versus conventional oat muffins in regard to glycemic control.
Eligibility
Min Age: 35 YearsMax Age: 65 Years
Inclusion Criteria5
- 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.
Exclusion Criteria9
- 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.
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Interventions
DIETARY_SUPPLEMENTRoyal Ancient Oat Flour™
muffins made with Royal Ancient Oat Flour™
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07371598
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