Royal Ancient Oats™ Study

Official title

Impact of Royal Ancient Oats™ on Glycemic Response and Digestive Enzymes

Overview

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.

Interventions

• Dietary supplement Royal Ancient Oat Flour™
  muffins made with Royal Ancient Oat Flour™

Primary outcome measures

• 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]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Health services research

Study locations

United States · 1 center

• Standard Process Nutrition Innovation Center — Kannapolis

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. PMID 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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 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)

Identifiers

NCT: NCT07371598 · SP027

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗