Impact of Royal Ancient Oats™ on Glycemic Response and Digestive Enzymes
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Standard Process Inc.
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
A: Order of receiving muffins differs
A: Order of receiving muffins differs
Intervention: Royal Ancient Oat Flour™ (Dietary Supplement)
B: Order of receiving muffins differs
B: Order of receiving muffins differs
Intervention: Royal Ancient Oat Flour™ (Dietary Supplement)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.(2 weeks)