Royal Ancient Oats™ Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorStandard Process Inc.
About this trial
Evaluating the effects of high avenanthramide ancient oat (Royal Ancient Oats™) muffins versus conventional oat muffins in regard to glycemic control.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Royal Ancient Oat Flour™
Dietary supplementmuffins made with Royal Ancient Oat Flour™
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: A: Order of receiving muffins differsExperimental treatment 1 intervention
Group B: B: Order of receiving muffins differsExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
2 weeksSecondary outcomes
1
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Subjective measures of hunger and satiety using Visual Analog Scales (VAS).
Time frame
2 weeks2
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in GLP-1 levels (pg/mL)
Time frame
2 weeks3
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in leptin (pg/mL)
Time frame
2 weeks4
To evaluate the effect of Royal Ancient Oats™ on incretin hormone secretion and satiety hormones.
Changes in adiponectin (ng/mL)
Time frame
2 weeksOther outcomes
1
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Changes in body weight (kilograms, kg) measured using a calibrated digital scale (InBody)
Time frame
2 weeks2
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Changes in waist circumference (centimeters, cm) measured using a flexible, non-stretchable measuring tape at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest.
Time frame
2 weeks3
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Changes in body fat percentage (%) as measured by bioelectrical impedance analysis (e.g., InBody).
Time frame
2 weeks4
To evaluate changes in weight, waist circumference, and body composition before and after dietary intervention.
Changes in skeletal muscle mass (kg) as measured by bioelectrical impedance analysis (e.g., InBody).
Time frame
2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov