38 Participants Needed

Royal Ancient Oats for Normal Blood Sugar

(RAO Trial)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how muffins made with Royal Ancient Oat Flour™ affect blood sugar levels compared to regular oat muffins. The goal is to determine if these special muffins can better manage blood sugar. Non-diabetic adults with stable weight for the past three months who are willing to avoid certain high-fiber and high-carb foods might be suitable candidates. Participants must follow guidelines about diet and supplements and consult with the study team before making changes. As an unphased trial, this study allows participants to contribute to innovative research on dietary impacts on blood sugar management.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that oat flour, like that used in Royal Ancient Oat Flour™, is generally safe for people. Safety information indicates that oat flour does not cause cancer and does not irritate the skin, though washing hands after handling it is advisable. The main caution is that it can irritate the eyes, so avoid contact. Additionally, oat flour can catch fire in dust form, so proper storage is important.

Overall, oat flour is well-tolerated and has been safely used in many products. Current research links no major health risks to its use.12345

Why are researchers excited about this trial?

Researchers are excited about Royal Ancient Oat Flour™ because it offers a natural approach to managing blood sugar levels, potentially reducing reliance on medications like metformin or insulin for diabetes. Unlike traditional treatments that directly alter insulin levels or sensitivity, this oat-based intervention might help stabilize blood sugar by improving digestion and absorption rates due to its high fiber content. Additionally, the treatment’s unique approach of using food, rather than pharmaceuticals, may appeal to those seeking more holistic or lifestyle-driven solutions.

What evidence suggests that Royal Ancient Oat Flour™ might be effective for glycemic control?

Research has shown that oats, including those with oat ß-glucan, can help control blood sugar levels. In studies with 110 participants, these oats lowered fasting insulin by 4.30 pmol/L, indicating better blood sugar control. Oats have also been found to lower blood sugar and other blood fats, aiding in weight and body fat management. The special compound in Royal Ancient Oats™, called avenanthramide, might offer unique benefits, though individuals may experience its effects differently. This trial will test Royal Ancient Oat Flour™ in different sequences of muffin consumption to evaluate its impact on blood sugar management. Overall, oats seem promising for improving how the body manages blood sugar levels.678910

Are You a Good Fit for This Trial?

The Royal Ancient Oats™ Study is for non-diabetic adults aged 35-65 with a BMI of 25-30. Participants must avoid high-fiber and high-carb foods, as well as certain supplements and medications that affect metabolism. They should not have had significant weight changes recently, be pregnant or drinking excessively, and must agree to follow the study's diet and supplement rules.

Inclusion Criteria

Participants must be able to adhere to the requirements of the study
Willing to limit/minimize foods that are rich sources of fiber and high carb content
I am not taking supplements or OTC meds that affect blood sugar.
See 3 more

Exclusion Criteria

Experienced weight loss or gain exceeding 5% of body weight in the past 3 months, including those involved in any weight loss or weight gain programs through diet and/or lifestyle changes
I am willing and able to follow my current medication and supplement regimen without changes.
I am currently on medication that affects my metabolism, like drugs for weight loss, blood pressure, or cholesterol.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Control Baseline

Participants consume regular flour (white wheat) muffins for three consecutive days as a baseline measure

1 week
1 visit (in-person)

Treatment

Participants are divided into two groups to consume either Royal Ancient Oats™ muffins or conventional oat muffins

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for changes in weight, waist circumference, and body composition after dietary intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Royal Ancient Oat Flour™

Trial Overview

This trial tests whether eating muffins made from a special oat flour (Royal Ancient Oats™) can help control blood sugar better than regular oat muffins in healthy individuals with normal blood sugar levels.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: B: Order of receiving muffins differsExperimental Treatment1 Intervention
Group II: A: Order of receiving muffins differsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Standard Process Inc.

Lead Sponsor

Trials
15
Recruited
680+

Citations

Study Details | NCT07371598 | Royal Ancient Oats™ Study

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 ...

Royal Ancient Oats™ Study | Clinical Research Trial ...

This study is a randomized, two-period crossover trial with a run-in control baseline and repeated measures, designed to evaluate the effects of ...

A Review of Health-Beneficial Properties of Oats - PMC

Effective reduction in body weight and fat and food efficiency but not appetite; reduction of serum glucose, free fatty acid, triacylglycerol ( ...

Effect of oats and oat ß-glucan on glycemic control in diabetes

In four trial comparisons involving 110 participants with a median study duration of 4.5 weeks, oats and oat ß-glucan reduced fasting insulin (MD, −4.30 pmol/L ...

A Randomized Controlled Trial to Assess the Feasibility ...

Individually perceived practicability was reported as good by 10/16 participants (62.5%). Total insulin dosage decreased from 138 ± 35 IU at ...

Oat Flour

Eye and Face Protection: Safety glasses or goggles. Skin and Body Protection: Wear suitable protective clothing if irritation is experienced.

organic whole oat flour - SAFETY DATA SHEET

Health Hazards: May cause eye irritation. Flammability Hazards: This product is considered a potential hazard for combustible dust.

SAFETY DATA SHEET

Oat flour is not listed by NTP, IARC or OSHA as a carcinogen/potential carcinogen. Reproductive Toxicity: Not classified; no data available.

SAFETY DATA SHEET TSK-BOT060 - Colloidal Oat Flour

TSK-BOT060 - Colloidal Oat Flour is not a skin irritant but wash skin thoroughly with soap and water as a precaution.

PRODUCTINFORMATION Oat flour Preliminary data sheet

The product complies with Danish and EU legislation. Produced without the use of GMO. GMO: OAT flour processed from dehulled cleaned and heat treated wholegrain ...