Pea Muffins for Blood Sugar and Appetite Control

(PEA3 Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Boniface Hospital

Must not be taking: Corticosteroids, Stomach acid-lowering, Laxatives, others

Disqualifiers: Diabetes, Cardiovascular disease, Liver disease, others

Compensation: Varies

Number of Visits: 4

Duration: Approximately 4-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how muffins made from peas affect blood sugar levels and hunger in healthy individuals. Participants will try muffins made from split peas and whole peas, comparing them to regular wheat muffins. The goal is to determine if pea muffins better control blood sugar and appetite than wheat muffins. Individuals who are generally healthy and regularly eat three meals a day may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative nutritional research that could influence future dietary guidelines.

Do I need to stop taking my current medications to join the trial?

The trial requires that you do not use any prescription or non-prescription drugs, herbal, or nutritional supplements that affect blood sugar or appetite. If you are taking such medications, you may need to stop them to participate.

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

Research shows that foods made from peas, such as muffins using split or whole peas, are generally safe for healthy individuals. Studies have found that these muffins can help manage blood sugar levels. For instance, one study found that people who ate foods with split peas experienced smaller increases in blood sugar. Another study suggested that pea protein might help protect against heart disease and diabetes.

Safety reports from these studies did not identify any major side effects, indicating that most people can consume split and whole pea muffins without problems. While a few individuals might experience minor digestive issues, the overall evidence supports the safety of these pea-based muffins for healthy adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using pea muffins for blood sugar and appetite control because they offer a natural, food-based approach, different from typical medications or supplements. Unlike standard treatments that often involve drugs to manage blood sugar levels, these muffins use whole and split yellow peas, which are rich in fiber and have a low glycemic index. This means they can help stabilize blood sugar without the need for additional medication. Additionally, the use of whole foods may also support long-term health benefits and be more appealing to those looking for dietary solutions.

What evidence suggests that this trial's treatments could be effective for blood sugar and appetite control?

This trial will compare the effects of different types of muffins on blood sugar and appetite control. Studies have shown that peas can help lower blood sugar levels. Participants in this trial may receive split pea muffins, which research indicates can reduce blood sugar by 6% to 11% compared to regular wheat-based muffins. Additionally, consuming foods like split peas can significantly lower blood sugar spikes after meals in both healthy individuals and those with type 2 diabetes. Whole pea muffins, another option in this trial, also control blood sugar better than wheat muffins. Both split and whole pea muffins show promise in managing blood sugar and enhancing feelings of fullness after eating. ^{1 2 3 6 7}

Who Is on the Research Team?

Heather Blewett, PhD

Principal Investigator

Agriculture and Agri-Food Canada

Are You a Good Fit for This Trial?

Healthy men and women aged 18-40, with a BMI of 18.5-30, who eat three meals daily can join this study on peas in muffins affecting blood sugar and fullness. Excluded are those with diabetes, abnormal cholesterol or triglycerides, recent major surgery, liver/kidney disease, cancer treatment within a year, shift workers, unstable weight or dieting individuals.

Inclusion Criteria

Body mass index (BMI) 18.5-30.0 kg/m2

Habitually consume breakfast, lunch and dinner in the morning, mid-day and evening, respectively

Willing to provide informed consent

Exclusion Criteria

Physical Activity Level >1.8

Pregnant or lactating

Fasting plasma HDL <0.9 mmol/L

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 4 clinic visits in a fasted state to consume muffins with and without peas and provide various samples and questionnaires

Approximately 4-8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for gastrointestinal side effects and calorie intake post-intervention

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Split Pea Muffins
• Wheat Muffins
• Whole Pea Muffins

Trial Overview The trial is testing how different types of muffins (split pea muffins vs wheat muffins vs whole pea muffins) affect post-meal blood sugar levels and feelings of fullness in healthy volunteers as part of research on the physical effects of peas.

How Is the Trial Designed?

Group I: whole yellow pea Experimental Treatment 1 Intervention

2 muffins containing 25g available carbohydrate from whole yellow peas. Intervention: Whole pea muffins

Group II: split yellow pea Experimental Treatment 1 Intervention

2 muffins containing 25g available carbohydrate from split yellow peas. Intervention: Split pea muffins

Group III: wheat-satiety Placebo Group 1 Intervention

2 muffins containing wheat flour to match the calories in the whole and split pea muffins. Intervention: Wheat muffins

Group IV: wheat-PPGR Placebo Group 1 Intervention

2 muffins containing 25g available carbohydrate from wheat flour. Intervention: Wheat muffins

Who Is Running the Clinical Trial?

St. Boniface Hospital

Lead Sponsor

Trials

55

Recruited

15,000+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

Agriculture and Agri-Food Canada

Collaborator

Trials

35

Recruited

2,300+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/76157?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Effect of Peas in Muffins on Blood Glucose and Appetite C... A randomized, controlled, cross-over study designed to examine the postprandial glycaemic response and appetite related sensations to peas ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8854292/

Pulse consumption improves indices of glycemic control in ... Pulse consumption significantly reduced acute post-prandial glucose concentration > 1 mmol/L in normoglycemic adults and > 2.5 mmol/L in those with T2D.

3. clinconnect.io clinconnect.io/trials/NCT03306706

Effect of Peas in Muffins on Blood Glucose and Appetite ClinConnect Summary. This clinical trial is investigating how including peas in muffins can affect blood sugar levels and feelings of fullness after eating.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02552823

NCT02552823 | Effects of Peas on Blood Glucose Control Peas are high in fibre and protein and show great potential as a functional food.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8997531/

Acute Effects of Split Pea-Enriched White Pan Bread on ... Although pea-containing bread samples (USYP, RT0%, and RT10%) showed 6% to 11% lower blood glucose iAUC values compared to the control wheat ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9412838/

The Current Situation of Pea Protein and Its Application in the ... The regular intake of food rich in pea protein helps to reduce the risk of cardiovascular diseases and diabetes. It may have protective effects ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1756464622001645

Health benefits of resistant starch: A review of the literature Consumption of muffins fortified with VERSAFIBE™ 247 by a group of healthy adult volunteers resulted in a 33% reduction in postprandial glycemia and an 8% ...