Pulse-Based Diet for Healthy Lifestyle

(PRODMED1 Trial)

Overseen By Moul Dey, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: South Dakota State University

Must not be taking: Probiotics, Long-term antibiotics

Disqualifiers: Cancer, Diabetes, Heart, Liver, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the benefits of a diet rich in pulses, such as beans and lentils, to determine its impact on health outcomes like blood sugar control and body composition. Participants will follow either a meat-based or a pulse-based USDA diet to compare their effects. The researchers aim to discover if a pulse-based diet can be as nutritious as a meat-based one while potentially offering additional health benefits. Individuals who are generally healthy, without special dietary needs, and willing to eat a vegetarian diet might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential health benefits of a pulse-based diet.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not be using probiotics, long-term antibiotics, or tobacco/drugs/alcohol, and you should be willing to abstain from certain nutritional supplements, alcohol, or non-study foods during the study.

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

Research shows that pulses, including beans, lentils, and peas, are nutrient-rich and beneficial for health. They contain low levels of methionine (an amino acid) and other substances that can lead to TMAO, which is linked to heart disease. Studies suggest that consuming pulses is associated with a lower risk of long-term health issues and may help reduce inflammation and improve metabolism.

Regarding safety, pulses are widely consumed and considered safe for most people. They provide an affordable and eco-friendly source of protein, rich in vitamins and minerals. Available data has not reported major negative effects from eating pulses. However, some individuals might experience gas or bloating, common with high-fiber foods like pulses. Overall, a diet high in pulses is safe and generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pulse-based diets because they offer a plant-based alternative to traditional animal protein diets for promoting a healthy lifestyle. Unlike typical meat-based diets, pulse-based diets use legumes like beans, lentils, and peas as their primary protein source. This approach not only supports heart health and weight management but is also more sustainable and environmentally friendly. The potential health benefits and positive environmental impact make this dietary intervention particularly promising.

What evidence suggests that this trial's treatments could be effective?

Research has shown that a diet rich in pulses, such as beans and lentils, offers several health benefits. It can lower total and LDL cholesterol, which are important for heart health. This trial will compare a pulse-protein-based dietary intervention with a meat-based dietary intervention. The pulse-based diet also improves the body's use of insulin, which is crucial for controlling blood sugar levels. Additionally, pulses are rich in nutrients and fiber, supporting weight management and overall health. These benefits make pulse-based diets a promising option for reducing the risk of long-term diseases and enhancing general well-being. ^{2 4 5 6 7}

Who Is on the Research Team?

Moul Dey, Ph.D.

Principal Investigator

South Dakota State University

Are You a Good Fit for This Trial?

This trial is for people aged 60 or older, weighing at least 110 lbs, with normal HbA1C levels indicating generally good health. Participants should be currently following a meat-based diet without special dietary requirements and willing to eat on-site meals and provide samples. All races and sexes are welcome.

Inclusion Criteria

I am 60 years or older and in good health.

Generally good health status based on one routine physical in the past 15 months, current health status

I mainly eat meat, have no special diet needs, and agree to follow the study's eating and testing plan.

Exclusion Criteria

I have a history of cancer, diabetes, heart, liver, or kidney diseases.

Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight

If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a pulse-protein-based or animal protein-based dietary intervention

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pulse-based USDA-diet

Trial Overview The study tests the effects of a pulse-protein-based diet compared to a traditional meat-based diet on various health markers in older adults. It aims to see if this plant-based diet can improve long-term health outcomes by analyzing around 500 different biomarkers.

How Is the Trial Designed?

Group I: Pulse based Experimental Treatment 1 Intervention

Pulse-protein-based dietary intervention

Group II: Meat based Experimental Treatment 1 Intervention

Animal protein-based dietary intervention

Who Is Running the Clinical Trial?

South Dakota State University

Lead Sponsor

Trials

21

Recruited

10,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408265/

Pulse consumption trends in the US in the context of 2025 ... The 2025–30 US Dietary Guidelines Advisory Committee has recommended moving pulses to the Protein Foods Group and listing them ahead of meat, ...

2. ars.usda.gov ars.usda.gov/research/project/?accnNo=445351

Pulse Crop Health Initiative Coordinate the implementation of the pulse health initiative for expanded pulse crops research in the areas of human health and nutrition.

3. withpower.com withpower.com/trial/phase-healthy-lifestyle-behaviors-9-2022-85802

Pulse-Based Diet for Healthy Lifestyle (PRODMED1 Trial) Research shows that a pulse-based diet can lower total and LDL cholesterol, improve insulin sensitivity, and help with weight management, which are beneficial ...

4. frontiersin.org frontiersin.org/journals/sustainable-food-systems/articles/10.3389/fsufs.2025.1667600/pdf

The impact of environmental and health messaging, pulse ... Introduction: Pulses deliver beneficial nutrient profiles together with low environmental impacts, yet pulse consumption in the US is below.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11377338/

Pulse crops: nutrient density, affordability, and environmental ... The present analyses show that pulses had low cost and low carbon footprint compared to other protein foods and provided low-cost protein (after ...

6. frontiersin.org frontiersin.org/articles/10.3389/fsufs.2025.1667600/full

The impact of environmental and health messaging, pulse ... Introduction: Pulses deliver beneficial nutrient profiles together with low environmental impacts, yet pulse consumption in the US is below ...

7. ars.usda.gov ars.usda.gov/research/project/?accnNo=445763

Project : USDA ARS In this project we will investigate how consuming differentially processed pulse-based food products compared to whole pulses and non-pulse control foods ...