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

76 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the pulse-based USDA-diet treatment?

Research shows that a pulse-based diet can lower total and LDL cholesterol, improve insulin sensitivity, and help with weight management, which are beneficial for heart health and managing conditions like diabetes and obesity. ^{1 2 3 4 5}

Is a pulse-based diet safe for humans?

Pulses, which include beans, peas, lentils, and chickpeas, have been consumed safely for thousands of years and are rich in nutrients like protein, fiber, iron, and potassium. They are generally considered safe and beneficial for improving diet quality and managing weight, blood sugar, and heart health. ^{2 6 7 8 9}

How does the pulse-based USDA-diet treatment differ from other treatments for a healthy lifestyle?

The pulse-based USDA-diet is unique because it emphasizes the consumption of pulses, such as beans, peas, and lentils, which are rich in plant-based protein and fiber. This diet not only helps in weight management and reducing cholesterol levels but also supports sustainable food practices, making it distinct from other dietary treatments. ^{1 2 3 6 10}

What is the purpose of this trial?

This trial tests a plant-based diet rich in pulses to help older adults maintain muscle mass and improve health. The diet is low in certain compounds that can cause health issues, aiming to improve blood sugar levels, body composition, and overall health by supporting a healthy gut.

Research Team

Moul Dey, Ph.D.

Principal Investigator

South Dakota State University

Eligibility Criteria

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.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

A pulse-based diet is effective for reducing total and LDL-cholesterol in older adults. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary guidance for pulses: the challenge and opportunity to be part of both the vegetable and protein food groups. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Pulse consumption, satiety, and weight management. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of a Low Glycemic Index Pulse-Based Diet on Insulin Sensitivity, Insulin Resistance, Bone Resorption and Cardiovascular Risk Factors during Bed Rest. [2020]

5. England pubmed.ncbi.nlm.nih.gov

The role of a pulse-based diet on infertility measures and metabolic syndrome risk: protocol of a randomized clinical trial in women with polycystic ovary syndrome. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Terminology Matters: Advancing Science to Define an Optimal Pulse Intake. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Socio-Ecological Barriers to Dry Grain Pulse Consumption among Low-Income Women: A Mixed Methods Approach. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Enhancing nutrition with pulses: defining a recommended serving size for adults. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Pulse Intake Improves Nutrient Density among US Adult Consumers. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Nutritional and health benefits of pulses. [2023]