76 Participants Needed

Pulse-Based Diet for Healthy Lifestyle

(PRODMED1 Trial)

MD
Overseen ByMoul Dey, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: South Dakota State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.26789

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.123610

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

MD

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.
See 1 more

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
See 7 more

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
2Treatment groups
Experimental Treatment
Group I: Pulse basedExperimental Treatment1 Intervention
Pulse-protein-based dietary intervention
Group II: Meat basedExperimental Treatment1 Intervention
Animal protein-based dietary intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

South Dakota State University

Lead Sponsor

Trials
21
Recruited
10,100+

References

A pulse-based diet is effective for reducing total and LDL-cholesterol in older adults. [2013]
Dietary guidance for pulses: the challenge and opportunity to be part of both the vegetable and protein food groups. [2018]
Pulse consumption, satiety, and weight management. [2023]
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]
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]
Terminology Matters: Advancing Science to Define an Optimal Pulse Intake. [2022]
Socio-Ecological Barriers to Dry Grain Pulse Consumption among Low-Income Women: A Mixed Methods Approach. [2019]
Enhancing nutrition with pulses: defining a recommended serving size for adults. [2022]
Pulse Intake Improves Nutrient Density among US Adult Consumers. [2021]
Nutritional and health benefits of pulses. [2023]
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