Pulses for Heart Health

Overseen By Milad Hasankhani

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: High pulse intake, Food allergies, others

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

Compensation: Varies

Number of Visits: 9

Duration: 12-14 weeks

180 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your healthcare provider.

Are dietary pulses safe for human consumption?

Research suggests that dietary pulses, such as beans, chickpeas, lentils, and peas, are generally safe for human consumption and may offer health benefits, including improved heart health and reduced risk of certain diseases. However, more high-quality studies are needed to confirm these benefits. ^{1 2 3 4 5}

How do pulses differ from other treatments for heart health?

Pulses, which include beans, chickpeas, lentils, and peas, are unique because they are a natural food source that can help lower cholesterol and improve heart health through their high fiber and protein content, unlike traditional medications that may target specific heart conditions. They also contain beneficial plant compounds that may contribute to their heart-protective effects. ^{2 4 5 6 7}

What is the purpose of this trial?

This randomized clinical trial aims to evaluate the effects of consuming two different doses of pulses (1.5 cups/week or 3 cups/week) in individuals with baseline intake below 1.5 cups/week, compared to a control group receiving standard nutrition education based on the United States Department of Agriculture's (USDA) My Plate guidelines. The main question the Pulses study aims to answer is: • What is the effect of increasing pulse consumption (in a dose-response manner) on specific cardiometabolic risk factors, including LDL-C, CRP, HBA1C, and blood pressure compared to standard nutrition education? For secondary outcomes, this study aims to answer the following: • Does increased pulse consumption improve the following: overall serum lipid profile (Total cholesterol (TC), HDL-C, Triglycerides (TG), diet quality (measured by the Healthy Eating Index), and participants self-reported satisfaction with life (SWLS) and Satisfaction with Food-related Life (SWFoL). All participants will attend biweekly classes and food demonstrations. The pulses groups will learn to prepare various pulse-based recipes, while the control group will receive guidance on preparing healthy meals following the USDA MyPlate recommendations.

Eligibility Criteria

This trial is for individuals who currently eat less than 1.5 cups of pulses per week and are interested in understanding how increasing pulse intake can affect heart health and other cardiometabolic risk factors.

Inclusion Criteria

Able to communicate in English and provide written informed consent

Currently consuming less than 1.5 cup-equivalents of pulses per week

Assessed as suitable to participate in a nutrition intervention by the study dietitian or primary healthcare provider

Exclusion Criteria

Individuals already consuming >150 minutes/week of pulse-based dietary programming or otherwise regularly meeting high pulse intake benchmarks at baseline

Patients with food allergies or intolerances that preclude the consumption of pulses

Individuals who have not received clearance from their healthcare provider to make significant dietary modifications

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Testing

Participants undergo baseline testing including blood draw, vital signs, and dietary assessment

1 week

1 visit (in-person)

Treatment

Participants receive nutrition education and attend biweekly cooking classes for 12-14 weeks

12-14 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in cardiometabolic risk factors and diet quality

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Pulses

Trial Overview The study tests the effects of consuming either 1.5 or 3 cups of pulses weekly, compared to following standard USDA My Plate nutrition guidelines, on heart disease risk factors like LDL cholesterol and blood pressure.

Participant Groups

Group I: Pulses 3 cups Group Experimental Treatment 1 Intervention

Participants will receive an increased dose of 3 cup-equivalents of pulses per week. Similar to the first arm, they will participate in personalized nutrition education sessions and attend biweekly cooking classes and food demonstrations, all specifically designed to support a higher intake of pulses.

Group II: Pulses 1.5 cups Group Experimental Treatment 1 Intervention

Participants will be prescribed a diet that integrates 1.5 cup-equivalents of pulses per week. They will receive tailored nutrition education, including one-on-one sessions with nutrition educators, focused on how to incorporate pulses into everyday meals. Biweekly cooking classes and food demonstrations will be provided to illustrate easy pulse-based recipes and methods of preparation.

Group III: My Plate Group (Control) Active Control 1 Intervention

Participants will continue with their habitual dietary practices without any prescribed increase in pulse consumption. This arm will receive general nutrition education sessions covering balanced dietary practices, but without any additional focus on pulse integration.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

References

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

Can pulses play a role in improving cardiometabolic health? Evidence from systematic reviews and meta-analyses. [2022]

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

Phytochemicals for health, the role of pulses. [2023]

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

Associations between Dietary Pulses Alone or with Other Legumes and Cardiometabolic Disease Outcomes: An Umbrella Review and Updated Systematic Review and Meta-analysis of Prospective Cohort Studies. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials. [2021]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Pulses and lipaemia, short- and long-term effect: potential in the prevention of cardiovascular disease. [2017]

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

Benefits of pulse consumption on metabolism and health: A systematic review of randomized controlled trials. [2020]