Pulses for Heart Health

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether increasing pulse consumption (such as beans and lentils) improves heart health by examining cholesterol, blood sugar, and blood pressure. Participants will be divided into groups to consume either 1.5 cups or 3 cups of pulses per week, or to follow general healthy eating guidelines without additional pulses. The study also aims to determine if increased pulse consumption enhances overall diet quality and life satisfaction. It is ideal for individuals who currently consume less than 1.5 cups of pulses per week and are willing to modify their diet for 12 weeks. As an unphased trial, this study provides a unique opportunity to contribute to nutritional research and potentially improve heart health and well-being.

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.

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

Research has shown that eating pulses, like beans and lentils, is generally safe for most people. Studies have found that pulses can lower the risk of heart disease. For instance, people who eat legumes four or more times a week have a 22% lower risk of heart disease compared to those who eat them less often.

Pulses are easy to digest and are part of heart-healthy diets. They can help improve cholesterol levels, which is important for heart health. These studies have not reported significant negative side effects from eating pulses, suggesting they are a safe addition to most diets.

For those considering joining a trial involving pulses, current evidence supports their safety and benefits in reducing heart disease risk factors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most heart health treatments focus on medications or lifestyle changes like exercise and reducing salt. But researchers are excited about using pulses, like beans and lentils, for heart health because they are a natural food source rich in fiber, proteins, and essential nutrients. Unlike other treatments, introducing pulses into the diet offers a straightforward, food-based approach that may improve heart health naturally without the need for pharmaceuticals. The "Pulses 1.5 cups Group" and "Pulses 3 cups Group" focus on different intake levels, allowing researchers to explore how varying amounts can influence heart health. This trial could reveal how something as simple as adding more pulses to your diet might be a game-changer for heart health.

What evidence suggests that increasing pulse consumption could be effective for improving cardiometabolic risk factors?

Research has shown that eating more pulses, such as beans and lentils, can lower the risk of heart disease. For instance, individuals who consume legumes four times a week have a 22% lower chance of developing heart disease compared to those who eat them less than once a week. One study found that high legume consumption is linked to a 6% lower overall risk of heart-related issues. While these findings are promising, the benefits appear strongest for those who consume the most legumes. This trial will compare different levels of pulse consumption: one group will consume 1.5 cup-equivalents of pulses per week, while another group will consume 3 cup-equivalents per week. Increasing pulse intake might also improve cholesterol levels and reduce inflammation, both important for heart health. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11937138/

Pulse and legume consumption is associated with a more ... Diets high in pulses and legumes have been associated with improved cardiovascular disease (CVD) risk markers but the relationship is less ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0939475322004185

Intake of legumes and cardiovascular disease The intake of legumes was associated with a reduced risk of CVD and CHD, but not with stroke, among individuals with the highest consumption levels.

3. nmcd-journal.com nmcd-journal.com/article/S0939-4753(22)00418-5/fulltext

Intake of legumes and cardiovascular disease The intake of legumes was associated with a reduced risk of CVD and CHD, but not with stroke, among individuals with the highest consumption levels.

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/649612

Legume Consumption and Risk of Coronary Heart Disease ... Legume consumption 4 times or more per week compared with less than once a week was associated with a 22% lower risk of CHD.

5. examine.com examine.com/research-feed/study/1PV4Z9/?srsltid=AfmBOopGJBaNXO-N9uZkHWbR2MI1G7cAXDz3lYU_eTK9X6VDATHJfsvm

Eating more legumes is associated with less heart disease A higher intake of legumes was associated with a 6% lower odds of CVD overall and a 4% lower risk of CVD in cohort studies specifically.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7566181/

The Role of Pulses in Cardiovascular Disease Risk for ... This evidence provides support for the consumption of pulses as an important dietary strategy to reduce risk of CVD for those living with and without diabetes.

7. heart.org heart.org/en/healthy-living/healthy-eating/eat-smart/nutrition-basics/the-benefits-of-beans-and-legumes

The Benefits of Beans and Legumes Eating beans as part of a heart healthy diet and lifestyle may help improve your blood cholesterol, a leading cause of heart disease.