Optimizing pulse (beans, lentils, peas) intake for cardiometabolic health
Pulses: Optimizing Pulse Consumption for Cardiometabolic Health
NA · University of Arizona · NCT06861153
We will test whether eating 1.5 or 3 cups of pulses each week helps adults who currently eat less than 1.5 cups/week improve cholesterol, inflammation, blood sugar, and blood pressure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Arizona (other) |
| Locations | 2 sites (Tucson, Arizona and 1 other locations) |
| Trial ID | NCT06861153 on ClinicalTrials.gov |
What this trial studies
This is a randomized, parallel-arm trial that assigns adults with low baseline pulse intake to one of three groups: a MyPlate-based nutrition education control, a pulses 1.5 cups/week group, or a pulses 3.0 cups/week group. All groups attend six cooking classes and receive nutrition education, while the two intervention groups are provided with pulse servings to take home for 12–14 weeks. Primary outcomes include LDL-C, CRP, HbA1c, and blood pressure, with secondary outcomes covering full lipid profile, Healthy Eating Index, and measures of life and food satisfaction. Randomization is balanced by gender and conducted via REDCap at study sites in Tucson, Arizona.
Who should consider this trial
Good fit: Adults (age ≥18) who currently consume less than 1.5 cup-equivalents of pulses per week and are able to participate in a 12-week dietary program and in-person visits in Tucson, Arizona.
Not a fit: People who already consume high amounts of pulses, have pulse allergies or intolerances, or cannot make the required dietary changes are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could provide a simple, food-based approach to lower LDL cholesterol, reduce inflammation, and modestly improve blood sugar and blood pressure.
How similar studies have performed: Previous randomized trials and meta-analyses indicate pulses can lower LDL cholesterol and modestly improve glycemic control, but rigorous dose-response randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years old (with no upper age limit) * Currently consuming less than 1.5 cup-equivalents of pulses per week * Willing and able to participate in a 12-week dietary intervention focused on increased pulse consumption * Able to communicate in English and provide written informed consent * 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 * Participants anticipating major changes in dietary habits due to elective surgery, planned relocation, or other lifestyle alterations during the study period (12 weeks)
Where this trial is running
Tucson, Arizona and 1 other locations
- Tucson Village Farm — Tucson, Arizona, United States (NOT_YET_RECRUITING)
- University of Arizona — Tucson, Arizona, United States (RECRUITING)
Study contacts
- Study coordinator: Kenneth Wilud, PhD
- Email: kwilund@arizona.edu
- Phone: 520-626-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Risk, Healthy Eating Index, HbA1c, Lipid Profile, CRP, pulses, pulse consumption, cardiometabolic health