NCT06861153 Pulses: Optimizing Pulse Consumption for Cardiometabolic Health
| NCT ID | NCT06861153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arizona |
| Condition | Cardiovascular (CV) Risk |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-07-01 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06861153 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cardiovascular (CV) Risk. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06861153 currently recruiting?
Yes, NCT06861153 is actively recruiting participants. Contact the research team at kwilund@arizona.edu for enrollment information.
Where is the NCT06861153 trial being conducted?
This trial is being conducted at Tucson, United States, Tucson, United States.
Who is sponsoring the NCT06861153 clinical trial?
NCT06861153 is sponsored by University of Arizona. The trial plans to enroll 180 participants.