Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT06861153
Status
Recruiting
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Conditions

  • CRP
  • Cardiovascular (CV) Risk
  • HbA1c
  • Healthy Eating Index
  • Lipid Profile

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Pulses 1.5 cups Group — BEHAVIORAL
    Participants will receive 1.5 cup-equivalents of pulses per week.
  • Pulses 3 cups Group — BEHAVIORAL
    Participants will receive 3 cup-equivalents of pulses per week.
  • My Plate Group (Control) — BEHAVIORAL
    Participants will continue with their usual dietary practices, receiving no additional pulses. They are encouraged to follow My Plate general recommendations.

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Jun 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pulses 1.5 cups Group
    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.
  • Experimental: Pulses 3 cups Group
    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.
  • Active Comparator: My Plate Group (Control)
    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.

Primary Outcome Measure

Change in serum LDL cholesterol [ Time Frame: baseline, 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tucson Village FarmTucsonArizona85719
Elizabeth Sparks
[email protected]
(520) 626-5161
University of ArizonaTucsonArizona85721
Ken Wilund, PhD
[email protected]
217-419-4087
Ken Wilund (PRINCIPAL_INVESTIGATOR)

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