Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Arizona

About 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

Qualifiers

≥ 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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Pulses 1.5 cups Group
  • Pulses 3 cups Group
  • My Plate Group (Control)

Treatment groups

180 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Arizona

Lead sponsor

United States Department of Agriculture (USDA)

Collaborator