Recruiting

Pulses

Sponsor:

University of Arizona

Code:

NCT06861153

Conditions

Cardiovascular (CV) Risk

Healthy Eating Index

HbA1c

Lipid Profile

CRP

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Pulses 1.5 cups Group

Pulses 3 cups Group

My Plate Group (Control)

Study Details

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.

Conditions

Cardiovascular (CV) Risk

Healthy Eating Index

HbA1c

Lipid Profile

CRP

Study ID

NCT06861153

Start date

Jul 1, 2025

Status verified date

Jun, 2025

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Pulses 1.5 cups Group

Participants will receive 1.5 cup-equivalents of pulses per week.

Pulses 3 cups Group

Participants will receive 3 cup-equivalents of pulses per week.

My Plate Group (Control)

Participants will continue with their usual dietary practices, receiving no additional pulses. They are encouraged to follow My Plate general recommendations.

Primary outcome measure

  • Change in serum LDL cholesterol [ Time Frame: baseline, 3 months ]
  • Change in serum HbA1c [ Time Frame: baseline, 3 months ]
  • Change in Brachial Blood Pressure [ Time Frame: baseline, 3 months ]
  • Change in serum C-Reactive Protein (CRP) [ Time Frame: baseline, 3 months ]

Central Contacts and Locations

Central contacts

Kenneth Wilud, PhD

520-626-3718kwilund@arizona.edu

Milad Hasankhani

5208525064miladh@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Ken Wilund, PhD

217-419-4087kwilund@arizona.edu

Principal Investigator:

Ken Wilund

More Information

Sponsor

University of Arizona

Last update posted

Aug 19, 2025

Last verified

Jun, 2025

Keywords

  • pulses
  • pulse consumption
  • cardiometabolic health
  • dietary intervention
  • nutrition education
  • chronic disease prevention
  • healthy eating
  • dietary guidelines

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-08-19.