Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID06861153

Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

Led by University of Arizona · Updated on 2025-08-19

180

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of Arizona

Lead Sponsor

U

United States Department of Agriculture (USDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how increasing pulse consumption affects cardiometabolic risk factors in adults who currently eat less than 1.5 cups of pulses per week. This study compares two different pulse intake levels—1.5 cups and 3 cups per week—against standard nutrition education based on the USDA's MyPlate guidelines. The primary focus is on changes in LDL cholesterol, C-reactive protein, HbA1c, and blood pressure, with additional interest in lipid profiles, diet quality, and life satisfaction measures. Participants are randomly assigned to one of three groups: a control group receiving general healthy eating education, a group receiving 1.5 cup-equivalents of pulses weekly along with targeted nutrition education, and a group receiving 3 cup-equivalents of pulses weekly with similar education. All groups attend biweekly cooking classes and food demonstrations over 12 to 14 weeks. Pulse doses are tailored to individual calorie needs and provided for participants to prepare and consume at home. Participants in pulse groups also complete weekly consumption logs. Throughout the study, participants undergo baseline and week-12 visits involving fasting blood draws to measure cardiometabolic biomarkers, blood pressure assessments under standardized conditions, and completion of questionnaires on diet and life satisfaction. Dietary intake is assessed using detailed 3-day food records at both timepoints. Physical activity is also monitored. Researchers track adverse events and medication changes. The study duration accommodates scheduling challenges by allowing intervention periods from 12 to 14 weeks.

CONDITIONS

Brief Title

Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • 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
Not Eligible

You will not qualify if you...

  • Currently consuming more than 150 minutes per week of pulse-based dietary programming or regularly meeting high pulse intake benchmarks
  • Having food allergies or intolerances that prevent consumption of pulses
  • Not having clearance from a healthcare provider to make significant dietary changes
  • Anticipating major changes in diet due to surgery, relocation, or lifestyle changes during the 12-week study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Online screening survey

Baseline Visit and Randomization

Duration - 1 day

Participants attend a baseline visit where informed consent is obtained, baseline assessments are completed, and participants are randomized to one of three diet groups. Assessments include blood draws, height, weight, vital signs, and questionnaires about diet and life satisfaction.

1 visit (in-person)

Dietary Intervention

Duration - 12 to 14 weeks

Participants attend biweekly cooking classes and receive nutrition education tailored to their assigned group. Those in the pulse groups receive weekly supplies of pulses to incorporate into their diet and complete weekly consumption logs. The intervention focuses on improving diet quality and increasing pulse intake over 12 to 14 weeks.

6 biweekly in-person cooking classes

Week 12 Endpoint Visit

Duration - 1 day

Participants complete endpoint assessments similar to baseline, including blood draws, vital signs, and questionnaires. Premenopausal women are scheduled to attend within the same menstrual cycle window as baseline. Dietary intake is also assessed with 3-day food records.

1 visit (in-person)

Trial Site Locations

Total: 2 locations

1

Tucson Village Farm

Tucson, Arizona, United States, 85719

Not Yet Recruiting

2

University of Arizona

Tucson, Arizona, United States, 85721

Actively Recruiting

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Research Team

K

Kenneth Wilud, PhD

M

Milad Hasankhani

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes.

J L Sievenpiper, C W C Kendall, A Esfahani...

https://pubmed.ncbi.nlm.nih.gov/19526214

Effect of dietary pulses on blood pressure: a systematic review and meta-analysis of controlled feeding trials.

Viranda H Jayalath, Russell J de Souza, John L Sievenpiper...

https://pubmed.ncbi.nlm.nih.gov/24014659

Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials.

Vanessa Ha, John L Sievenpiper, Russell J de Souza...

https://pubmed.ncbi.nlm.nih.gov/24710915