RECRUITING

Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

Quick Facts

Study Start:2025-07-01
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06861153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years old (with no upper age limit)
  2. * Currently consuming less than 1.5 cup-equivalents of pulses per week
  3. * Willing and able to participate in a 12-week dietary intervention focused on increased pulse consumption
  4. * Able to communicate in English and provide written informed consent
  5. * Assessed as suitable to participate in a nutrition intervention by the study dietitian or primary healthcare provider
  1. * Individuals already consuming \>150 minutes/week of pulse-based dietary programming or otherwise regularly meeting high pulse intake benchmarks at baseline
  2. * Patients with food allergies or intolerances that preclude the consumption of pulses
  3. * Individuals who have not received clearance from their healthcare provider to make significant dietary modifications
  4. * Participants anticipating major changes in dietary habits due to elective surgery, planned relocation, or other lifestyle alterations during the study period (12 weeks)

Contacts and Locations

Study Contact

Kenneth Wilud, PhD
CONTACT
520-626-3718
kwilund@arizona.edu
Milad Hasankhani
CONTACT
5208525064
miladh@arizona.edu

Study Locations (Sites)

Tucson Village Farm
Tucson, Arizona, 85719
United States
University of Arizona
Tucson, Arizona, 85721
United States

Collaborators and Investigators

Sponsor: University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2028-09-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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