Source: UNIVERSITY OF ARIZONA submitted to
EFFECTS OF INCREASING PULSE CONSUMPTION ON CARDIOVASCULAR DISEASE RISK FACTORS: A RANDOMIZED CONTROLLED TRIAL
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
NEW
Funding Source
Reporting Frequency
Annual
Accession No.
1031980
Grant No.
2024-67017-42138
Project No.
ARZW-2023-07667
Proposal No.
2023-07667
Multistate No.
(N/A)
Program Code
A1811
Project Start Date
May 1, 2024
Project End Date
Apr 30, 2027
Grant Year
2024
Project Director
Skulas-Ray, A.
Recipient Organization
UNIVERSITY OF ARIZONA
888 N EUCLID AVE
TUCSON,AZ 85719-4824
Performing Department
(N/A)
Non Technical Summary
Approximately 60% of U.S. adults have one chronic disease and 40% have two or more, including diet-related health conditions like cardiovascular disease (CVD), the leading cause of death in the United States. The Dietary Guidelines for Americans (DGA) recommend a dietary pattern that includes 1.5 cup-equivalents/week of pulses for health promotion and chronic disease risk reduction. Yet, research demonstrates that a higher intake of pulses - nutrient-dense foods that provide numerous under-consumed nutrients (e.g., fiber, iron, folate, and potassium) - may be beneficial for the improvement of CVD risk factors. Thus, the proposed project aims to compare the impact of two weekly doses of pulses - 1.5 cups/week and 3 cups/week - on CVD risk factors and diet quality in a parallel-arm trial. One hundred eighty adults representative of the U.S. population (aged 18-65 years) will be randomized to a control group or an intervention group including 1.5 cups/week or 3 cups/week into their habitual dietary pattern for 12 weeks. All intervention groups will take part in bi-weekly cooking classes and food demonstrations. At baseline and following each 12-week period, dietary intake, lipids, glucose, hs-CRP, blood pressure, body weight, and diet satisfaction will be assessed. We predict that adding pulses to the diet will lead to better heart health and improved diet quality, as well as greater satisfaction with life. This research will provide valuable information about the health benefits of pulses and may influence future dietary guidance if there is evidence to increase the recommended amount of pulses in the Dietary Guidelines for Americans.
Animal Health Component
0%
Research Effort Categories
Basic
(N/A)
Applied
100%
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
72414191010100%
Goals / Objectives
The major goal of this project is to determine whether a higher intake of pulses is beneficial for the improvement of cardiovascular disease risk factors and overall diet quality and diet satisfaction. Results from this project will help to inform dietary guidance and whether there is justification to increase the recommended serving of pulses in future iterations of the Dietary Guidelines for Americans.Objectives:Recruit and enroll a total of 180 participants (n = 60 per group; Control, Pulses [1.5 cups per week], and Pulses Plus [3 cups per week]) over the course of the studyMeasure the standard lipid panel (LDL-C, HDL-C, total cholesterol, triglycerides, non-HDL-C), HbA1c, and CRP in all participants to determine the effect of pulse supplementation and doseDetermine the effect of pulse supplementation on both brachial and central blood pressureAssess participants' satisfaction with life, satisfaction with food-related life, and physical activity to determine the impact of nutrition education and/or pulse supplementationPerform dietary assessments (consisting of 3-day 24-hour dietary recalls) on all participants at baseline and post-intervention to assess dietary quality (as measured by the Healthy Eating Index) and identify if/how supplemental pulses alter dietary intake
Project Methods
We will conduct a three-arm, randomized, controlled intervention study of parallel design. Participants will be randomized to 1) Pulses (1.5 cup-eq/wk), 2) Pulses Plus (3 cup-eq/wk), or 3) a control group for 12 weeks. All participants will undergo the same procedures except for the supplementation of pulses for the intervention groups (groups 1 and 2). A crossover design was considered such that participants would act as their own controls, minimizing external variables; however, due to concerns about carryover effects, a parallel design was selected. In addition, the length of the study was selected to align with the current approach to dietary guidance which focuses on dietary patterns. Inclusion criteria include adults without significant disease requiring clinical nutrition management (e.g., late-stage chronic kidney disease) who report consuming less than 1.5 cup-eq/week of pulses. This study will seek to enroll a total of 180 participants.All participants will attend biweekly cooking classes and food demonstrations at Tucson Village Farm, a working farm with a teaching kitchen where staff regularly provide direct education to community members related to growing and preparing food to support overall health. During the class, participants in the control group will receive nutrition education in alignment with standard MyPlate messages while participants in the pulse intervention groups will receive that information plus additional content and messages focused on pulses. At each class, a recipe, inspired by MyPlate, will be prepared and tasted by participants. Participants in the Pulses and Pulses Plus groups will receive a 2-week supply of pre-packaged pulses to take home with them at these classes. One-third of the pulses will be frozen, 1/3 will be canned (e.g., pinto beans, black beans), and 1/3 will be premade (e.g., hummus). This balance of pulse forms and products was selected to enhance acceptability and convenience and improve shelf-stability. The Healthy US-Style Dietary Pattern of the DGA recommends 1.5 cup-eq of pulses each week for a 2000-calorie level dietary pattern. Pulse doses will be adjusted for a participant's caloric needs.At baseline and following the 12-week intervention, we will perform blood sampling, measurement of blood pressure, questionnaires to assess satisfaction with life and food, and dietary assessments via 24-hour recalls to calculate diet quality. Due to the type of intervention, blinding will not be possible for most of the study team and participants; however, the study statistician will be blinded for all analyses.We have established a timeline of activities and key milestones to measure success and progress towards our expected outcomes/accomplishments. Over the three-year study period, we will recruit three cohorts of participants. This will ensure that we do not overwhelm the capacity of our teaching kitchen and accommodate their other scheduled activities. IRB approval and clinicaltrials.gov registration will occur over the first 2 months, followed by development of cooking class curriculum. We expect participant recruitment for cohort 1 to begin in Quarter 3 of Year 1. All participant interventions and data collection are projected to be completed in the beginning of Quarter 2 of Year 3, followed by data analysis and publication in the remainder of Year 3.