Pulses for Heart Health

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Arizona

No Placebo Group

Trial Summary

What is the purpose of 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

This trial is for individuals who currently eat less than 1.5 cups of pulses per week and are interested in understanding how increasing pulse intake can affect heart health and other cardiometabolic risk factors.

Participant Groups

The study tests the effects of consuming either 1.5 or 3 cups of pulses weekly, compared to following standard USDA My Plate nutrition guidelines, on heart disease risk factors like LDL cholesterol and blood pressure.

3Treatment groups

Experimental Treatment

Active Control

Group I: Pulses 3 cups GroupExperimental Treatment1 Intervention

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.

Group II: Pulses 1.5 cups GroupExperimental Treatment1 Intervention

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.

Group III: My Plate Group (Control)Active Control1 Intervention

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.