About 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 accepts healthy volunteersQualifiers
≥ 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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Pulses 1.5 cups Group
BehavioralParticipants will receive 1.5 cup-equivalents of pulses per week.
Pulses 3 cups Group
BehavioralParticipants will receive 3 cup-equivalents of pulses per week.
My Plate Group (Control)
BehavioralParticipants will continue with their usual dietary practices, receiving no additional pulses. They are encouraged to follow My Plate general recommendations.
Treatment groups
Trial outcomes
Primary outcomes
Change in serum LDL cholesterol
LDL cholesterol will be measured using a standard lipid panel. Blood samples will be collected after an overnight fast and analyzed using standardized laboratory methods. LDL cholesterol will be reported in mg/dL. Minimum Value: 0 mg/dL (theoretically, though not physiologically possible). Maximum value: No absolute upper limit, but values above 190 mg/dL are considered very high and associated with significant cardiovascular risk. Interpretation: \<100 mg/dL (Optimal, low risk). ≥190 mg/dL (Very high, significantly increased cardiovascular risk).
Change in serum HbA1c
HbA1c will be measured using standard laboratory methods (such as high-performance liquid chromatography or immunoassay) to assess the average blood glucose levels over the past 2-3 months. Blood samples will be collected at the specified time points. Minimum Value: 0% (theoretically, though not physiologically possible). Maximum Value: There is no absolute upper limit, but values above 15% are typically associated with severe uncontrolled diabetes. Interpretation: Normal: \<5.7%. Diabetes: ≥6.5% (diagnostic threshold for diabetes, confirmed by a repeat test). Diabetes: ≥6.5% (diagnostic threshold for diabetes, confirmed by a repeat test).
Change in Brachial Blood Pressure
Blood pressure will be measured using a standardized sphygmomanometer or an automated digital device. Measurements will be taken after the patient has been at rest for at least 5 minutes. Both systolic and diastolic blood pressures will be recorded in mmHg at specified time points. Minimum Value: 0 mmHg (theoretically, though not physiologically possible). Maximum Value: There is no absolute upper limit, but very high values, typically above 200/120 mmHg, represent hypertensive crisis and require immediate medical intervention. Interpretation: Normal: Systolic \<120mmHg, Diastolic \<80mmHg. Hypertension Above: Systolic 130-139mmHg, Diastolic: 80-89mmHg
Change in serum C-Reactive Protein (CRP)
CRP levels will be measured using a high-sensitivity CRP (hs-CRP) blood test to assess systemic inflammation. A decrease in CRP levels will indicate a reduction in inflammation, potentially reflecting treatment efficacy. Minimum Value: \<0.3 mg/L (considered normal). Maximum Value: \>10 mg/L (indicative of significant inflammation or infection). Interpretation: \<1 mg/L → Low risk of inflammation (cardiovascular risk assessment); \>10 mg/L → Suggests acute infection or chronic inflammatory disease.
Secondary outcomes
Change in serum Total Cholesterol
Total cholesterol levels will be measured through a fasting blood test to assess lipid profile changes. A decrease in total cholesterol levels may indicate improved lipid metabolism and reduced cardiovascular risk. Minimum Value: \<125 mg/dL (low cholesterol, potential nutritional deficiencies). Maximum Value: \>240 mg/dL (high cholesterol, increased cardiovascular risk)
Change in serum High-Density Lipoprotein Cholesterol (HDL-C)
HDL-C levels will be measured through a fasting blood test to assess changes in cardioprotective lipid levels. An increase in HDL-C is associated with a reduced risk of cardiovascular disease. Minimum Value: \<20 mg/dL (severely low, high cardiovascular risk). Maximum Value: \>100 mg/dL (uncommon, but very high levels may have unclear clinical significance)
Change in Serum Triglyceride (TG)
Triglyceride levels will be measured through a fasting blood test to assess lipid metabolism. A reduction in triglyceride levels may indicate improved cardiovascular and metabolic health. Minimum Value: \<30 mg/dL (low levels, potentially associated with malnutrition or metabolic conditions). Minimum Value: \<30 mg/dL (low levels, potentially associated with malnutrition or metabolic conditions)
Change in Diet Quality Score (Healthy Eating Index - HEI)
Diet quality will be assessed using the Healthy Eating Index (HEI-2015 or HEI-2020), which evaluates adherence to the Dietary Guidelines for Americans. A higher HEI score indicates better diet quality, associated with improved health outcomes. Minimum Value: 0 (poor diet quality, minimal adherence to dietary guidelines). Maximum Value: 100 (optimal diet quality, full adherence to dietary guidelines).
Sponsors and contacts
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University of Arizona
Lead sponsor
United States Department of Agriculture (USDA)
Collaborator