Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Arizona

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 volunteers

Qualifiers

≥ 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

Design model

Parallel

Treatments tested in this trial

  • Pulses 1.5 cups Group

    Behavioral

    Participants will receive 1.5 cup-equivalents of pulses per week.

  • Pulses 3 cups Group

    Behavioral

    Participants will receive 3 cup-equivalents of pulses per week.

  • My Plate Group (Control)

    Behavioral

    Participants will continue with their usual dietary practices, receiving no additional pulses. They are encouraged to follow My Plate general recommendations.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Pulses 1.5 cups GroupExperimental treatment 1 intervention
Group B: Pulses 3 cups GroupExperimental treatment 1 intervention
Group C: My Plate Group (Control)Active comparator 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
baseline, 3 months
2

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).

Time frame
baseline, 3 months
3

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

Time frame
baseline, 3 months
4

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.

Time frame
baseline, 3 months

Secondary outcomes

1

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)

Time frame
baseline, 3 months
2

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)

Time frame
baseline, 3 months
3

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)

Time frame
baseline, 3 months
4

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).

Time frame
baseline, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arizona

Lead sponsor

United States Department of Agriculture (USDA)

Collaborator