Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

Not Applicable

Not yet recruiting

• Conditions: Aldults Aged 18-75 Years That Eat Less Than 1.5 Cup-equivalents of Pulses Per Week and Cannot Have Significant Diseases Requiring Clinical Nutrition Management

• Registration Number: NCT06861153
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed Description

This is a randomized, parallel-arm study with 3 groups: 1) Control (Con). This group will receive educational materials and attend a series of 6 cooking classes focused on the USDA's MyPlate guidelines; 2) Pulses 1.5. This group receive nutrition education and attend a series of 6 cooking classes focused on both USDA's MyPlate guidelines, with a specific emphasis on how to incorporate more pulses into their diet. They will also receive 1.5 cup-equivalents of pulses per week for 6 weeks to take home with them to prepare and eat; 3) Pulses 3.0.

This group will receive the same nutrition education and cooking classes as the Pulses1.5 group, but will be provided with 3.0 cup equivalents of pulses to prepare and eat per week. Participants will be randomized after baseline testing. RedCap will be used to randomly assign participants to a treatment sequence. The randomization ratio will be balanced (balanced by gender and number of participants in each group). Intervention periods must be at least 12 weeks, however participants may continue the intervention for up to 14 weeks total (as is indicated in the informed consent). The range of 12-14 weeks is designed to accommodate for scheduling challenges that may occur due to illness, travel, etc. For example, if a participant completes 12 weeks of the intervention but then is unable to come in for an endpoint visit immediately, we will be able to continue the intervention until they are available for testing. The 12-14 week range will help to accommodate for these scheduling requirements.

Screening: Participants will be screened via an online REDCap survey including demographic and eligibility questions. Individuals who qualify for participation in the study will be invited to schedule a baseline testing visit in our nutrition research center.

Baseline and Week-12 Visits: At the baseline visit, participants will sign an IRB-approved informed consent form. At both visits, following an overnight fast, a blood draw will be completed, and height, weight, and vital signs will be determined. Premenopausal women will be asked to come in for endpoint visits at same point in their menstrual cycle (within the same 5-7 day window) as their baseline visit. In addition, participants will complete questionnaires to assess satisfaction with life and their diet.

* Blood Sampling: A fasting blood draw will be performed at each assessment to measure biomarkers of cardiometabolic health (including but not limited to): total cholesterol (TC), triglycerides (TG), HDL-C, LDL-C, HbA1c, and CRP. Values will be determined according to standardized procedures via Quest Diagnostics.

* Blood Pressure: Brachial blood pressure (BP) will be assessed under standardized conditions using an automated cuff. The BP measurements will be taken following the Joint National Committee 7 (JNC7) blood pressure guidelines in a quiet, temperature-controlled, dimly lit room following a 5-minute seated rest period, asking them not to use their phones, not to talk, and not to cross their legs. 3 measurements will be made, with 30 seconds rest in between, and the average will be calculated.

Questionnaires:

* Satisfaction with Food-related Life (SWFoL) scale: This scale consists of five items, grouped into a single dimension, that evaluate a person's overall assessment of their food and eating habits (e.g., "Food and meals bring great satisfaction to my daily life").

* Satisfaction with Life Scale (SWLS): This scale consists of five items, grouped into a single dimension, which evaluate overall cognitive judgments about a person's own life (e.g., "In most ways my life is close to my ideal").

* International Physical Activity Questionnaire (IPAQ): This questionnaire assesses the amount of time spent being physically active during the last seven days, grouped into vigorous, moderate, walking, and sitting categories.

Dietary Assessment: At baseline, participants will be instructed to maintain their regular caloric intake. At both baseline and at 12 weeks, participants will complete a 3 day dietary record to assess their dietary intake. At each timepoint (baseline and 12 weeks), dietary records will be conducted on 3 separate days to capture their average intake over a week. Baseline 3-day dietary records will be performed before the first cooking class to determine habitual dietary intake. The other records will be completed within a week of the week-12 visit. Diet quality will be calculated based on the nutrient intake data. NPCR program will be used to analyze the dietary intakes. HEI-2020 scores will be calculated to measure diet quality and assess alignment with the 2020-2025 DGA.

Dietary Intervention: All participants will attend biweekly cooking classes and food demonstrations at Tucson Village Farm (TVF), 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 MyPlate (control) group will receive nutrition education in alignment with standard MyPlate (i.e., a nutrition education tool for consumers based on the DGA) 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 will receive a 2-week supply of pulses to take home with them at these classes, one week of cooked, and one week of dry pulses. This balance of pulse forms was selected to enhance acceptability and convenience and improve self-stability. Participants in the Pulses1.5 and Pulses3.0 groups will also be asked to complete a weekly consumption log to track their consumption of the pulses that were provided at the cooking class. They will be asked to return this log at the following cooking class.

The Healthy US-Style Dietary Pattern of the DGA recommends 1.5 cup-eq of pulses each week for a 2000-calorie dietary pattern. Pulse doses will be adjusted for a participant's caloric needs. Each participant's caloric needs will be estimated using a mathematical formula. For example, a participant in the Pulses group who needs 1600 calories/day will receive 1 cup-eq of pulses each week and a participant who needs 3000 calories/day will receive 3 cup-eq of pulses each week. Similarly, a participant in the Pulses Plus group who needs 1600 calories/day will receive 2 cup-eq of pulses each week and a participant who needs 3000 calories/day will receive 6 cup-eq of pulses each week.

Any adverse events and/or changes in medication during the study will be recorded.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study Start: 2025-03-01
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2028-06-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• ≥ 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
• Assessed as suitable to participate in a nutrition intervention by the study dietitian or primary healthcare provider

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in serum LDL cholesterol	baseline, 3 months	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	baseline, 3 months	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	baseline, 3 months	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)	baseline, 3 months	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 Outcome Measures

Name	Time	Method
Change in serum Total Cholesterol	baseline, 3 months	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)	baseline, 3 months	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)	baseline, 3 months	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)	baseline, 3 months	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).
Change in Satisfaction with Life Score (SWLS)	baseline, 3 months	Life satisfaction will be assessed using the Satisfaction With Life Scale (SWLS), a validated 5-item questionnaire measuring subjective well-being. Higher scores indicate greater life satisfaction. Participants will rate each statement on a 7-point Likert scale, with total scores ranging from 5 to 35. Minimum Value: 5 (Extremely dissatisfied with life). Maximum Value: 35 (Extremely satisfied with life).
Change in Satisfaction with Food-related Life Score (SWFoL)	baseline, 3 months	Food-related life satisfaction will be assessed using the Satisfaction with Food-related Life (SWFoL) Scale, a validated 5-item questionnaire that evaluates an individual's overall satisfaction with food and eating experiences. Each item is rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree), with total scores ranging from 5 to 35. Higher scores indicate greater satisfaction with food-related life. Minimum Value: 5 (Very low satisfaction with food-related life). Maximum Value: 35 (Very high satisfaction with food-related life).

Trial Locations

Locations (1)

Tucson Village Farm; 🇺🇸 Tucson, Arizona, United States