Cardiovascular (CV) RiskNCT06861153
Pulses: Optimizing Pulse Consumption for Cardiometabolic Health
A study testing Pulses 1.5 cups Group and Pulses 3 cups Group in people with Cardiovascular (CV) Risk and Healthy Eating Index, run by University of Arizona at 2 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular (CV) Risk, Healthy Eating Index, HbA1c
- What is being tested?
- Pulses 1.5 cups Group and Pulses 3 cups Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Tucson Village Farm
Tucson, Arizona, 85719
Elizabeth Sparks, (520) 626-5161, esparks@cals.arizona.edu
- Recruiting
University of Arizona
Tucson, Arizona, 85721
Ken Wilund, PhD, 217-419-4087, kwilund@arizona.edu
Ken Wilund
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Cardiovascular (CV) Risk, Healthy Eating Index, HbA1c, Lipid Profile, CRP
- Being tested
- Pulses 1.5 cups Group, Pulses 3 cups Group, My Plate Group (Control)
- Keywords
- pulses, pulse consumption, cardiometabolic health, dietary intervention, nutrition education, chronic disease prevention, healthy eating, dietary guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulses 1.5 cups GroupBehavioural
Participants will receive 1.5 cup-equivalents of pulses per week.
Pulses 3 cups GroupBehavioural
Participants will receive 3 cup-equivalents of pulses per week.
My Plate Group (Control)Behavioural
Participants will continue with their usual dietary practices, receiving no additional pulses. They are encouraged to follow My Plate general recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Pulses 1.5 cups Group | Experimental | 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. Receives: Behavioral: Pulses 1.5 cups Group |
| Pulses 3 cups Group | Experimental | 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. Receives: Behavioral: Pulses 3 cups Group |
| My Plate Group (Control) | Active comparator | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, 3 months
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).
Measured: baseline, 3 months
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
Measured: baseline, 3 months
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.
Measured: baseline, 3 months
Secondary outcomes (7)
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)
Measured: baseline, 3 months
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)
Measured: baseline, 3 months
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)
Measured: baseline, 3 months
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).
Measured: baseline, 3 months
Change in Satisfaction with Life Score (SWLS)
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).
Measured: baseline, 3 months
Change in Satisfaction with Food-related Life Score (SWFoL)
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).
Measured: baseline, 3 months
Change in Physical Activity
Physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). This validated self-report questionnaire captures the number of days and average duration per day participants engaged in vigorous activity, moderate activity, and walking over the past 7 days. It also collects data on sedentary time. Responses are converted to MET-minutes/week using IPAQ scoring protocols. Maximum value: High activity: ≥3,000 MET-min/week. Interpretation: Low activity: <600 MET-min/week, Moderate activity: ≥600 to <3,000 MET-min/week and High activity: ≥3,000 MET-min/week
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Jul 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular (CV) RiskStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861153
- Sponsor's protocol ID
- STUDY00004194
- Status last verified
- Jun 2025
- First submitted
- 28 Feb 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
PubMed 19526214Jayalath VH, de Souza RJ, Sievenpiper JL, Ha V, Chiavaroli L, Mirrahimi A, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulses on blood pressure: a systematic review and meta-analysis of controlled feeding trials. Am J Hypertens. 2014 Jan;27(1):56-64. doi: 10.1093/ajh/hpt155. Epub 2013 Sep 7.
PubMed 24014659Ha V, Sievenpiper JL, de Souza RJ, Jayalath VH, Mirrahimi A, Agarwal A, Chiavaroli L, Mejia SB, Sacks FM, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Bazinet RP, Josse RG, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials. CMAJ. 2014 May 13;186(8):E252-62. doi: 10.1503/cmaj.131727. Epub 2014 Apr 7.
PubMed 24710915Ferreira H, Vasconcelos M, Gil AM, Pinto E. Benefits of pulse consumption on metabolism and health: A systematic review of randomized controlled trials. Crit Rev Food Sci Nutr. 2021;61(1):85-96. doi: 10.1080/10408398.2020.1716680. Epub 2020 Jan 25.
PubMed 31983216Mitchell DC, Marinangeli CPF, Pigat S, Bompola F, Campbell J, Pan Y, Curran JM, Cai DJ, Jaconis SY, Rumney J. Pulse Intake Improves Nutrient Density among US Adult Consumers. Nutrients. 2021 Jul 31;13(8):2668. doi: 10.3390/nu13082668.
PubMed 34444828
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulses: Optimizing Pulse Consumption for Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT06861153
- Acronym / sponsor ID
- STUDY00004194
- Conditions
- Cardiovascular (CV) Risk, Healthy Eating Index, HbA1c, Lipid Profile, CRP
- Keywords
- pulses, pulse consumption, cardiometabolic health, dietary intervention, nutrition education, chronic disease prevention, healthy eating, dietary guidelines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulses 1.5 cups Group | Experimental | Behavioral: Pulses 1.5 cups GroupParticipants 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. |
| Pulses 3 cups Group | Experimental | Behavioral: Pulses 3 cups GroupParticipants 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. |
| My Plate Group (Control) | Active comparator | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulses 1.5 cups GroupParticipants will receive 1.5 cup-equivalents of pulses per week. | Behavioural | Pulses 1.5 cups Group |
| Pulses 3 cups GroupParticipants will receive 3 cup-equivalents of pulses per week. | Behavioural | Pulses 3 cups Group |
| My Plate Group (Control)Participants will continue with their usual dietary practices, receiving no additional pulses. They are encouraged to follow My Plate general recommendations. | Behavioural | – |
Primary outcome
Change in serum LDL cholesterol
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
7 secondary outcomes
Change in serum Total Cholesterol
Time frame: baseline, 3 months
Change in serum High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: baseline, 3 months
Change in Serum Triglyceride (TG)
Time frame: baseline, 3 months
Change in Diet Quality Score (Healthy Eating Index - HEI)
Time frame: baseline, 3 months
Change in Satisfaction with Life Score (SWLS)
Time frame: baseline, 3 months
Change in Satisfaction with Food-related Life Score (SWFoL)
Time frame: baseline, 3 months
Change in Physical Activity
Time frame: baseline, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Results publication: PubMed 19526214Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.
- Results publication: PubMed 24014659Jayalath VH, de Souza RJ, Sievenpiper JL, Ha V, Chiavaroli L, Mirrahimi A, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulses on blood pressure: a systematic review and meta-analysis of controlled feeding trials. Am J Hypertens. 2014 Jan;27(1):56-64. doi: 10.1093/ajh/hpt155. Epub 2013 Sep 7.
- Results publication: PubMed 24710915Ha V, Sievenpiper JL, de Souza RJ, Jayalath VH, Mirrahimi A, Agarwal A, Chiavaroli L, Mejia SB, Sacks FM, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Bazinet RP, Josse RG, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials. CMAJ. 2014 May 13;186(8):E252-62. doi: 10.1503/cmaj.131727. Epub 2014 Apr 7.
- Results publication: PubMed 31983216Ferreira H, Vasconcelos M, Gil AM, Pinto E. Benefits of pulse consumption on metabolism and health: A systematic review of randomized controlled trials. Crit Rev Food Sci Nutr. 2021;61(1):85-96. doi: 10.1080/10408398.2020.1716680. Epub 2020 Jan 25.
- Results publication: PubMed 34444828Mitchell DC, Marinangeli CPF, Pigat S, Bompola F, Campbell J, Pan Y, Curran JM, Cai DJ, Jaconis SY, Rumney J. Pulse Intake Improves Nutrient Density among US Adult Consumers. Nutrients. 2021 Jul 31;13(8):2668. doi: 10.3390/nu13082668.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulses 1.5 cups Group and Pulses 3 cups Group in people with Cardiovascular (CV) Risk and Healthy Eating Index, run by University of Arizona at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Wilud, PhD (520-626-3718, kwilund@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum LDL cholesterol (time frame: baseline, 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06861153, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.