Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

NCT06861153 | Recruiting

• 1 other identifier: STUDY00004194
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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

  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.

  baseline, 3 months

Secondary Outcomes (7)

• Change in serum Total Cholesterol

  baseline, 3 months

• Change in serum High-Density Lipoprotein Cholesterol (HDL-C)

  baseline, 3 months

• Change in Serum Triglyceride (TG)

  baseline, 3 months

• Change in Diet Quality Score (Healthy Eating Index - HEI)

  baseline, 3 months

• Change in Satisfaction with Life Score (SWLS)

  baseline, 3 months

Study Arms (3)

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.

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.

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.

Interventions

Pulses 1.5 cups Group BEHAVIORAL

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

Pulses 1.5 cups Group

Pulses 3 cups Group BEHAVIORAL

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

Pulses 3 cups Group

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (2)

Tucson Village Farm

Tucson, Arizona, 85719, United States

NOT YET RECRUITING

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 19526214 BACKGROUND

• Jayalath 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.

  PMID: 24014659 BACKGROUND

• Ha 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.

  PMID: 24710915 BACKGROUND

• Ferreira 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.

  PMID: 31983216 BACKGROUND

• Mitchell 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.

  PMID: 34444828 BACKGROUND

Central Study Contacts

Kenneth Wilud, PhD

CONTACT

520-626-3718; kwilund@arizona.edu

Milad Hasankhani

CONTACT

5208525064; miladh@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-06

Locations

US (2)