Pulses: Optimizing Pulse Consumption for Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Change in serum LDL cholesterol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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
排除标准
- •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)
结局指标
主要结局
Change in serum LDL cholesterol
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Change in serum Total Cholesterol(baseline, 3 months)
- Change in Serum Triglyceride (TG)(baseline, 3 months)
- Change in serum High-Density Lipoprotein Cholesterol (HDL-C)(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)
- Change in Satisfaction with Food-related Life Score (SWFoL)(baseline, 3 months)
- Change in Physical Activity(baseline, 3 months)
- Change in Satisfaction with Life Score (SWLS)(baseline, 3 months)