Easy Peasy: Health Effects of Supplementation With Vegetables

Study Overview
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Brief Summary
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The proposed study aims to test the effects of supplementing healthy individuals (with low baseline vegetable consumption) with 5 servings of vegetables (80-120g per serving) per day for 4 weeks on blood lipids and other cardiometabolic outcomes. Previous studies indicate the potential to see significant effects in this population and within this amount of time. Importantly, the investigators will also be including a weekly cooking demonstration as part of the intervention, which provides an essential hands-on participatory component and allows participants to connect with one another in a group setting, which aids in acceptability and adherence to dietary interventions. The investigators hypothesize that 4 weeks of daily supplementation with 4-5 servings of vegetables will significantly improve LDL-C and other cardiometabolic outcomes in healthy adults.

Official Title
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Health Effects of Supplementation With Vegetables

Conditions
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Health Knowledge, Attitudes, Practice

Intervention / Treatment
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* Dietary Supplement: Vegetables


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 18-65 years of age Consuming a typical American diet (i.e. not engaged in a structured diet) Willing and able to eat vegetables provided (i.e. not allergic or adverse to vegetables provided). Exclusion criteria: Pregnant or lactating Participants who currently eat 5+ servings/cups of vegetables per day (excluding tomato paste/sauce, and fried potatoes 'French fries') Any condition that would interfere with the participant's data, at the study team's discretion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegetables<br>4-5 servings of vegetables daily, per USDA definition. | Dietary Supplement: Vegetables<br>* 4-5 servings of vegetables daily, per USDA guidelines.<br>|
| No Intervention: Normal diet<br>Participant maintains normal diet, no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C/non-HDL-C |  | 4-6 weeks | 
| Brachial and central blood pressure | systolic and diastolic pressures | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Augmentation Index | augmentation index corrected for heart rate augmentation index corrected for heart rate | 4-6 weeks | 
| Other lipids and lipoproteins | HDL-C, total cholesterol, and triglycerides | 4-6 weeks | 
| Glucose | Fasting blood glucose | 4-6 weeks |