Easy Peasy: Health Effects of Supplementation With Vegetables

Health Effects of Supplementation With Vegetables

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Dietary supplement: Vegetables

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vegetables; 4-5 servings of vegetables daily, per USDA definition.	Dietary supplement: Vegetables; 4-5 servings of vegetables daily, per USDA guidelines.
No Intervention: Normal diet; Participant maintains normal diet, no intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Ann Skulas-Ray, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Easy Peasy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No