Easy Peasy: Health Effects of Supplementation With Vegetables

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

Health Effects of Supplementation With Vegetables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05869929
• Other study ID #: Easy Peasy
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: February 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Intervention

Dietary Supplement:
• Vegetables
4-5 servings of vegetables daily, per USDA guidelines.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C/non-HDL-C		4-6 weeks
Primary	Brachial and central blood pressure	systolic and diastolic pressures	4-6 weeks
Secondary	Augmentation Index	augmentation index corrected for heart rate augmentation index corrected for heart rate	4-6 weeks
Secondary	Other lipids and lipoproteins	HDL-C, total cholesterol, and triglycerides	4-6 weeks
Secondary	Glucose	Fasting blood glucose	4-6 weeks