Easy Peasy: Health Effects of Supplementation With Vegetables

NCT05869929 | Completed

• 1 other identifier: Easy Peasy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (2)

• LDL-C/non-HDL-C

  4-6 weeks

• Brachial and central blood pressure

  systolic and diastolic pressures

  4-6 weeks

Secondary Outcomes (3)

• Augmentation Index

  4-6 weeks

• Other lipids and lipoproteins

  4-6 weeks

• Glucose

  4-6 weeks

Study Arms (2)

Vegetables

EXPERIMENTAL

4-5 servings of vegetables daily, per USDA definition.

Dietary Supplement: Vegetables

Normal diet

NO INTERVENTION

Participant maintains normal diet, no intervention

Interventions

Vegetables DIETARY_SUPPLEMENT

4-5 servings of vegetables daily, per USDA guidelines.

Vegetables

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Behavior

Interventions

Vegetables

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ann Skulas-Ray, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nutritional Sciences

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: May 22, 2023
• Study Start: February 15, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)