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Completed

NCT Number: NCT05869929

Easy Peasy: 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.

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Key information

Conditions

Health Knowledge, Attitudes, Practice Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vegetables

Dietary Supplement

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

Primary outcomes

  1. LDL-C/non-HDL-C

    Time frame: 4-6 weeks

  2. Brachial and central blood pressure

    Time frame: 4-6 weeks

    systolic and diastolic pressures

Secondary outcomes

  1. Augmentation Index

    Time frame: 4-6 weeks

    augmentation index corrected for heart rate augmentation index corrected for heart rate

  2. Other lipids and lipoproteins

    Time frame: 4-6 weeks

    HDL-C, total cholesterol, and triglycerides

  3. Glucose

    Time frame: 4-6 weeks

    Fasting blood glucose

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

Health Effects of Supplementation With Vegetables

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 22, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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