Easy Peasy: Health Effects of Supplementation With Vegetables

NCT ID: NCT05869929

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-07-15

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.

Detailed Description

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Conditions

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Health Knowledge, Attitudes, Practice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vegetables

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

Group Type EXPERIMENTAL

Vegetables

Intervention Type DIETARY_SUPPLEMENT

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

Normal diet

Participant maintains normal diet, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vegetables

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

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Ann Skulas-Ray

Assistant Professor of Nutritional Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann Skulas-Ray, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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Easy Peasy

Identifier Type: -

Identifier Source: org_study_id

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