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Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol

NCT01817491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-15

Study results available
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Summary

The purpose of this study is to investigate the short-term effects of a reduced fat plant-based diet on biomarkers of inflammation, oxidative stress and cardiovascular risk. This plant-based diet consists of whole grains, fruits and vegetables and little amounts of nuts and seeds, with no limitations on the amount of food intake. Animal products are not allowed. The results of the plant-based diet will be compared with the diet recommended by American Heart Association. This diet also emphasizes fruits and vegetables, but allows healthy fats, low-fat meats, fish and low-fat dairy in moderation. The results of the study might be useful in understanding whether or not plant-based diets are protective against cardiovascular disease.

Conditions

Interventions

OTHER

American Heart Association Diet

OTHER

Reduced Fat Vegan Diet

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Michael Macknin, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-05-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01817491 on ClinicalTrials.gov