CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
American Heart Association Diet +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01817491
NCT01817491N/ACompleted

Low Fat Vegan Diet or American Heart Association Diet, Impact on Biomarkers of Inflammation, Oxidative Stress and Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol: A Four Week Randomized Trial

The Cleveland Clinic·interventional·Posted Mar 25, 2013·Updated Jan 15, 2021

In Brief

A clinical study evaluating American Heart Association Diet and Reduced Fat Vegan Diet for Cardiovascular Disease and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2013
Enrollment StartMar 1, 2013
Primary CompletionMay 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.3 years ago

Interventions

American Heart Association Dietother

Reduced Fat Vegan Dietother