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

January 13, 2021 updated by: michael macknin, The Cleveland Clinic

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 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Scientific Question: In obese, hypercholesterolemic (>169 mg/dl) 9-18 year olds and one of their parents are biomarkers of inflammation, oxidative stress and cardiovascular risk significantly reduced after a randomized 4 week trial of a reduced fat, vegan diet, or the American Heart Association (AHA) diet (which also encourages fruits, vegetables and whole grains, but permits low fat meat and dairy, and fish)? Rationale: "Cardiovascular disease remains the leading cause of death in North Americans, but manifest disease in childhood and adolescence is rare. By contrast, risk factors and risk behaviors that accelerate the development of atherosclerosis begin in childhood, and there is increasing evidence that risk reduction delays progression toward clinical disease". Myeloperoxidase is an early biomarker of inflammation, oxidative stress and cardiovascular risk in prepubertal obese children and is over expressed in children with hypercholesterolemia. Trimethylamine N-oxide, global arginine bioavailability ratio, arginine methylation index, paraoxonase 1 gene, and F2-isoprostane are all also associated with future major adverse cardiovascular events. Studies have suggested that a low-fat, vegan diet is effective in promoting weight loss, lowering body mass index, improving lipoprotein profiles, insulin sensitivity and in preventing cardiovascular disease in overweight individuals. Vegetarian diets have been shown to not only prevent but also to reverse heart disease in adults. Dietary habits (e.g. vegan/vegetarian versus omnivore/carnivore) are associated with significant alterations in intestinal microbiota composition and function. The diet-microbe interaction may play a significant role in the cardiovascular protective effects of a vegan/vegetarian diet. One small report of 15 adults on a reduced fat, vegan "Engine 2 Diet" for four weeks reported decreases in mean total cholesterol from 197 mg/dl to 135 mg/dl and mean LDL cholesterol falling from 124 mg/dl to 74 mg/dl.

Innovation: This is the first randomized trial comparing a low fat vegan diet to the standard AHA diet. If one diet proves superior in this brief pilot study, future larger long term studies will be needed to clearly define the health implications of our results.

Methods: Obese hypercholesterolemic children ages 9-18 will be identified by reviewing medical records and recruited initially by letters. Child, parent/guardian pairs will be randomly assigned to either the reduced fat vegan diet or the AHA diet.

During the 4-week study, participants will be asked to attend a group teaching and cooking session once a week on Saturday to learn about their assigned diets. The participants will also be requested to record their diet history on 2 weekdays and 1 weekend day before and again during the 4 weeks of the study.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children ages 9-18
  • BMI > 95th percentile
  • Hypercholesterolemia (>169 mg/dl)

Exclusion Criteria:

  • Pregnant women
  • Patients already on vegetarian diets

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reduced Fat Vegan Diet
Plant based diet with as few added oils and fats as possible.
Other: Reduced Fat Vegan Diet
Active Comparator: American Heart Association Diet
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
Other: American Heart Association Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index BMI Percentile
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Children Change in BMI Z Score
Time Frame: baseline, 4 weeks
Body mass index z-scores, also called BMI standard deviation (s.d.) scores, are measures of relative weight adjusted for child age and sex. Given a child's age, sex, BMI, and an appropriate reference standard, a BMI z-score (or its equivalent BMI-for-age percentile) can be determined. Negative BMI z-scores indicate a BMI that is lower than the population mean, while positive BMI scores indicate a value that is higher than the population mean. A decrease in the BMI z-score over time indicate a lowering of the BMI. Z-scores of 1.03 and 1.64 correspond to the 85th and 95th percentiles of BMI-for-age, which are the definitions of overweight and obesity in children.
baseline, 4 weeks
Change in Blood Pressure (BP)
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in Weight
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in Circumference
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in PAQ (Physical Activity Questionnaire)
Time Frame: baseline, 4 weeks
PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.
baseline, 4 weeks
Change in Lipid Profile
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in Glucose
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in hsCRP (High-sensitivity C-reactive Protein)
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in Liver Enzymes
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in IL-6 (Interleukin-6)
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in MPO (Myeloperoxidase)
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in HgbA1c (Hemoglobin A1c)
Time Frame: baseline, 4 weeks
baseline, 4 weeks
Change in Insulin
Time Frame: baseline, 4 weeks
baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PB/AHA - Adjusted Mean Difference BMI
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Difference BMI Z Score Children
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean BP
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Difference Weight
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Difference Circumference
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Difference PAQ Children
Time Frame: Baseline, 4 weeks
PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.
Baseline, 4 weeks
PB/AHA - Adjusted Mean Lipid Profile
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio Glucose
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio hsCRP
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio Liver Enzymes
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio IL-6
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio MPO
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio HgbA1c
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio Insulin
Time Frame: Baseline, 4 weeks
Baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Michael Macknin, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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