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



Status:Completed
Conditions:High Cholesterol, Obesity Weight Loss, Peripheral Vascular Disease, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Gastroenterology
Healthy:No
Age Range:9 - 18
Updated:2/22/2019
Start Date:March 2013
End Date:December 2014

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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.

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.

Inclusion Criteria:

- Children ages 9-18

- BMI > 95th percentile

- Hypercholesterolemia (>169 mg/dl)

Exclusion Criteria:

- Pregnant women

- Patients already on vegetarian diets
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