Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol
Condition: Cardiovascular Disease; Hypercholesterolemia; Obesity; Fatty Liver
MeSH terms: Fatty Liver; Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional

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.
    

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.
    

Intervention name(s): American Heart Association Diet; Reduced Fat Vegan Diet
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vegan Diet; Hypercholesterolemia; American Heart Association Diet; Cardiovascular Risk; Obesity