Low Fat Vegan Diet or American Heart Association Diet Impact on Cardiovascular Risk in Obese Hypercholesterolemic 9-18 y.o.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01817491
Recruitment Status : Unknown
Verified September 2013 by michael macknin, The Cleveland Clinic.
Recruitment status was:  Active, not recruiting
First Posted : March 25, 2013
Last Update Posted : September 20, 2013
Information provided by (Responsible Party):
michael macknin, The Cleveland Clinic

March 21, 2013
March 25, 2013
September 20, 2013
March 2013
May 2014   (Final data collection date for primary outcome measure)
Biomarkers of cardiovascular risk [ Time Frame: 4 weeks ]
Lipid panel, Myeloperoxidase, High-sensitive C-reactive protein, Insulin, Glucose,Hgb A1C, ALT, AST, IL6, Breath test - will measure 22 volatile organic compounds (possible fatty liver markers), Trimethylamine N-oxide, Global arginine bioavailability ratio, Arginine methylation index, Paraoxonase 1 gene, F2-isoprostane (urinary), intestinal microbiota
Same as current
Complete list of historical versions of study NCT01817491 on Archive Site
Anthropometric measurements [ Time Frame: 4 weeks ]
Height, Weight, BMI, Waist circumference, Blood pressure, Tanner staging
Same as current
Not Provided
Not Provided
Low Fat Vegan Diet or American Heart Association Diet Impact on Cardiovascular Risk in Obese Hypercholesterolemic 9-18 y.o.
Low Fat Vegan Diet or American Heart Association Diet, Impact on Biomarkers of Inflammation, Oxidative Stress and Cardiovascular Risk in Obese Hypercholesterolemic Children/Adolescents: 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.

Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Cardiovascular Disease
  • Hypercholesterolemia
  • Obesity
  • Fatty Liver
  • Other: American Heart Association Diet
  • Other: Reduced Fat Vegan Diet
  • Active Comparator: Reduced Fat Vegan Diet
    Plant based diet with as few added oils and fats as possible.
    Intervention: 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.
    Intervention: Other: American Heart Association Diet

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
May 2014
May 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Patients already on vegetarian diets
Sexes Eligible for Study: All
9 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
michael macknin, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Michael Macknin, MD The Cleveland Clinic
The Cleveland Clinic
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP