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

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Hypercholesterolemia Obesity Fatty Liver Other: American Heart Association Diet Other: Reduced Fat Vegan Diet Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : March 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Anthropometric measurements [ Time Frame: 4 weeks ]
    Height, Weight, BMI, Waist circumference, Blood pressure, Tanner staging

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Patients already on vegetarian diets

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01817491

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Michael Macknin, MD The Cleveland Clinic

Esselstyn R. The Engine 2 Diet How It All Began. In Esselstyn R "The Engine 2 Diet". New York, Boston: Wellness Central Hachette Book Group, 2009:15-30

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: michael macknin, Professor of Pediatrics Cleveland Clinic Lerner College of Medicine of Case Western Reserve, The Cleveland Clinic Identifier: NCT01817491     History of Changes
Other Study ID Numbers: 12-1298
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013

Keywords provided by michael macknin, The Cleveland Clinic:
Vegan Diet
American Heart Association Diet
Cardiovascular Risk

Additional relevant MeSH terms:
Cardiovascular Diseases
Fatty Liver
Lipid Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases