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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
michael macknin, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01817491
First received: March 21, 2013
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Cardiovascular Disease
Hypercholesterolemia
Obesity
Fatty Liver
Other: American Heart Association Diet
Other: Reduced Fat Vegan Diet
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Biomarkers of cardiovascular risk [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Anthropometric measurements [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Height, Weight, BMI, Waist circumference, Blood pressure, Tanner staging


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Patients already on vegetarian diets
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817491

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

Publications:
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

Responsible Party: michael macknin, Professor of Pediatrics Cleveland Clinic Lerner College of Medicine of Case Western Reserve, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01817491     History of Changes
Other Study ID Numbers: 12-1298
Study First Received: March 21, 2013
Last Updated: September 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Vegan Diet
Hypercholesterolemia
American Heart Association Diet
Cardiovascular Risk
Obesity

Additional relevant MeSH terms:
Obesity
Cardiovascular Diseases
Hypercholesterolemia
Fatty Liver
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014