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

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ClinicalTrials.gov Identifier: NCT01817491
Recruitment Status : Completed
First Posted : March 25, 2013
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
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 Not Applicable

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)
Actual 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
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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. Change in Body Mass Index BMI Percentile [ Time Frame: baseline, 4 weeks ]
  2. Children Change in BMI Z Score [ Time Frame: baseline, 4 weeks ]
    Body mass index z-scores, also called BMI standard deviation (s.d.) scores, are measures of relative weight adjusted for child age and sex. Given a child's age, sex, BMI, and an appropriate reference standard, a BMI z-score (or its equivalent BMI-for-age percentile) can be determined. Negative BMI z-scores indicate a BMI that is lower than the population mean, while positive BMI scores indicate a value that is higher than the population mean. A decrease in the BMI z-score over time indicate a lowering of the BMI. Z-scores of 1.03 and 1.64 correspond to the 85th and 95th percentiles of BMI-for-age, which are the definitions of overweight and obesity in children.

  3. Change in Blood Pressure (BP) [ Time Frame: baseline, 4 weeks ]
  4. Change in Weight [ Time Frame: baseline, 4 weeks ]
  5. Change in Circumference [ Time Frame: baseline, 4 weeks ]
  6. Change in PAQ (Physical Activity Questionnaire) [ Time Frame: baseline, 4 weeks ]
    PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.

  7. Change in Lipid Profile [ Time Frame: baseline, 4 weeks ]
  8. Change in Glucose [ Time Frame: baseline, 4 weeks ]
  9. Change in hsCRP (High-sensitivity C-reactive Protein) [ Time Frame: baseline, 4 weeks ]
  10. Change in Liver Enzymes [ Time Frame: baseline, 4 weeks ]
  11. Change in IL-6 (Interleukin-6) [ Time Frame: baseline, 4 weeks ]
  12. Change in MPO (Myeloperoxidase) [ Time Frame: baseline, 4 weeks ]
  13. Change in HgbA1c (Hemoglobin A1c) [ Time Frame: baseline, 4 weeks ]
  14. Change in Insulin [ Time Frame: baseline, 4 weeks ]

Secondary Outcome Measures :
  1. PB/AHA - Adjusted Mean Difference BMI [ Time Frame: Baseline, 4 weeks ]
  2. PB/AHA - Adjusted Mean Difference BMI Z Score Children [ Time Frame: Baseline, 4 weeks ]
  3. PB/AHA - Adjusted Mean BP [ Time Frame: Baseline, 4 weeks ]
  4. PB/AHA - Adjusted Mean Difference Weight [ Time Frame: Baseline, 4 weeks ]
  5. PB/AHA - Adjusted Mean Difference Circumference [ Time Frame: Baseline, 4 weeks ]
  6. PB/AHA - Adjusted Mean Difference PAQ Children [ Time Frame: Baseline, 4 weeks ]
    PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.

  7. PB/AHA - Adjusted Mean Lipid Profile [ Time Frame: Baseline, 4 weeks ]
  8. PB/AHA - Adjusted Mean Ratio Glucose [ Time Frame: Baseline, 4 weeks ]
  9. PB/AHA - Adjusted Mean Ratio hsCRP [ Time Frame: Baseline, 4 weeks ]
  10. PB/AHA - Adjusted Mean Ratio Liver Enzymes [ Time Frame: Baseline, 4 weeks ]
  11. PB/AHA - Adjusted Mean Ratio IL-6 [ Time Frame: Baseline, 4 weeks ]
  12. PB/AHA - Adjusted Mean Ratio MPO [ Time Frame: Baseline, 4 weeks ]
  13. PB/AHA - Adjusted Mean Ratio HgbA1c [ Time Frame: Baseline, 4 weeks ]
  14. PB/AHA - Adjusted Mean Ratio Insulin [ Time Frame: Baseline, 4 weeks ]


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
Criteria

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 ClinicalTrials.gov identifier (NCT number): 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: March 25, 2013    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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