Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01817491
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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 9-18 y.o. With Elevated Cholesterol: A Four Week Randomized Trial
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Body Mass Index BMI Percentile [baseline, 4 weeks]

2. Children Change in BMI Z Score [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) [baseline, 4 weeks]

4. Change in Weight [baseline, 4 weeks]

5. Change in Circumference [baseline, 4 weeks]

6. Change in PAQ (Physical Activity Questionnaire) [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 [baseline, 4 weeks]

8. Change in Glucose [baseline, 4 weeks]

9. Change in hsCRP (High-sensitivity C-reactive Protein) [baseline, 4 weeks]

10. Change in Liver Enzymes [baseline, 4 weeks]

11. Change in IL-6 (Interleukin-6) [baseline, 4 weeks]

12. Change in MPO (Myeloperoxidase) [baseline, 4 weeks]

13. Change in HgbA1c (Hemoglobin A1c) [baseline, 4 weeks]

14. Change in Insulin [baseline, 4 weeks]

Secondary Outcome Measures

1. PB/AHA - Adjusted Mean Difference BMI [Baseline, 4 weeks]

2. PB/AHA - Adjusted Mean Difference BMI Z Score Children [Baseline, 4 weeks]

3. PB/AHA - Adjusted Mean BP [Baseline, 4 weeks]

4. PB/AHA - Adjusted Mean Difference Weight [Baseline, 4 weeks]

5. PB/AHA - Adjusted Mean Difference Circumference [Baseline, 4 weeks]

6. PB/AHA - Adjusted Mean Difference PAQ Children [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 [Baseline, 4 weeks]

8. PB/AHA - Adjusted Mean Ratio Glucose [Baseline, 4 weeks]

9. PB/AHA - Adjusted Mean Ratio hsCRP [Baseline, 4 weeks]

10. PB/AHA - Adjusted Mean Ratio Liver Enzymes [Baseline, 4 weeks]

11. PB/AHA - Adjusted Mean Ratio IL-6 [Baseline, 4 weeks]

12. PB/AHA - Adjusted Mean Ratio MPO [Baseline, 4 weeks]

13. PB/AHA - Adjusted Mean Ratio HgbA1c [Baseline, 4 weeks]

14. PB/AHA - Adjusted Mean Ratio Insulin [Baseline, 4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 18 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Michael Macknin, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bhattacharyya T, Nicholls SJ, Topol EJ, Zhang R, Yang X, Schmitt D, Fu X, Shao M, Brennan DM, Ellis SG, Brennan ML, Allayee H, Lusis AJ, Hazen SL. Relationship of paraoxonase 1 (PON1) gene polymorphisms and functional activity with systemic oxidative stress and cardiovascular risk. JAMA. 2008 Mar 19;299(11):1265-76. doi: 10.1001/jama.299.11.1265.
• 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
• Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents; National Heart, Lung, and Blood Institute. Expert panel on integrated guidelines for cardiovascular health and risk reduction in children and adolescents: summary report. Pediatrics. 2011 Dec;128 Suppl 5:S213-56. doi: 10.1542/peds.2009-2107C. Epub 2011 Nov 14.
• Fraser GE. Vegetarian diets: what do we know of their effects on common chronic diseases? Am J Clin Nutr. 2009 May;89(5):1607S-1612S. doi: 10.3945/ajcn.2009.26736K. Epub 2009 Mar 25. Review. Erratum in: Am J Clin Nutr. 2009 Jul;90(1):248.
• Fung TT, Rimm EB, Spiegelman D, Rifai N, Tofler GH, Willett WC, Hu FB. Association between dietary patterns and plasma biomarkers of obesity and cardiovascular disease risk. Am J Clin Nutr. 2001 Jan;73(1):61-7.
• Hu FB. Plant-based foods and prevention of cardiovascular disease: an overview. Am J Clin Nutr. 2003 Sep;78(3 Suppl):544S-551S. doi: 10.1093/ajcn/78.3.544S. Review.
• Ley RE, Hamady M, Lozupone C, Turnbaugh PJ, Ramey RR, Bircher JS, Schlegel ML, Tucker TA, Schrenzel MD, Knight R, Gordon JI. Evolution of mammals and their gut microbes. Science. 2008 Jun 20;320(5883):1647-51. doi: 10.1126/science.1155725. Epub 2008 May 22. Erratum in: Science. 2008 Nov 21;322(5905):1188.
• Muegge BD, Kuczynski J, Knights D, Clemente JC, González A, Fontana L, Henrissat B, Knight R, Gordon JI. Diet drives convergence in gut microbiome functions across mammalian phylogeny and within humans. Science. 2011 May 20;332(6032):970-4. doi: 10.1126/science.1198719.
• Newby PK. Plant foods and plant-based diets: protective against childhood obesity? Am J Clin Nutr. 2009 May;89(5):1572S-1587S. doi: 10.3945/ajcn.2009.26736G. Epub 2009 Mar 25. Review.
• Olza J, Aguilera CM, Gil-Campos M, Leis R, Bueno G, Martínez-Jiménez MD, Valle M, Cañete R, Tojo R, Moreno LA, Gil A. Myeloperoxidase is an early biomarker of inflammation and cardiovascular risk in prepubertal obese children. Diabetes Care. 2012 Nov;35(11):2373-6. doi: 10.2337/dc12-0614. Epub 2012 Aug 21.
• Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. Erratum in: JAMA 1999 Apr 21;281(15):1380.
• Pignatelli P, Loffredo L, Martino F, Catasca E, Carnevale R, Zanoni C, Del Ben M, Antonini R, Basili S, Violi F. Myeloperoxidase overexpression in children with hypercholesterolemia. Atherosclerosis. 2009 Jul;205(1):239-43. doi: 10.1016/j.atherosclerosis.2008.10.025. Epub 2008 Nov 6.
• Rak K, Rader DJ. Cardiovascular disease: the diet-microbe morbid union. Nature. 2011 Apr 7;472(7341):40-1. doi: 10.1038/472040a.
• Tang WH, Wang Z, Cho L, Brennan DM, Hazen SL. Diminished global arginine bioavailability and increased arginine catabolism as metabolic profile of increased cardiovascular risk. J Am Coll Cardiol. 2009 Jun 2;53(22):2061-7. doi: 10.1016/j.jacc.2009.02.036.
• Turner-McGrievy GM, Barnard ND, Scialli AR. A two-year randomized weight loss trial comparing a vegan diet to a more moderate low-fat diet. Obesity (Silver Spring). 2007 Sep;15(9):2276-81.
• Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
• Wang Z, Tang WH, Cho L, Brennan DM, Hazen SL. Targeted metabolomic evaluation of arginine methylation and cardiovascular risks: potential mechanisms beyond nitric oxide synthase inhibition. Arterioscler Thromb Vasc Biol. 2009 Sep;29(9):1383-91. doi: 10.1161/ATVBAHA.109.185645. Epub 2009 Jun 18.
• Zhang ZJ. Systematic review on the association between F2-isoprostanes and cardiovascular disease. Ann Clin Biochem. 2013 Mar;50(Pt 2):108-14. doi: 10.1258/acb.2012.011263. Epub 2012 Sep 27. Review.
• Zimmer J, Lange B, Frick JS, Sauer H, Zimmermann K, Schwiertz A, Rusch K, Klosterhalfen S, Enck P. A vegan or vegetarian diet substantially alters the human colonic faecal microbiota. Eur J Clin Nutr. 2012 Jan;66(1):53-60. doi: 10.1038/ejcn.2011.141. Epub 2011 Aug 3.

• Responsible Party: michael macknin, Professor of Pediatrics Cleveland Clinic Lerner College of Medicine of Case Western Reserve, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01817491
• Other Study ID Numbers: 12-1298
• First Posted: Mar 25, 2013
• Last Update Posted: Jan 15, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by michael macknin, Professor of Pediatrics Cleveland Clinic Lerner College of Medicine of Case Western Reserve, The Cleveland Clinic: Vegan Diet; Hypercholesterolemia; American Heart Association Diet; Cardiovascular Risk; Obesity
• Additional relevant MeSH terms: Fatty Liver; Cardiovascular Diseases; Hypercholesterolemia

Study Results

Participant Flow

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Period Title: Overall Study
STARTED	32	28
COMPLETED	28	28
NOT COMPLETED	4	0

Baseline Characteristics

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet	Total
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet	Total of all reporting groups
Overall Participants	32	28	60
Age (Count of Participants)
<=18 years	16 50%	14 50%	30 50%
Between 18 and 65 years	16 50%	14 50%	30 50%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Adolescents	15	15	15
Parents	46.5	46.0	46.25
Sex: Female, Male (Count of Participants)
Female	21 65.6%	19 67.9%	40 66.7%
Male	11 34.4%	9 32.1%	20 33.3%
Region of Enrollment (participants) [Number]
United States	32 100%	28 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Change in Body Mass Index BMI Percentile
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children only

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children	-1.12 (1.69)	-0.08 (0.42)
Parents	-1.29 (1.14)	-0.73 (0.92)

2. Primary Outcome

Title	Children Change in BMI Z Score
Description	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.
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children only

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	14	14
Mean (Standard Deviation) [Z Score]	-0.14 (0.16)	-0.03 (0.07)

3. Primary Outcome

Title	Change in Blood Pressure (BP)
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children Systolic BP	-6.43 (8.86)	-5.14 (17.64)
Parents Systolic BP	-7.96 (12.28)	-3.14 (14.42)
Children Diastolic BP	-2.61 (10.25)	-4.36 (14.67)
Parent Diastolic BP	-3.46 (11.06)	-6.64 (12.19)

4. Primary Outcome

Title	Change in Weight
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children	-3.05 (3.27)	-1.55 (1.83)
Parents	-3.64 (3.41)	-2.01 (2.66)

5. Primary Outcome

Title	Change in Circumference
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children Waist Circumference	-1.53 (3.01)	-2.96 (4.04)
Parents Waist Circumference	-1.94 (5.80)	-0.49 (5.73)
Children Midarm Circumference	-2.02 (2.17)	-1.14 (1.63)
Parents Midarm Circumference	-1.32 (2.06)	0.35 (3.16)

6. Primary Outcome

Title	Change in PAQ (Physical Activity Questionnaire)
Description	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.
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	0.22 (0.53)	-0.16 (0.54)

7. Primary Outcome

Title	Change in Lipid Profile
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
total cholesterol children	-22.50 (36.31)	-16.50 (28.19)
triglycerides children	-25.50 (95.26)	-13.14 (36.19)
high-density lipoprotein cholesterol children	-5.93 (9.37)	-2.93 (3.71)
low-density lipoprotein cholesterol children	-13.14 (35.54)	-11.00 (23.31)
total cholesterol parents	-33.79 (30.84)	-7.14 (24.93)
triglycerides parents	6.21 (41.71)	16.86 (36.86)
high-density lipoprotein cholesterol parents	-8.14 (41.71)	16.86 (36.86)
low-density lipoprotein cholesterol parents	-27.00 (26.72)	-5.50 (20.89)

8. Primary Outcome

Title	Change in Glucose
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children	0.93 (6.01)	-.64 (5.02)
Parent	4.93 (24.65)	-5.43 (12.40)

9. Primary Outcome

Title	Change in hsCRP (High-sensitivity C-reactive Protein)
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children	-2.09 (7.10)	2.78 (8.76)
Parent	-0.24 (1.36)	0.21 (1.90)

10. Primary Outcome

Title	Change in Liver Enzymes
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
alanine aminotransferase (ALT) children	0.79 (14.35)	-1.14 (3.46)
aspartate aminotransferase (AST) children	2.79 (8.96)	0.00 (4.69)
alanine aminotransferase (ALT) parents	0.86 (7.01)	4.57 (9.69)
aspartate aminotransferase (AST) parents	0.14 (5.70)	4.43 (6.73)

11. Primary Outcome

Title	Change in IL-6 (Interleukin-6)
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children	-0.17 (0.89)	-0.19 (3.14)
Parent	0.16 (0.90)	-0.19 (0.85)

12. Primary Outcome

Title	Change in MPO (Myeloperoxidase)
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children	-75.34 (37.34)	-69.23 (72.92)
Parent	16.91 (110.66)	1.78 (45.93)

13. Primary Outcome

Title	Change in HgbA1c (Hemoglobin A1c)
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children	0.17 (0.17)	0.21 (0.12)
Parent	-0.16 (0.16)	0.14 (0.49)

14. Primary Outcome

Title	Change in Insulin
Time Frame	baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	Reduced Fat Vegan Diet	American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet	Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
Measure Participants	28	28
Children	-5.42 (5.68)	3.16 (25.62)
Parents	-3.11 (8.56)	-3.15 (5.47)

15. Secondary Outcome

Title	PB/AHA - Adjusted Mean Difference BMI
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children Change in BMI	-1.17
Parents Change in BMI	-0.69

16. Secondary Outcome

Title	PB/AHA - Adjusted Mean Difference BMI Z Score Children
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	28
Mean (95% Confidence Interval) [Z score]	-0.13

17. Secondary Outcome

Title	PB/AHA - Adjusted Mean BP
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children adj mean ratio systolic BP	1.87
Children adj mean ratio diastolic BP	1.01
parents adj mean ratio systolic BP	0.97
parents adj mean ratio diastolic BP	1.03

18. Secondary Outcome

Title	PB/AHA - Adjusted Mean Difference Weight
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children Weight	-1.71
Parents Weight	-1.95

19. Secondary Outcome

Title	PB/AHA - Adjusted Mean Difference Circumference
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
children waist circumference	1.32
parents waist circumference	-1.14
children arm circumference	-1.25
parents arm circumference	-1.68

20. Secondary Outcome

Title	PB/AHA - Adjusted Mean Difference PAQ Children
Description	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.
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	28
Mean (95% Confidence Interval) [units on a scale]	0.39

21. Secondary Outcome

Title	PB/AHA - Adjusted Mean Lipid Profile
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
CHOL children	-10.34
TRIG children	1.01
HDL children	0.17
LDL children	0.95
CHOL parents	-27.29
TRIG parents	0.95
HDL parents	0.94
LDL parents	-21.92

22. Secondary Outcome

Title	PB/AHA - Adjusted Mean Ratio Glucose
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children	1.01
Parents	1.06

23. Secondary Outcome

Title	PB/AHA - Adjusted Mean Ratio hsCRP
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children	0.46
Parents	0.68

24. Secondary Outcome

Title	PB/AHA - Adjusted Mean Ratio Liver Enzymes
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
ALT children	1
AST children	1.13
ALT parents	0.85
AST parents	0.83

25. Secondary Outcome

Title	PB/AHA - Adjusted Mean Ratio IL-6
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children	0.26
Parents	1.14

26. Secondary Outcome

Title	PB/AHA - Adjusted Mean Ratio MPO
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children	0.95
Parents	0.93

27. Secondary Outcome

Title	PB/AHA - Adjusted Mean Ratio HgbA1c
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children	0.99
Parents	0.96

28. Secondary Outcome

Title	PB/AHA - Adjusted Mean Ratio Insulin
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Children and Parents

Arm/Group Title	PB/AHA
Arm/Group Description
Measure Participants	56
Children	0.7
Parents	0.87

Adverse Events

Arm/Group Title	Reduced Fat Vegan Diet		American Heart Association Diet
Arm/Group Description	Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet		Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
All Cause Mortality
	Reduced Fat Vegan Diet		American Heart Association Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Reduced Fat Vegan Diet		American Heart Association Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Reduced Fat Vegan Diet		American Heart Association Diet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.