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

NCT01817491 | Completed Results DMC

• 1 other identifier: 12-1298
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Hypercholesterolemia; Obesity; Fatty Liver

Keywords

Vegan Diet; Hypercholesterolemia; American Heart Association Diet; Cardiovascular Risk; Obesity

Outcome Measures

Primary Outcomes (14)

• Change in Body Mass Index BMI Percentile

  baseline, 4 weeks

• Children Change in BMI Z Score

  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.

  baseline, 4 weeks

• Change in Blood Pressure (BP)

  baseline, 4 weeks

• Change in Weight

  baseline, 4 weeks

• Change in Circumference

  baseline, 4 weeks

• Change in PAQ (Physical Activity Questionnaire)

  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.

  baseline, 4 weeks

• Change in Lipid Profile

  baseline, 4 weeks

• Change in Glucose

  baseline, 4 weeks

• Change in hsCRP (High-sensitivity C-reactive Protein)

  baseline, 4 weeks

• Change in Liver Enzymes

  baseline, 4 weeks

• Change in IL-6 (Interleukin-6)

  baseline, 4 weeks

• Change in MPO (Myeloperoxidase)

  baseline, 4 weeks

• Change in HgbA1c (Hemoglobin A1c)

  baseline, 4 weeks

• Change in Insulin

  baseline, 4 weeks

Secondary Outcomes (14)

• PB/AHA - Adjusted Mean Difference BMI

  Baseline, 4 weeks

• PB/AHA - Adjusted Mean Difference BMI Z Score Children

  Baseline, 4 weeks

• PB/AHA - Adjusted Mean BP

  Baseline, 4 weeks

• PB/AHA - Adjusted Mean Difference Weight

  Baseline, 4 weeks

• PB/AHA - Adjusted Mean Difference Circumference

  Baseline, 4 weeks

Study Arms (2)

Reduced Fat Vegan Diet

ACTIVE COMPARATOR

Plant based diet with as few added oils and fats as possible.

Other: Reduced Fat Vegan Diet

American Heart Association Diet

ACTIVE COMPARATOR

Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.

Other: American Heart Association Diet

Interventions

American Heart Association Diet OTHER

American Heart Association Diet

Reduced Fat Vegan Diet OTHER

Reduced Fat Vegan Diet

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant women
• Patients already on vegetarian diets

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (20)

• 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(Suppl 5):S213-56. doi: 10.1542/peds.2009-2107C. Epub 2011 Nov 14. No abstract available.

  PMID: 22084329 BACKGROUND

• Olza J, Aguilera CM, Gil-Campos M, Leis R, Bueno G, Martinez-Jimenez MD, Valle M, Canete 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.

  PMID: 22912422 BACKGROUND

• 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.

  PMID: 19081093 BACKGROUND

• 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.

  PMID: 21475195 BACKGROUND

• 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.

  PMID: 19477356 BACKGROUND

• 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.

  PMID: 19542023 BACKGROUND

• 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.

  PMID: 18349088 BACKGROUND

• 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.

  PMID: 23019600 BACKGROUND

• 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. doi: 10.1093/ajcn/73.1.61.

  PMID: 11124751 BACKGROUND

• 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.

  PMID: 19321559 BACKGROUND

• 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. doi: 10.1038/oby.2007.270.

  PMID: 17890496 BACKGROUND

• 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.

  PMID: 12936948 BACKGROUND

• 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. doi: 10.1001/jama.280.23.2001.

  PMID: 9863851 BACKGROUND

• 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.

  PMID: 18497261 BACKGROUND

• Muegge BD, Kuczynski J, Knights D, Clemente JC, Gonzalez 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.

  PMID: 21596990 BACKGROUND

• 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.

  PMID: 21811294 BACKGROUND

• 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.

  PMID: 19321569 BACKGROUND

• Rak K, Rader DJ. Cardiovascular disease: the diet-microbe morbid union. Nature. 2011 Apr 7;472(7341):40-1. doi: 10.1038/472040a. No abstract available.

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• 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

  BACKGROUND

• Macknin M, Kong T, Weier A, Worley S, Tang AS, Alkhouri N, Golubic M. Plant-based, no-added-fat or American Heart Association diets: impact on cardiovascular risk in obese children with hypercholesterolemia and their parents. J Pediatr. 2015 Apr;166(4):953-9.e1-3. doi: 10.1016/j.jpeds.2014.12.058. Epub 2015 Feb 12.

  PMID: 25684089 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Obesity; Fatty Liver

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Michael Macknin, MD
• Organization: Cleveland Clinic

macknim@ccf.org

216 444-5512

Study Officials

• Michael Macknin, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics Cleveland Clinic Lerner College of Medicine of Case Western Reserve

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 25, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 15, 2021
• Results First Posted: June 8, 2018

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)