Plant-Based, American Heart Assoc. or Mediterranean Diets In 9-18 yo With BMI >95%, Cholesterol >169 and Their Parents

NCT02857543 | Completed

• 1 other identifier: 16-745
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to investigate the effects of a PB no- added-fat and the AHA and MED in obese (BMI \>95%) children ages 9-18 with hypercholesterolemia (\>169 mg/dl) and a parent or guardian. Eligible patients will be identified by utilizing the Pediatric Obesity Registry. When possible, in-person discussions or phone calls with their primary or tertiary care physicians will introduce eligible patients and their parents to the study. All eligible patients and parents will receive letters describing the study and requesting their participation. Subjects can choose not to participate in the study, and their health care will not be affected in any way. Subjects not participating will be asked if they are willing to answer a brief questionnaire about why they chose not to participate. The proposed study will be carried out for a total of 52 weeks. The investigators expect to recruit a total of 180 participants (30 children and 30 parents/guardians in each of the three groups). Each child and parent/guardian pair will be randomly assigned to either PB no-added-fat, AHA or MED.

Conditions

Obesity; Hypercholesterolemia; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline Biomarkers of Cardiovascular Risk at 4 weeks and 52 weeks

  Change in lipid panel, myeloperoxidase, hs C-reactive protein, insulin, glucose, HgbA1C, ALT, AST levels at 4 weeks and 52 weeks after baseline

  baseline, 4 weeks, 52 weeks

Secondary Outcomes (3)

• Change from baseline weight at 4 weeks and 52 weeks

  baseline, 4 weeks, 52 weeks

• Change from baseline blood pressure at 4 weeks and 52 weeks

  baseline, 4 weeks, 52 weeks

• Change in baseline waist circumference at 4 weeks and 52 weeks

  baseline, 4 weeks, 52 weeks

Study Arms (3)

plant-based diet

ACTIVE COMPARATOR

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

Other: Plant-Based Diet

American Heart Association

ACTIVE COMPARATOR

Diet encourages fruits, vegetables, whole grains, and low sodium intake but permits non-whole grains, low-fat dairy, selected plant oils, and lean meat and fish in moderation.

Other: American Heart Association Diet

Mediterranean

ACTIVE COMPARATOR

Diet encourages fruits, vegetables, whole grains, and low sodium intake but permits non-whole grains, low-fat dairy, selected plant oils, with more emphasis on fish and extra virgin olive oil and/or nuts.

Other: Mediterranean Diet

Interventions

Plant-Based Diet OTHER

plant-based diet

American Heart Association Diet OTHER

American Heart Association

Mediterranean Diet OTHER

Mediterranean

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
• obese (BMI \>95%)
• hypercholesterolemia (\>169 mg/dl)

You may not qualify if:

• pregnant women

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (12)

• Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.

  PMID: 16873779 BACKGROUND

• Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ, Glass J. The effects of a low-fat, plant-based dietary intervention on body weight, metabolism, and insulin sensitivity. Am J Med. 2005 Sep;118(9):991-7. doi: 10.1016/j.amjmed.2005.03.039.

  PMID: 16164885 BACKGROUND

• Ferdowsian HR, Barnard ND. Effects of plant-based diets on plasma lipids. Am J Cardiol. 2009 Oct 1;104(7):947-56. doi: 10.1016/j.amjcard.2009.05.032.

  PMID: 19766762 BACKGROUND

• Mishra S, Xu J, Agarwal U, Gonzales J, Levin S, Barnard ND. A multicenter randomized controlled trial of a plant-based nutrition program to reduce body weight and cardiovascular risk in the corporate setting: the GEICO study. Eur J Clin Nutr. 2013 Jul;67(7):718-24. doi: 10.1038/ejcn.2013.92. Epub 2013 May 22.

  PMID: 23695207 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

• 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

• 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

• Tuso PJ, Ismail MH, Ha BP, Bartolotto C. Nutritional update for physicians: plant-based diets. Perm J. 2013 Spring;17(2):61-6. doi: 10.7812/TPP/12-085.

  PMID: 23704846 BACKGROUND

• Esselstyn CB Jr, Gendy G, Doyle J, Golubic M, Roizen MF. A way to reverse CAD? J Fam Pract. 2014 Jul;63(7):356-364b.

  PMID: 25198208 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

• U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015-2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at http://health.gov/dietaryguidelines/2015/guidelines/

  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 BACKGROUND

MeSH Terms

Conditions

Obesity; Hypercholesterolemia; Cardiovascular Diseases

Interventions

Diet, Plant-Based; Diet, Mediterranean

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

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 CWRU, Cleveland Clinic

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: August 5, 2016
• Study Start: June 1, 2016
• Primary Completion: September 30, 2017
• Study Completion: October 25, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)