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

Primary Purpose

Cardiovascular Disease, Hypercholesterolemia, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
American Heart Association Diet
Reduced Fat Vegan Diet
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring Vegan Diet, Hypercholesterolemia, American Heart Association Diet, Cardiovascular Risk, Obesity

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  • Patients already on vegetarian diets

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Reduced Fat Vegan Diet

American Heart Association Diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Body Mass Index BMI Percentile
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.
Change in Blood Pressure (BP)
Change in Weight
Change in Circumference
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.
Change in Lipid Profile
Change in Glucose
Change in hsCRP (High-sensitivity C-reactive Protein)
Change in Liver Enzymes
Change in IL-6 (Interleukin-6)
Change in MPO (Myeloperoxidase)
Change in HgbA1c (Hemoglobin A1c)
Change in Insulin

Secondary Outcome Measures

PB/AHA - Adjusted Mean Difference BMI
PB/AHA - Adjusted Mean Difference BMI Z Score Children
PB/AHA - Adjusted Mean BP
PB/AHA - Adjusted Mean Difference Weight
PB/AHA - Adjusted Mean Difference Circumference
PB/AHA - Adjusted Mean Difference PAQ Children
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.
PB/AHA - Adjusted Mean Lipid Profile
PB/AHA - Adjusted Mean Ratio Glucose
PB/AHA - Adjusted Mean Ratio hsCRP
PB/AHA - Adjusted Mean Ratio Liver Enzymes
PB/AHA - Adjusted Mean Ratio IL-6
PB/AHA - Adjusted Mean Ratio MPO
PB/AHA - Adjusted Mean Ratio HgbA1c
PB/AHA - Adjusted Mean Ratio Insulin

Full Information

First Posted
March 21, 2013
Last Updated
January 13, 2021
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01817491
Brief Title
Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Hypercholesterolemia, Obesity, Fatty Liver
Keywords
Vegan Diet, Hypercholesterolemia, American Heart Association Diet, Cardiovascular Risk, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced Fat Vegan Diet
Arm Type
Active Comparator
Arm Description
Plant based diet with as few added oils and fats as possible.
Arm Title
American Heart Association Diet
Arm Type
Active Comparator
Arm Description
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
Intervention Type
Other
Intervention Name(s)
American Heart Association Diet
Intervention Type
Other
Intervention Name(s)
Reduced Fat Vegan Diet
Primary Outcome Measure Information:
Title
Change in Body Mass Index BMI Percentile
Time Frame
baseline, 4 weeks
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
Title
Change in Blood Pressure (BP)
Time Frame
baseline, 4 weeks
Title
Change in Weight
Time Frame
baseline, 4 weeks
Title
Change in Circumference
Time Frame
baseline, 4 weeks
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
Title
Change in Lipid Profile
Time Frame
baseline, 4 weeks
Title
Change in Glucose
Time Frame
baseline, 4 weeks
Title
Change in hsCRP (High-sensitivity C-reactive Protein)
Time Frame
baseline, 4 weeks
Title
Change in Liver Enzymes
Time Frame
baseline, 4 weeks
Title
Change in IL-6 (Interleukin-6)
Time Frame
baseline, 4 weeks
Title
Change in MPO (Myeloperoxidase)
Time Frame
baseline, 4 weeks
Title
Change in HgbA1c (Hemoglobin A1c)
Time Frame
baseline, 4 weeks
Title
Change in Insulin
Time Frame
baseline, 4 weeks
Secondary Outcome Measure Information:
Title
PB/AHA - Adjusted Mean Difference BMI
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Difference BMI Z Score Children
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean BP
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Difference Weight
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Difference Circumference
Time Frame
Baseline, 4 weeks
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
Title
PB/AHA - Adjusted Mean Lipid Profile
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Ratio Glucose
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Ratio hsCRP
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Ratio Liver Enzymes
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Ratio IL-6
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Ratio MPO
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Ratio HgbA1c
Time Frame
Baseline, 4 weeks
Title
PB/AHA - Adjusted Mean Ratio Insulin
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children ages 9-18 BMI > 95th percentile Hypercholesterolemia (>169 mg/dl) Exclusion Criteria: Pregnant women Patients already on vegetarian diets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Macknin, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol

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