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Completed

NCT Number: NCT01817491

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant women
  • Patients already on vegetarian diets

Treatment and study plan

American Heart Association Diet

Other

Reduced Fat Vegan Diet

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 25, 2013
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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