Low Fat Vegan Diet or American Heart Association Diet Impact on Cardiovascular Risk in Obese Hypercholesterolemic 9-18 y.o.
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| ClinicalTrials.gov Identifier: NCT01817491 |
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Recruitment Status :
Completed
First Posted : March 25, 2013
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Disease Hypercholesterolemia Obesity Fatty Liver | Other: American Heart Association Diet Other: Reduced Fat Vegan Diet | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| 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 Hypercholesterolemic Children/Adolescents: A Four Week Randomized Trial |
| Study Start Date : | March 2013 |
| Actual Primary Completion Date : | May 2014 |
| Actual Study Completion Date : | December 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Reduced Fat Vegan Diet
Plant based diet with as few added oils and fats as possible.
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Other: Reduced Fat Vegan Diet |
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Active Comparator: American Heart Association Diet
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
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Other: American Heart Association Diet |
- Change in Body Mass Index BMI Percentile [ Time Frame: baseline, 4 weeks ]
- 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.
- Change in Blood Pressure (BP) [ Time Frame: baseline, 4 weeks ]
- Change in Weight [ Time Frame: baseline, 4 weeks ]
- Change in Circumference [ Time Frame: baseline, 4 weeks ]
- 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.
- Change in Lipid Profile [ Time Frame: baseline, 4 weeks ]
- Change in Glucose [ Time Frame: baseline, 4 weeks ]
- Change in hsCRP (High-sensitivity C-reactive Protein) [ Time Frame: baseline, 4 weeks ]
- Change in Liver Enzymes [ Time Frame: baseline, 4 weeks ]
- Change in IL-6 (Interleukin-6) [ Time Frame: baseline, 4 weeks ]
- Change in MPO (Myeloperoxidase) [ Time Frame: baseline, 4 weeks ]
- Change in HgbA1c (Hemoglobin A1c) [ Time Frame: baseline, 4 weeks ]
- Change in Insulin [ Time Frame: baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Difference BMI [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Difference BMI Z Score Children [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean BP [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Difference Weight [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Difference Circumference [ Time Frame: Baseline, 4 weeks ]
- 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.
- PB/AHA - Adjusted Mean Lipid Profile [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Ratio Glucose [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Ratio hsCRP [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Ratio Liver Enzymes [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Ratio IL-6 [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Ratio MPO [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Ratio HgbA1c [ Time Frame: Baseline, 4 weeks ]
- PB/AHA - Adjusted Mean Ratio Insulin [ Time Frame: Baseline, 4 weeks ]
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| Ages Eligible for Study: | 9 Years to 18 Years (Child, Adult) |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817491
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Michael Macknin, MD | The Cleveland Clinic |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | michael macknin, Professor of Pediatrics Cleveland Clinic Lerner College of Medicine of Case Western Reserve, The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01817491 History of Changes |
| Other Study ID Numbers: |
12-1298 |
| First Posted: | March 25, 2013 Key Record Dates |
| Results First Posted: | June 8, 2018 |
| Last Update Posted: | June 8, 2018 |
| Last Verified: | June 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by michael macknin, The Cleveland Clinic:
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Vegan Diet Hypercholesterolemia American Heart Association Diet Cardiovascular Risk Obesity |
Additional relevant MeSH terms:
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Cardiovascular Diseases Hypercholesterolemia Fatty Liver Hyperlipidemias Dyslipidemias |
Lipid Metabolism Disorders Metabolic Diseases Liver Diseases Digestive System Diseases |