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
: Unknown
Verified September 2013 by michael macknin, The Cleveland Clinic.
Recruitment status was: Active, not recruiting
First Posted
: March 25, 2013
Last Update Posted
: September 20, 2013
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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 | Early Phase 1 |
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) |
| Estimated 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 |
| Estimated Primary Completion Date : | May 2014 |
| Estimated Study Completion Date : | May 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 |
- Biomarkers of cardiovascular risk [ Time Frame: 4 weeks ]Lipid panel, Myeloperoxidase, High-sensitive C-reactive protein, Insulin, Glucose,Hgb A1C, ALT, AST, IL6, Breath test - will measure 22 volatile organic compounds (possible fatty liver markers), Trimethylamine N-oxide, Global arginine bioavailability ratio, Arginine methylation index, Paraoxonase 1 gene, F2-isoprostane (urinary), intestinal microbiota
- Anthropometric measurements [ Time Frame: 4 weeks ]Height, Weight, BMI, Waist circumference, Blood pressure, Tanner staging
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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 |
| Last Update Posted: | September 20, 2013 |
| Last Verified: | September 2013 |
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 |