Cardiovascular DiseaseNCT01817491
Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol
A study testing American Heart Association Diet and Reduced Fat Vegan Diet in people with Cardiovascular Disease and Hypercholesterolemia, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Cardiovascular Disease, Hypercholesterolemia, Obesity
- What is being tested?
- American Heart Association Diet and Reduced Fat Vegan Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children ages 9-18
- BMI > 95th percentile
- Hypercholesterolemia (>169 mg/dl)
Who cannot join
- Pregnant women
- Patients already on vegetarian diets
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Disease, Hypercholesterolemia, Obesity, Fatty Liver
- Being tested
- American Heart Association Diet, Reduced Fat Vegan Diet
- Keywords
- Vegan Diet, Hypercholesterolemia, American Heart Association Diet, Cardiovascular Risk, Obesity
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Heart Association DietOther
Reduced Fat Vegan DietOther
| Study group | Role | What they receive |
|---|---|---|
| Reduced Fat Vegan Diet | Active comparator | Plant based diet with as few added oils and fats as possible. Receives: Other: Reduced Fat Vegan Diet |
| American Heart Association Diet | Active comparator | Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. Receives: Other: American Heart Association Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index BMI Percentile
Measured: baseline, 4 weeks
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.
Measured: baseline, 4 weeks
Change in Blood Pressure (BP)
Measured: baseline, 4 weeks
Change in Weight
Measured: baseline, 4 weeks
Change in Circumference
Measured: baseline, 4 weeks
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.
Measured: baseline, 4 weeks
Change in Lipid Profile
Measured: baseline, 4 weeks
Change in Glucose
Measured: baseline, 4 weeks
Change in hsCRP (High-sensitivity C-reactive Protein)
Measured: baseline, 4 weeks
Change in Liver Enzymes
Measured: baseline, 4 weeks
Change in IL-6 (Interleukin-6)
Measured: baseline, 4 weeks
Change in MPO (Myeloperoxidase)
Measured: baseline, 4 weeks
Change in HgbA1c (Hemoglobin A1c)
Measured: baseline, 4 weeks
Change in Insulin
Measured: baseline, 4 weeks
Secondary outcomes (14)
PB/AHA - Adjusted Mean Difference BMI
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Difference BMI Z Score Children
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean BP
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Difference Weight
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Difference Circumference
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Lipid Profile
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio Glucose
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio hsCRP
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio Liver Enzymes
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio IL-6
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio MPO
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio HgbA1c
Measured: Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio Insulin
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, michael macknin, The Cleveland Clinic
- Investigators
- Michael Macknin, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817491
- Sponsor's protocol ID
- 12-1298
- Status last verified
- Jan 2021
- First submitted
- 21 Mar 2013
- Last updated
- 15 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents; National Heart, Lung, and Blood Institute. Expert panel on integrated guidelines for cardiovascular health and risk reduction in children and adolescents: summary report. Pediatrics. 2011 Dec;128 Suppl 5(Suppl 5):S213-56. doi: 10.1542/peds.2009-2107C. Epub 2011 Nov 14. No abstract available.
PubMed 22084329Olza J, Aguilera CM, Gil-Campos M, Leis R, Bueno G, Martinez-Jimenez MD, Valle M, Canete R, Tojo R, Moreno LA, Gil A. Myeloperoxidase is an early biomarker of inflammation and cardiovascular risk in prepubertal obese children. Diabetes Care. 2012 Nov;35(11):2373-6. doi: 10.2337/dc12-0614. Epub 2012 Aug 21.
PubMed 22912422Pignatelli P, Loffredo L, Martino F, Catasca E, Carnevale R, Zanoni C, Del Ben M, Antonini R, Basili S, Violi F. Myeloperoxidase overexpression in children with hypercholesterolemia. Atherosclerosis. 2009 Jul;205(1):239-43. doi: 10.1016/j.atherosclerosis.2008.10.025. Epub 2008 Nov 6.
PubMed 19081093Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
PubMed 21475195Tang WH, Wang Z, Cho L, Brennan DM, Hazen SL. Diminished global arginine bioavailability and increased arginine catabolism as metabolic profile of increased cardiovascular risk. J Am Coll Cardiol. 2009 Jun 2;53(22):2061-7. doi: 10.1016/j.jacc.2009.02.036.
PubMed 19477356Wang Z, Tang WH, Cho L, Brennan DM, Hazen SL. Targeted metabolomic evaluation of arginine methylation and cardiovascular risks: potential mechanisms beyond nitric oxide synthase inhibition. Arterioscler Thromb Vasc Biol. 2009 Sep;29(9):1383-91. doi: 10.1161/ATVBAHA.109.185645. Epub 2009 Jun 18.
PubMed 19542023Bhattacharyya T, Nicholls SJ, Topol EJ, Zhang R, Yang X, Schmitt D, Fu X, Shao M, Brennan DM, Ellis SG, Brennan ML, Allayee H, Lusis AJ, Hazen SL. Relationship of paraoxonase 1 (PON1) gene polymorphisms and functional activity with systemic oxidative stress and cardiovascular risk. JAMA. 2008 Mar 19;299(11):1265-76. doi: 10.1001/jama.299.11.1265.
PubMed 18349088Zhang ZJ. Systematic review on the association between F2-isoprostanes and cardiovascular disease. Ann Clin Biochem. 2013 Mar;50(Pt 2):108-14. doi: 10.1258/acb.2012.011263. Epub 2012 Sep 27.
PubMed 23019600Fung TT, Rimm EB, Spiegelman D, Rifai N, Tofler GH, Willett WC, Hu FB. Association between dietary patterns and plasma biomarkers of obesity and cardiovascular disease risk. Am J Clin Nutr. 2001 Jan;73(1):61-7. doi: 10.1093/ajcn/73.1.61.
PubMed 11124751Newby PK. Plant foods and plant-based diets: protective against childhood obesity? Am J Clin Nutr. 2009 May;89(5):1572S-1587S. doi: 10.3945/ajcn.2009.26736G. Epub 2009 Mar 25.
PubMed 19321559Turner-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.
PubMed 17890496Hu 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.
PubMed 12936948Ornish 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.
PubMed 9863851Ley RE, Hamady M, Lozupone C, Turnbaugh PJ, Ramey RR, Bircher JS, Schlegel ML, Tucker TA, Schrenzel MD, Knight R, Gordon JI. Evolution of mammals and their gut microbes. Science. 2008 Jun 20;320(5883):1647-51. doi: 10.1126/science.1155725. Epub 2008 May 22.
PubMed 18497261Muegge BD, Kuczynski J, Knights D, Clemente JC, Gonzalez A, Fontana L, Henrissat B, Knight R, Gordon JI. Diet drives convergence in gut microbiome functions across mammalian phylogeny and within humans. Science. 2011 May 20;332(6032):970-4. doi: 10.1126/science.1198719.
PubMed 21596990
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01817491
- Acronym / sponsor ID
- 12-1298
- Conditions
- Cardiovascular Disease, Hypercholesterolemia, Obesity, Fatty Liver
- Keywords
- Vegan Diet, Hypercholesterolemia, American Heart Association Diet, Cardiovascular Risk, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Posted 8 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Fat Vegan Diet | Active comparator | Other: Reduced Fat Vegan DietPlant based diet with as few added oils and fats as possible. |
| American Heart Association Diet | Active comparator | Other: American Heart Association DietDiet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children ages 9-18
- BMI > 95th percentile
- Hypercholesterolemia (>169 mg/dl)
Key exclusion criteria (2 listed)
- Pregnant women
- Patients already on vegetarian diets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| American Heart Association Diet | Other | American Heart Association Diet |
| Reduced Fat Vegan Diet | Other | Reduced Fat Vegan Diet |
Primary outcome
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
14 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22084329Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents; National Heart, Lung, and Blood Institute. Expert panel on integrated guidelines for cardiovascular health and risk reduction in children and adolescents: summary report. Pediatrics. 2011 Dec;128 Suppl 5(Suppl 5):S213-56. doi: 10.1542/peds.2009-2107C. Epub 2011 Nov 14. No abstract available.
- Background: PubMed 22912422Olza J, Aguilera CM, Gil-Campos M, Leis R, Bueno G, Martinez-Jimenez MD, Valle M, Canete R, Tojo R, Moreno LA, Gil A. Myeloperoxidase is an early biomarker of inflammation and cardiovascular risk in prepubertal obese children. Diabetes Care. 2012 Nov;35(11):2373-6. doi: 10.2337/dc12-0614. Epub 2012 Aug 21.
- Background: PubMed 19081093Pignatelli P, Loffredo L, Martino F, Catasca E, Carnevale R, Zanoni C, Del Ben M, Antonini R, Basili S, Violi F. Myeloperoxidase overexpression in children with hypercholesterolemia. Atherosclerosis. 2009 Jul;205(1):239-43. doi: 10.1016/j.atherosclerosis.2008.10.025. Epub 2008 Nov 6.
- Background: PubMed 21475195Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.
- Background: PubMed 19477356Tang WH, Wang Z, Cho L, Brennan DM, Hazen SL. Diminished global arginine bioavailability and increased arginine catabolism as metabolic profile of increased cardiovascular risk. J Am Coll Cardiol. 2009 Jun 2;53(22):2061-7. doi: 10.1016/j.jacc.2009.02.036.
- Background: PubMed 19542023Wang Z, Tang WH, Cho L, Brennan DM, Hazen SL. Targeted metabolomic evaluation of arginine methylation and cardiovascular risks: potential mechanisms beyond nitric oxide synthase inhibition. Arterioscler Thromb Vasc Biol. 2009 Sep;29(9):1383-91. doi: 10.1161/ATVBAHA.109.185645. Epub 2009 Jun 18.
- Background: PubMed 18349088Bhattacharyya T, Nicholls SJ, Topol EJ, Zhang R, Yang X, Schmitt D, Fu X, Shao M, Brennan DM, Ellis SG, Brennan ML, Allayee H, Lusis AJ, Hazen SL. Relationship of paraoxonase 1 (PON1) gene polymorphisms and functional activity with systemic oxidative stress and cardiovascular risk. JAMA. 2008 Mar 19;299(11):1265-76. doi: 10.1001/jama.299.11.1265.
- Background: PubMed 23019600Zhang ZJ. Systematic review on the association between F2-isoprostanes and cardiovascular disease. Ann Clin Biochem. 2013 Mar;50(Pt 2):108-14. doi: 10.1258/acb.2012.011263. Epub 2012 Sep 27.
- Background: PubMed 11124751Fung TT, Rimm EB, Spiegelman D, Rifai N, Tofler GH, Willett WC, Hu FB. Association between dietary patterns and plasma biomarkers of obesity and cardiovascular disease risk. Am J Clin Nutr. 2001 Jan;73(1):61-7. doi: 10.1093/ajcn/73.1.61.
- Background: PubMed 19321559Newby PK. Plant foods and plant-based diets: protective against childhood obesity? Am J Clin Nutr. 2009 May;89(5):1572S-1587S. doi: 10.3945/ajcn.2009.26736G. Epub 2009 Mar 25.
- Background: PubMed 17890496Turner-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.
- Background: PubMed 12936948Hu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Macknin, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing American Heart Association Diet and Reduced Fat Vegan Diet in people with Cardiovascular Disease and Hypercholesterolemia, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index BMI Percentile (time frame: baseline, 4 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817491, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.