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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01817491
Enrollment
60
Registered
2013-03-25
Start date
2013-03-31
Completion date
2014-12-31
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Fatty Liver, Hypercholesterolemia, Obesity

Keywords

Vegan Diet, Hypercholesterolemia, American Heart Association Diet, Cardiovascular Risk, Obesity

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.

Interventions

OTHERReduced Fat Vegan Diet

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Insulinbaseline, 4 weeks
Change in Body Mass Index BMI Percentilebaseline, 4 weeks
Children Change in BMI Z Scorebaseline, 4 weeksBody 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)baseline, 4 weeks
Change in Weightbaseline, 4 weeks
Change in Circumferencebaseline, 4 weeks
Change in PAQ (Physical Activity Questionnaire)baseline, 4 weeksPAQ 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 Profilebaseline, 4 weeks
Change in Glucosebaseline, 4 weeks
Change in hsCRP (High-sensitivity C-reactive Protein)baseline, 4 weeks
Change in Liver Enzymesbaseline, 4 weeks
Change in IL-6 (Interleukin-6)baseline, 4 weeks
Change in MPO (Myeloperoxidase)baseline, 4 weeks
Change in HgbA1c (Hemoglobin A1c)baseline, 4 weeks

Secondary

MeasureTime frameDescription
PB/AHA - Adjusted Mean Ratio GlucoseBaseline, 4 weeks
PB/AHA - Adjusted Mean Ratio hsCRPBaseline, 4 weeks
PB/AHA - Adjusted Mean Ratio Liver EnzymesBaseline, 4 weeks
PB/AHA - Adjusted Mean Ratio IL-6Baseline, 4 weeks
PB/AHA - Adjusted Mean Ratio MPOBaseline, 4 weeks
PB/AHA - Adjusted Mean Ratio HgbA1cBaseline, 4 weeks
PB/AHA - Adjusted Mean Ratio InsulinBaseline, 4 weeks
PB/AHA - Adjusted Mean Difference WeightBaseline, 4 weeks
PB/AHA - Adjusted Mean Difference CircumferenceBaseline, 4 weeks
PB/AHA - Adjusted Mean Difference PAQ ChildrenBaseline, 4 weeksPAQ 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 ProfileBaseline, 4 weeks
PB/AHA - Adjusted Mean Difference BMIBaseline, 4 weeks
PB/AHA - Adjusted Mean Difference BMI Z Score ChildrenBaseline, 4 weeks
PB/AHA - Adjusted Mean BPBaseline, 4 weeks

Countries

United States

Participant flow

Participants by arm

ArmCount
Reduced Fat Vegan Diet
Plant based diet with as few added oils and fats as possible. Reduced Fat Vegan Diet
32
American Heart Association Diet
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish. American Heart Association Diet
28
Total60

Baseline characteristics

CharacteristicReduced Fat Vegan DietAmerican Heart Association DietTotal
Age, Categorical
<=18 years
16 Participants14 Participants30 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
16 Participants14 Participants30 Participants
Age, Continuous
Adolescents
15 years15 years15 years
Age, Continuous
Parents
46.5 years46.0 years46.25 years
Region of Enrollment
United States
32 participants28 participants60 participants
Sex: Female, Male
Female
21 Participants19 Participants40 Participants
Sex: Female, Male
Male
11 Participants9 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 320 / 28
serious
Total, serious adverse events
0 / 320 / 28

Outcome results

Primary

Change in Blood Pressure (BP)

Time frame: baseline, 4 weeks

Population: Children and parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in Blood Pressure (BP)Children Systolic BP-6.43 mm HgStandard Deviation 8.86
Reduced Fat Vegan DietChange in Blood Pressure (BP)Parents Systolic BP-7.96 mm HgStandard Deviation 12.28
Reduced Fat Vegan DietChange in Blood Pressure (BP)Children Diastolic BP-2.61 mm HgStandard Deviation 10.25
Reduced Fat Vegan DietChange in Blood Pressure (BP)Parent Diastolic BP-3.46 mm HgStandard Deviation 11.06
American Heart Association DietChange in Blood Pressure (BP)Parent Diastolic BP-6.64 mm HgStandard Deviation 12.19
American Heart Association DietChange in Blood Pressure (BP)Children Systolic BP-5.14 mm HgStandard Deviation 17.64
American Heart Association DietChange in Blood Pressure (BP)Children Diastolic BP-4.36 mm HgStandard Deviation 14.67
American Heart Association DietChange in Blood Pressure (BP)Parents Systolic BP-3.14 mm HgStandard Deviation 14.42
Primary

Change in Body Mass Index BMI Percentile

Time frame: baseline, 4 weeks

Population: Children only

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in Body Mass Index BMI PercentileChildren-1.12 BMI percentileStandard Deviation 1.69
Reduced Fat Vegan DietChange in Body Mass Index BMI PercentileParents-1.29 BMI percentileStandard Deviation 1.14
American Heart Association DietChange in Body Mass Index BMI PercentileChildren-0.08 BMI percentileStandard Deviation 0.42
American Heart Association DietChange in Body Mass Index BMI PercentileParents-0.73 BMI percentileStandard Deviation 0.92
Primary

Change in Circumference

Time frame: baseline, 4 weeks

Population: Children and parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in CircumferenceChildren Waist Circumference-1.53 cmStandard Deviation 3.01
Reduced Fat Vegan DietChange in CircumferenceParents Waist Circumference-1.94 cmStandard Deviation 5.8
Reduced Fat Vegan DietChange in CircumferenceChildren Midarm Circumference-2.02 cmStandard Deviation 2.17
Reduced Fat Vegan DietChange in CircumferenceParents Midarm Circumference-1.32 cmStandard Deviation 2.06
American Heart Association DietChange in CircumferenceParents Midarm Circumference0.35 cmStandard Deviation 3.16
American Heart Association DietChange in CircumferenceChildren Waist Circumference-2.96 cmStandard Deviation 4.04
American Heart Association DietChange in CircumferenceChildren Midarm Circumference-1.14 cmStandard Deviation 1.63
American Heart Association DietChange in CircumferenceParents Waist Circumference-0.49 cmStandard Deviation 5.73
Primary

Change in Glucose

Time frame: baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in GlucoseChildren0.93 mg/dLStandard Deviation 6.01
Reduced Fat Vegan DietChange in GlucoseParent4.93 mg/dLStandard Deviation 24.65
American Heart Association DietChange in GlucoseChildren-.64 mg/dLStandard Deviation 5.02
American Heart Association DietChange in GlucoseParent-5.43 mg/dLStandard Deviation 12.4
Primary

Change in HgbA1c (Hemoglobin A1c)

Time frame: baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in HgbA1c (Hemoglobin A1c)Children0.17 percentageStandard Deviation 0.17
Reduced Fat Vegan DietChange in HgbA1c (Hemoglobin A1c)Parent-0.16 percentageStandard Deviation 0.16
American Heart Association DietChange in HgbA1c (Hemoglobin A1c)Children0.21 percentageStandard Deviation 0.12
American Heart Association DietChange in HgbA1c (Hemoglobin A1c)Parent0.14 percentageStandard Deviation 0.49
Primary

Change in hsCRP (High-sensitivity C-reactive Protein)

Time frame: baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in hsCRP (High-sensitivity C-reactive Protein)Children-2.09 mg/LStandard Deviation 7.1
Reduced Fat Vegan DietChange in hsCRP (High-sensitivity C-reactive Protein)Parent-0.24 mg/LStandard Deviation 1.36
American Heart Association DietChange in hsCRP (High-sensitivity C-reactive Protein)Children2.78 mg/LStandard Deviation 8.76
American Heart Association DietChange in hsCRP (High-sensitivity C-reactive Protein)Parent0.21 mg/LStandard Deviation 1.9
Primary

Change in IL-6 (Interleukin-6)

Time frame: baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in IL-6 (Interleukin-6)Children-0.17 pg/mlStandard Deviation 0.89
Reduced Fat Vegan DietChange in IL-6 (Interleukin-6)Parent0.16 pg/mlStandard Deviation 0.9
American Heart Association DietChange in IL-6 (Interleukin-6)Parent-0.19 pg/mlStandard Deviation 0.85
American Heart Association DietChange in IL-6 (Interleukin-6)Children-0.19 pg/mlStandard Deviation 3.14
Primary

Change in Insulin

Time frame: baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in InsulinChildren-5.42 uU/mlStandard Deviation 5.68
Reduced Fat Vegan DietChange in InsulinParents-3.11 uU/mlStandard Deviation 8.56
American Heart Association DietChange in InsulinChildren3.16 uU/mlStandard Deviation 25.62
American Heart Association DietChange in InsulinParents-3.15 uU/mlStandard Deviation 5.47
Primary

Change in Lipid Profile

Time frame: baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in Lipid Profiletotal cholesterol parents-33.79 mg/dLStandard Deviation 30.84
Reduced Fat Vegan DietChange in Lipid Profiletriglycerides children-25.50 mg/dLStandard Deviation 95.26
Reduced Fat Vegan DietChange in Lipid Profiletriglycerides parents6.21 mg/dLStandard Deviation 41.71
Reduced Fat Vegan DietChange in Lipid Profiletotal cholesterol children-22.50 mg/dLStandard Deviation 36.31
Reduced Fat Vegan DietChange in Lipid Profilehigh-density lipoprotein cholesterol parents-8.14 mg/dLStandard Deviation 41.71
Reduced Fat Vegan DietChange in Lipid Profilehigh-density lipoprotein cholesterol children-5.93 mg/dLStandard Deviation 9.37
Reduced Fat Vegan DietChange in Lipid Profilelow-density lipoprotein cholesterol parents-27.00 mg/dLStandard Deviation 26.72
Reduced Fat Vegan DietChange in Lipid Profilelow-density lipoprotein cholesterol children-13.14 mg/dLStandard Deviation 35.54
American Heart Association DietChange in Lipid Profilelow-density lipoprotein cholesterol parents-5.50 mg/dLStandard Deviation 20.89
American Heart Association DietChange in Lipid Profiletotal cholesterol children-16.50 mg/dLStandard Deviation 28.19
American Heart Association DietChange in Lipid Profiletriglycerides children-13.14 mg/dLStandard Deviation 36.19
American Heart Association DietChange in Lipid Profilelow-density lipoprotein cholesterol children-11.00 mg/dLStandard Deviation 23.31
American Heart Association DietChange in Lipid Profiletotal cholesterol parents-7.14 mg/dLStandard Deviation 24.93
American Heart Association DietChange in Lipid Profiletriglycerides parents16.86 mg/dLStandard Deviation 36.86
American Heart Association DietChange in Lipid Profilehigh-density lipoprotein cholesterol parents16.86 mg/dLStandard Deviation 36.86
American Heart Association DietChange in Lipid Profilehigh-density lipoprotein cholesterol children-2.93 mg/dLStandard Deviation 3.71
Primary

Change in Liver Enzymes

Time frame: baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in Liver Enzymesalanine aminotransferase (ALT) children0.79 U/LStandard Deviation 14.35
Reduced Fat Vegan DietChange in Liver Enzymesaspartate aminotransferase (AST) children2.79 U/LStandard Deviation 8.96
Reduced Fat Vegan DietChange in Liver Enzymesalanine aminotransferase (ALT) parents0.86 U/LStandard Deviation 7.01
Reduced Fat Vegan DietChange in Liver Enzymesaspartate aminotransferase (AST) parents0.14 U/LStandard Deviation 5.7
American Heart Association DietChange in Liver Enzymesaspartate aminotransferase (AST) parents4.43 U/LStandard Deviation 6.73
American Heart Association DietChange in Liver Enzymesalanine aminotransferase (ALT) children-1.14 U/LStandard Deviation 3.46
American Heart Association DietChange in Liver Enzymesalanine aminotransferase (ALT) parents4.57 U/LStandard Deviation 9.69
American Heart Association DietChange in Liver Enzymesaspartate aminotransferase (AST) children0.00 U/LStandard Deviation 4.69
Primary

Change in MPO (Myeloperoxidase)

Time frame: baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in MPO (Myeloperoxidase)Children-75.34 pmol/LStandard Deviation 37.34
Reduced Fat Vegan DietChange in MPO (Myeloperoxidase)Parent16.91 pmol/LStandard Deviation 110.66
American Heart Association DietChange in MPO (Myeloperoxidase)Children-69.23 pmol/LStandard Deviation 72.92
American Heart Association DietChange in MPO (Myeloperoxidase)Parent1.78 pmol/LStandard Deviation 45.93
Primary

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.

Time frame: baseline, 4 weeks

Population: Children

ArmMeasureValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in PAQ (Physical Activity Questionnaire)0.22 units on a scaleStandard Deviation 0.53
American Heart Association DietChange in PAQ (Physical Activity Questionnaire)-0.16 units on a scaleStandard Deviation 0.54
Primary

Change in Weight

Time frame: baseline, 4 weeks

Population: Children and parents

ArmMeasureGroupValue (MEAN)Dispersion
Reduced Fat Vegan DietChange in WeightChildren-3.05 kgStandard Deviation 3.27
Reduced Fat Vegan DietChange in WeightParents-3.64 kgStandard Deviation 3.41
American Heart Association DietChange in WeightChildren-1.55 kgStandard Deviation 1.83
American Heart Association DietChange in WeightParents-2.01 kgStandard Deviation 2.66
Primary

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.

Time frame: baseline, 4 weeks

Population: Children only

ArmMeasureValue (MEAN)Dispersion
Reduced Fat Vegan DietChildren Change in BMI Z Score-0.14 Z ScoreStandard Deviation 0.16
American Heart Association DietChildren Change in BMI Z Score-0.03 Z ScoreStandard Deviation 0.07
Secondary

PB/AHA - Adjusted Mean BP

Time frame: Baseline, 4 weeks

Population: Children and parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean BPChildren adj mean ratio systolic BP1.87 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean BPChildren adj mean ratio diastolic BP1.01 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean BPparents adj mean ratio systolic BP0.97 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean BPparents adj mean ratio diastolic BP1.03 ratio
Secondary

PB/AHA - Adjusted Mean Difference BMI

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference BMIChildren Change in BMI-1.17 percentile
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference BMIParents Change in BMI-0.69 percentile
Secondary

PB/AHA - Adjusted Mean Difference BMI Z Score Children

Time frame: Baseline, 4 weeks

Population: Children

ArmMeasureValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference BMI Z Score Children-0.13 Z score
Secondary

PB/AHA - Adjusted Mean Difference Circumference

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference Circumferencechildren waist circumference1.32 cm
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference Circumferenceparents waist circumference-1.14 cm
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference Circumferencechildren arm circumference-1.25 cm
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference Circumferenceparents arm circumference-1.68 cm
Secondary

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.

Time frame: Baseline, 4 weeks

Population: Children

ArmMeasureValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference PAQ Children0.39 units on a scale
Secondary

PB/AHA - Adjusted Mean Difference Weight

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference WeightChildren Weight-1.71 kg
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Difference WeightParents Weight-1.95 kg
Secondary

PB/AHA - Adjusted Mean Lipid Profile

Time frame: Baseline, 4 weeks

Population: Children and parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Lipid ProfileCHOL children-10.34 mg/dL
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Lipid ProfileTRIG children1.01 mg/dL
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Lipid ProfileHDL children0.17 mg/dL
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Lipid ProfileLDL children0.95 mg/dL
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Lipid ProfileCHOL parents-27.29 mg/dL
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Lipid ProfileTRIG parents0.95 mg/dL
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Lipid ProfileHDL parents0.94 mg/dL
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Lipid ProfileLDL parents-21.92 mg/dL
Secondary

PB/AHA - Adjusted Mean Ratio Glucose

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio GlucoseChildren1.01 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio GlucoseParents1.06 ratio
Secondary

PB/AHA - Adjusted Mean Ratio HgbA1c

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio HgbA1cChildren0.99 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio HgbA1cParents0.96 ratio
Secondary

PB/AHA - Adjusted Mean Ratio hsCRP

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio hsCRPChildren0.46 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio hsCRPParents0.68 ratio
Secondary

PB/AHA - Adjusted Mean Ratio IL-6

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio IL-6Children0.26 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio IL-6Parents1.14 ratio
Secondary

PB/AHA - Adjusted Mean Ratio Insulin

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio InsulinChildren0.7 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio InsulinParents0.87 ratio
Secondary

PB/AHA - Adjusted Mean Ratio Liver Enzymes

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio Liver EnzymesALT children1 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio Liver EnzymesAST children1.13 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio Liver EnzymesALT parents0.85 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio Liver EnzymesAST parents0.83 ratio
Secondary

PB/AHA - Adjusted Mean Ratio MPO

Time frame: Baseline, 4 weeks

Population: Children and Parents

ArmMeasureGroupValue (MEAN)
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio MPOChildren0.95 ratio
Reduced Fat Vegan DietPB/AHA - Adjusted Mean Ratio MPOParents0.93 ratio

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026