Cardiovascular Disease, Fatty Liver, Hypercholesterolemia, Obesity
Conditions
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
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin | baseline, 4 weeks | — |
| Change in Body Mass Index BMI Percentile | baseline, 4 weeks | — |
| Children Change in BMI Z Score | 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) | baseline, 4 weeks | — |
| Change in Weight | baseline, 4 weeks | — |
| Change in Circumference | baseline, 4 weeks | — |
| Change in PAQ (Physical Activity Questionnaire) | 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 | baseline, 4 weeks | — |
| Change in Glucose | baseline, 4 weeks | — |
| Change in hsCRP (High-sensitivity C-reactive Protein) | baseline, 4 weeks | — |
| Change in Liver Enzymes | baseline, 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
| Measure | Time frame | Description |
|---|---|---|
| PB/AHA - Adjusted Mean Ratio Glucose | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Ratio hsCRP | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Ratio Liver Enzymes | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Ratio IL-6 | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Ratio MPO | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Ratio HgbA1c | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Ratio Insulin | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Difference Weight | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Difference Circumference | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Difference PAQ Children | 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 | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Difference BMI | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean Difference BMI Z Score Children | Baseline, 4 weeks | — |
| PB/AHA - Adjusted Mean BP | Baseline, 4 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 60 |
Baseline characteristics
| Characteristic | Reduced Fat Vegan Diet | American Heart Association Diet | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 14 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Age, Continuous Adolescents | 15 years | 15 years | 15 years |
| Age, Continuous Parents | 46.5 years | 46.0 years | 46.25 years |
| Region of Enrollment United States | 32 participants | 28 participants | 60 participants |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 28 |
| serious Total, serious adverse events | 0 / 32 | 0 / 28 |
Outcome results
Change in Blood Pressure (BP)
Time frame: baseline, 4 weeks
Population: Children and parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in Blood Pressure (BP) | Children Systolic BP | -6.43 mm Hg | Standard Deviation 8.86 |
| Reduced Fat Vegan Diet | Change in Blood Pressure (BP) | Parents Systolic BP | -7.96 mm Hg | Standard Deviation 12.28 |
| Reduced Fat Vegan Diet | Change in Blood Pressure (BP) | Children Diastolic BP | -2.61 mm Hg | Standard Deviation 10.25 |
| Reduced Fat Vegan Diet | Change in Blood Pressure (BP) | Parent Diastolic BP | -3.46 mm Hg | Standard Deviation 11.06 |
| American Heart Association Diet | Change in Blood Pressure (BP) | Parent Diastolic BP | -6.64 mm Hg | Standard Deviation 12.19 |
| American Heart Association Diet | Change in Blood Pressure (BP) | Children Systolic BP | -5.14 mm Hg | Standard Deviation 17.64 |
| American Heart Association Diet | Change in Blood Pressure (BP) | Children Diastolic BP | -4.36 mm Hg | Standard Deviation 14.67 |
| American Heart Association Diet | Change in Blood Pressure (BP) | Parents Systolic BP | -3.14 mm Hg | Standard Deviation 14.42 |
Change in Body Mass Index BMI Percentile
Time frame: baseline, 4 weeks
Population: Children only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in Body Mass Index BMI Percentile | Children | -1.12 BMI percentile | Standard Deviation 1.69 |
| Reduced Fat Vegan Diet | Change in Body Mass Index BMI Percentile | Parents | -1.29 BMI percentile | Standard Deviation 1.14 |
| American Heart Association Diet | Change in Body Mass Index BMI Percentile | Children | -0.08 BMI percentile | Standard Deviation 0.42 |
| American Heart Association Diet | Change in Body Mass Index BMI Percentile | Parents | -0.73 BMI percentile | Standard Deviation 0.92 |
Change in Circumference
Time frame: baseline, 4 weeks
Population: Children and parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in Circumference | Children Waist Circumference | -1.53 cm | Standard Deviation 3.01 |
| Reduced Fat Vegan Diet | Change in Circumference | Parents Waist Circumference | -1.94 cm | Standard Deviation 5.8 |
| Reduced Fat Vegan Diet | Change in Circumference | Children Midarm Circumference | -2.02 cm | Standard Deviation 2.17 |
| Reduced Fat Vegan Diet | Change in Circumference | Parents Midarm Circumference | -1.32 cm | Standard Deviation 2.06 |
| American Heart Association Diet | Change in Circumference | Parents Midarm Circumference | 0.35 cm | Standard Deviation 3.16 |
| American Heart Association Diet | Change in Circumference | Children Waist Circumference | -2.96 cm | Standard Deviation 4.04 |
| American Heart Association Diet | Change in Circumference | Children Midarm Circumference | -1.14 cm | Standard Deviation 1.63 |
| American Heart Association Diet | Change in Circumference | Parents Waist Circumference | -0.49 cm | Standard Deviation 5.73 |
Change in Glucose
Time frame: baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in Glucose | Children | 0.93 mg/dL | Standard Deviation 6.01 |
| Reduced Fat Vegan Diet | Change in Glucose | Parent | 4.93 mg/dL | Standard Deviation 24.65 |
| American Heart Association Diet | Change in Glucose | Children | -.64 mg/dL | Standard Deviation 5.02 |
| American Heart Association Diet | Change in Glucose | Parent | -5.43 mg/dL | Standard Deviation 12.4 |
Change in HgbA1c (Hemoglobin A1c)
Time frame: baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in HgbA1c (Hemoglobin A1c) | Children | 0.17 percentage | Standard Deviation 0.17 |
| Reduced Fat Vegan Diet | Change in HgbA1c (Hemoglobin A1c) | Parent | -0.16 percentage | Standard Deviation 0.16 |
| American Heart Association Diet | Change in HgbA1c (Hemoglobin A1c) | Children | 0.21 percentage | Standard Deviation 0.12 |
| American Heart Association Diet | Change in HgbA1c (Hemoglobin A1c) | Parent | 0.14 percentage | Standard Deviation 0.49 |
Change in hsCRP (High-sensitivity C-reactive Protein)
Time frame: baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in hsCRP (High-sensitivity C-reactive Protein) | Children | -2.09 mg/L | Standard Deviation 7.1 |
| Reduced Fat Vegan Diet | Change in hsCRP (High-sensitivity C-reactive Protein) | Parent | -0.24 mg/L | Standard Deviation 1.36 |
| American Heart Association Diet | Change in hsCRP (High-sensitivity C-reactive Protein) | Children | 2.78 mg/L | Standard Deviation 8.76 |
| American Heart Association Diet | Change in hsCRP (High-sensitivity C-reactive Protein) | Parent | 0.21 mg/L | Standard Deviation 1.9 |
Change in IL-6 (Interleukin-6)
Time frame: baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in IL-6 (Interleukin-6) | Children | -0.17 pg/ml | Standard Deviation 0.89 |
| Reduced Fat Vegan Diet | Change in IL-6 (Interleukin-6) | Parent | 0.16 pg/ml | Standard Deviation 0.9 |
| American Heart Association Diet | Change in IL-6 (Interleukin-6) | Parent | -0.19 pg/ml | Standard Deviation 0.85 |
| American Heart Association Diet | Change in IL-6 (Interleukin-6) | Children | -0.19 pg/ml | Standard Deviation 3.14 |
Change in Insulin
Time frame: baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in Insulin | Children | -5.42 uU/ml | Standard Deviation 5.68 |
| Reduced Fat Vegan Diet | Change in Insulin | Parents | -3.11 uU/ml | Standard Deviation 8.56 |
| American Heart Association Diet | Change in Insulin | Children | 3.16 uU/ml | Standard Deviation 25.62 |
| American Heart Association Diet | Change in Insulin | Parents | -3.15 uU/ml | Standard Deviation 5.47 |
Change in Lipid Profile
Time frame: baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in Lipid Profile | total cholesterol parents | -33.79 mg/dL | Standard Deviation 30.84 |
| Reduced Fat Vegan Diet | Change in Lipid Profile | triglycerides children | -25.50 mg/dL | Standard Deviation 95.26 |
| Reduced Fat Vegan Diet | Change in Lipid Profile | triglycerides parents | 6.21 mg/dL | Standard Deviation 41.71 |
| Reduced Fat Vegan Diet | Change in Lipid Profile | total cholesterol children | -22.50 mg/dL | Standard Deviation 36.31 |
| Reduced Fat Vegan Diet | Change in Lipid Profile | high-density lipoprotein cholesterol parents | -8.14 mg/dL | Standard Deviation 41.71 |
| Reduced Fat Vegan Diet | Change in Lipid Profile | high-density lipoprotein cholesterol children | -5.93 mg/dL | Standard Deviation 9.37 |
| Reduced Fat Vegan Diet | Change in Lipid Profile | low-density lipoprotein cholesterol parents | -27.00 mg/dL | Standard Deviation 26.72 |
| Reduced Fat Vegan Diet | Change in Lipid Profile | low-density lipoprotein cholesterol children | -13.14 mg/dL | Standard Deviation 35.54 |
| American Heart Association Diet | Change in Lipid Profile | low-density lipoprotein cholesterol parents | -5.50 mg/dL | Standard Deviation 20.89 |
| American Heart Association Diet | Change in Lipid Profile | total cholesterol children | -16.50 mg/dL | Standard Deviation 28.19 |
| American Heart Association Diet | Change in Lipid Profile | triglycerides children | -13.14 mg/dL | Standard Deviation 36.19 |
| American Heart Association Diet | Change in Lipid Profile | low-density lipoprotein cholesterol children | -11.00 mg/dL | Standard Deviation 23.31 |
| American Heart Association Diet | Change in Lipid Profile | total cholesterol parents | -7.14 mg/dL | Standard Deviation 24.93 |
| American Heart Association Diet | Change in Lipid Profile | triglycerides parents | 16.86 mg/dL | Standard Deviation 36.86 |
| American Heart Association Diet | Change in Lipid Profile | high-density lipoprotein cholesterol parents | 16.86 mg/dL | Standard Deviation 36.86 |
| American Heart Association Diet | Change in Lipid Profile | high-density lipoprotein cholesterol children | -2.93 mg/dL | Standard Deviation 3.71 |
Change in Liver Enzymes
Time frame: baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in Liver Enzymes | alanine aminotransferase (ALT) children | 0.79 U/L | Standard Deviation 14.35 |
| Reduced Fat Vegan Diet | Change in Liver Enzymes | aspartate aminotransferase (AST) children | 2.79 U/L | Standard Deviation 8.96 |
| Reduced Fat Vegan Diet | Change in Liver Enzymes | alanine aminotransferase (ALT) parents | 0.86 U/L | Standard Deviation 7.01 |
| Reduced Fat Vegan Diet | Change in Liver Enzymes | aspartate aminotransferase (AST) parents | 0.14 U/L | Standard Deviation 5.7 |
| American Heart Association Diet | Change in Liver Enzymes | aspartate aminotransferase (AST) parents | 4.43 U/L | Standard Deviation 6.73 |
| American Heart Association Diet | Change in Liver Enzymes | alanine aminotransferase (ALT) children | -1.14 U/L | Standard Deviation 3.46 |
| American Heart Association Diet | Change in Liver Enzymes | alanine aminotransferase (ALT) parents | 4.57 U/L | Standard Deviation 9.69 |
| American Heart Association Diet | Change in Liver Enzymes | aspartate aminotransferase (AST) children | 0.00 U/L | Standard Deviation 4.69 |
Change in MPO (Myeloperoxidase)
Time frame: baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in MPO (Myeloperoxidase) | Children | -75.34 pmol/L | Standard Deviation 37.34 |
| Reduced Fat Vegan Diet | Change in MPO (Myeloperoxidase) | Parent | 16.91 pmol/L | Standard Deviation 110.66 |
| American Heart Association Diet | Change in MPO (Myeloperoxidase) | Children | -69.23 pmol/L | Standard Deviation 72.92 |
| American Heart Association Diet | Change in MPO (Myeloperoxidase) | Parent | 1.78 pmol/L | Standard Deviation 45.93 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reduced Fat Vegan Diet | Change in PAQ (Physical Activity Questionnaire) | 0.22 units on a scale | Standard Deviation 0.53 |
| American Heart Association Diet | Change in PAQ (Physical Activity Questionnaire) | -0.16 units on a scale | Standard Deviation 0.54 |
Change in Weight
Time frame: baseline, 4 weeks
Population: Children and parents
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced Fat Vegan Diet | Change in Weight | Children | -3.05 kg | Standard Deviation 3.27 |
| Reduced Fat Vegan Diet | Change in Weight | Parents | -3.64 kg | Standard Deviation 3.41 |
| American Heart Association Diet | Change in Weight | Children | -1.55 kg | Standard Deviation 1.83 |
| American Heart Association Diet | Change in Weight | Parents | -2.01 kg | Standard Deviation 2.66 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reduced Fat Vegan Diet | Children Change in BMI Z Score | -0.14 Z Score | Standard Deviation 0.16 |
| American Heart Association Diet | Children Change in BMI Z Score | -0.03 Z Score | Standard Deviation 0.07 |
PB/AHA - Adjusted Mean BP
Time frame: Baseline, 4 weeks
Population: Children and parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean BP | Children adj mean ratio systolic BP | 1.87 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean BP | Children adj mean ratio diastolic BP | 1.01 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean BP | parents adj mean ratio systolic BP | 0.97 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean BP | parents adj mean ratio diastolic BP | 1.03 ratio |
PB/AHA - Adjusted Mean Difference BMI
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference BMI | Children Change in BMI | -1.17 percentile |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference BMI | Parents Change in BMI | -0.69 percentile |
PB/AHA - Adjusted Mean Difference BMI Z Score Children
Time frame: Baseline, 4 weeks
Population: Children
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference BMI Z Score Children | -0.13 Z score |
PB/AHA - Adjusted Mean Difference Circumference
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference Circumference | children waist circumference | 1.32 cm |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference Circumference | parents waist circumference | -1.14 cm |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference Circumference | children arm circumference | -1.25 cm |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference Circumference | parents arm circumference | -1.68 cm |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference PAQ Children | 0.39 units on a scale |
PB/AHA - Adjusted Mean Difference Weight
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference Weight | Children Weight | -1.71 kg |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Difference Weight | Parents Weight | -1.95 kg |
PB/AHA - Adjusted Mean Lipid Profile
Time frame: Baseline, 4 weeks
Population: Children and parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Lipid Profile | CHOL children | -10.34 mg/dL |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Lipid Profile | TRIG children | 1.01 mg/dL |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Lipid Profile | HDL children | 0.17 mg/dL |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Lipid Profile | LDL children | 0.95 mg/dL |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Lipid Profile | CHOL parents | -27.29 mg/dL |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Lipid Profile | TRIG parents | 0.95 mg/dL |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Lipid Profile | HDL parents | 0.94 mg/dL |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Lipid Profile | LDL parents | -21.92 mg/dL |
PB/AHA - Adjusted Mean Ratio Glucose
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio Glucose | Children | 1.01 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio Glucose | Parents | 1.06 ratio |
PB/AHA - Adjusted Mean Ratio HgbA1c
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio HgbA1c | Children | 0.99 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio HgbA1c | Parents | 0.96 ratio |
PB/AHA - Adjusted Mean Ratio hsCRP
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio hsCRP | Children | 0.46 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio hsCRP | Parents | 0.68 ratio |
PB/AHA - Adjusted Mean Ratio IL-6
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio IL-6 | Children | 0.26 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio IL-6 | Parents | 1.14 ratio |
PB/AHA - Adjusted Mean Ratio Insulin
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio Insulin | Children | 0.7 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio Insulin | Parents | 0.87 ratio |
PB/AHA - Adjusted Mean Ratio Liver Enzymes
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio Liver Enzymes | ALT children | 1 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio Liver Enzymes | AST children | 1.13 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio Liver Enzymes | ALT parents | 0.85 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio Liver Enzymes | AST parents | 0.83 ratio |
PB/AHA - Adjusted Mean Ratio MPO
Time frame: Baseline, 4 weeks
Population: Children and Parents
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio MPO | Children | 0.95 ratio |
| Reduced Fat Vegan Diet | PB/AHA - Adjusted Mean Ratio MPO | Parents | 0.93 ratio |