Trial Outcomes & Findings for Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol (NCT NCT01817491)
NCT ID: NCT01817491
Last Updated: 2021-01-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
baseline, 4 weeks
Results posted on
2021-01-15
Participant Flow
Participant milestones
| Measure |
Reduced Fat Vegan Diet
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol
Baseline characteristics by cohort
| Measure |
Reduced Fat Vegan Diet
n=32 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Adolescents
|
15 years
n=5 Participants
|
15 years
n=7 Participants
|
15 years
n=5 Participants
|
|
Age, Continuous
Parents
|
46.5 years
n=5 Participants
|
46.0 years
n=7 Participants
|
46.25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
28 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children only
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in Body Mass Index BMI Percentile
Children
|
-1.12 BMI percentile
Standard Deviation 1.69
|
-0.08 BMI percentile
Standard Deviation 0.42
|
|
Change in Body Mass Index BMI Percentile
Parents
|
-1.29 BMI percentile
Standard Deviation 1.14
|
-0.73 BMI percentile
Standard Deviation 0.92
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children only
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.
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=14 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=14 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Children Change in BMI Z Score
|
-0.14 Z Score
Standard Deviation 0.16
|
-0.03 Z Score
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in Blood Pressure (BP)
Parent Diastolic BP
|
-3.46 mm Hg
Standard Deviation 11.06
|
-6.64 mm Hg
Standard Deviation 12.19
|
|
Change in Blood Pressure (BP)
Children Systolic BP
|
-6.43 mm Hg
Standard Deviation 8.86
|
-5.14 mm Hg
Standard Deviation 17.64
|
|
Change in Blood Pressure (BP)
Parents Systolic BP
|
-7.96 mm Hg
Standard Deviation 12.28
|
-3.14 mm Hg
Standard Deviation 14.42
|
|
Change in Blood Pressure (BP)
Children Diastolic BP
|
-2.61 mm Hg
Standard Deviation 10.25
|
-4.36 mm Hg
Standard Deviation 14.67
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in Weight
Children
|
-3.05 kg
Standard Deviation 3.27
|
-1.55 kg
Standard Deviation 1.83
|
|
Change in Weight
Parents
|
-3.64 kg
Standard Deviation 3.41
|
-2.01 kg
Standard Deviation 2.66
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in Circumference
Children Waist Circumference
|
-1.53 cm
Standard Deviation 3.01
|
-2.96 cm
Standard Deviation 4.04
|
|
Change in Circumference
Parents Waist Circumference
|
-1.94 cm
Standard Deviation 5.80
|
-0.49 cm
Standard Deviation 5.73
|
|
Change in Circumference
Children Midarm Circumference
|
-2.02 cm
Standard Deviation 2.17
|
-1.14 cm
Standard Deviation 1.63
|
|
Change in Circumference
Parents Midarm Circumference
|
-1.32 cm
Standard Deviation 2.06
|
0.35 cm
Standard Deviation 3.16
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: 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.
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=14 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=14 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in PAQ (Physical Activity Questionnaire)
|
0.22 units on a scale
Standard Deviation 0.53
|
-0.16 units on a scale
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in Lipid Profile
total cholesterol children
|
-22.50 mg/dL
Standard Deviation 36.31
|
-16.50 mg/dL
Standard Deviation 28.19
|
|
Change in Lipid Profile
triglycerides children
|
-25.50 mg/dL
Standard Deviation 95.26
|
-13.14 mg/dL
Standard Deviation 36.19
|
|
Change in Lipid Profile
high-density lipoprotein cholesterol children
|
-5.93 mg/dL
Standard Deviation 9.37
|
-2.93 mg/dL
Standard Deviation 3.71
|
|
Change in Lipid Profile
low-density lipoprotein cholesterol children
|
-13.14 mg/dL
Standard Deviation 35.54
|
-11.00 mg/dL
Standard Deviation 23.31
|
|
Change in Lipid Profile
total cholesterol parents
|
-33.79 mg/dL
Standard Deviation 30.84
|
-7.14 mg/dL
Standard Deviation 24.93
|
|
Change in Lipid Profile
triglycerides parents
|
6.21 mg/dL
Standard Deviation 41.71
|
16.86 mg/dL
Standard Deviation 36.86
|
|
Change in Lipid Profile
high-density lipoprotein cholesterol parents
|
-8.14 mg/dL
Standard Deviation 41.71
|
16.86 mg/dL
Standard Deviation 36.86
|
|
Change in Lipid Profile
low-density lipoprotein cholesterol parents
|
-27.00 mg/dL
Standard Deviation 26.72
|
-5.50 mg/dL
Standard Deviation 20.89
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in Glucose
Children
|
0.93 mg/dL
Standard Deviation 6.01
|
-.64 mg/dL
Standard Deviation 5.02
|
|
Change in Glucose
Parent
|
4.93 mg/dL
Standard Deviation 24.65
|
-5.43 mg/dL
Standard Deviation 12.40
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in hsCRP (High-sensitivity C-reactive Protein)
Children
|
-2.09 mg/L
Standard Deviation 7.10
|
2.78 mg/L
Standard Deviation 8.76
|
|
Change in hsCRP (High-sensitivity C-reactive Protein)
Parent
|
-0.24 mg/L
Standard Deviation 1.36
|
0.21 mg/L
Standard Deviation 1.90
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in Liver Enzymes
alanine aminotransferase (ALT) children
|
0.79 U/L
Standard Deviation 14.35
|
-1.14 U/L
Standard Deviation 3.46
|
|
Change in Liver Enzymes
aspartate aminotransferase (AST) children
|
2.79 U/L
Standard Deviation 8.96
|
0.00 U/L
Standard Deviation 4.69
|
|
Change in Liver Enzymes
alanine aminotransferase (ALT) parents
|
0.86 U/L
Standard Deviation 7.01
|
4.57 U/L
Standard Deviation 9.69
|
|
Change in Liver Enzymes
aspartate aminotransferase (AST) parents
|
0.14 U/L
Standard Deviation 5.70
|
4.43 U/L
Standard Deviation 6.73
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in IL-6 (Interleukin-6)
Children
|
-0.17 pg/ml
Standard Deviation 0.89
|
-0.19 pg/ml
Standard Deviation 3.14
|
|
Change in IL-6 (Interleukin-6)
Parent
|
0.16 pg/ml
Standard Deviation 0.90
|
-0.19 pg/ml
Standard Deviation 0.85
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in MPO (Myeloperoxidase)
Children
|
-75.34 pmol/L
Standard Deviation 37.34
|
-69.23 pmol/L
Standard Deviation 72.92
|
|
Change in MPO (Myeloperoxidase)
Parent
|
16.91 pmol/L
Standard Deviation 110.66
|
1.78 pmol/L
Standard Deviation 45.93
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in HgbA1c (Hemoglobin A1c)
Children
|
0.17 percentage
Standard Deviation 0.17
|
0.21 percentage
Standard Deviation 0.12
|
|
Change in HgbA1c (Hemoglobin A1c)
Parent
|
-0.16 percentage
Standard Deviation 0.16
|
0.14 percentage
Standard Deviation 0.49
|
PRIMARY outcome
Timeframe: baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
American Heart Association Diet
n=28 Participants
Diet emphasizing fruits, vegetables and whole grains but also low fat dairy, low fat meat and fish.
American Heart Association Diet
|
|---|---|---|
|
Change in Insulin
Children
|
-5.42 uU/ml
Standard Deviation 5.68
|
3.16 uU/ml
Standard Deviation 25.62
|
|
Change in Insulin
Parents
|
-3.11 uU/ml
Standard Deviation 8.56
|
-3.15 uU/ml
Standard Deviation 5.47
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Difference BMI
Children Change in BMI
|
-1.17 percentile
Interval -2.2 to -0.14
|
—
|
|
PB/AHA - Adjusted Mean Difference BMI
Parents Change in BMI
|
-0.69 percentile
Interval -1.47 to 0.09
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Difference BMI Z Score Children
|
-0.13 Z score
Interval -0.24 to -0.03
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean BP
Children adj mean ratio systolic BP
|
1.87 ratio
Interval -4.41 to 8.15
|
—
|
|
PB/AHA - Adjusted Mean BP
Children adj mean ratio diastolic BP
|
1.01 ratio
Interval 0.92 to 1.11
|
—
|
|
PB/AHA - Adjusted Mean BP
parents adj mean ratio systolic BP
|
0.97 ratio
Interval 0.89 to 1.05
|
—
|
|
PB/AHA - Adjusted Mean BP
parents adj mean ratio diastolic BP
|
1.03 ratio
Interval 0.94 to 1.13
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Difference Weight
Children Weight
|
-1.71 kg
Interval -3.8 to 0.39
|
—
|
|
PB/AHA - Adjusted Mean Difference Weight
Parents Weight
|
-1.95 kg
Interval -4.16 to 0.26
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Difference Circumference
children waist circumference
|
1.32 cm
Interval -1.66 to 4.3
|
—
|
|
PB/AHA - Adjusted Mean Difference Circumference
parents waist circumference
|
-1.14 cm
Interval -5.75 to 3.48
|
—
|
|
PB/AHA - Adjusted Mean Difference Circumference
children arm circumference
|
-1.25 cm
Interval -2.61 to 0.11
|
—
|
|
PB/AHA - Adjusted Mean Difference Circumference
parents arm circumference
|
-1.68 cm
Interval -3.8 to 0.44
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: 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.
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=28 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Difference PAQ Children
|
0.39 units on a scale
Interval -0.02 to 0.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Lipid Profile
CHOL children
|
-10.34 mg/dL
Interval -36.48 to 15.8
|
—
|
|
PB/AHA - Adjusted Mean Lipid Profile
TRIG children
|
1.01 mg/dL
Interval 0.77 to 1.32
|
—
|
|
PB/AHA - Adjusted Mean Lipid Profile
HDL children
|
0.17 mg/dL
Interval -5.07 to 5.4
|
—
|
|
PB/AHA - Adjusted Mean Lipid Profile
LDL children
|
0.95 mg/dL
Interval 0.8 to 1.13
|
—
|
|
PB/AHA - Adjusted Mean Lipid Profile
CHOL parents
|
-27.29 mg/dL
Interval -48.68 to -5.9
|
—
|
|
PB/AHA - Adjusted Mean Lipid Profile
TRIG parents
|
0.95 mg/dL
Interval 0.76 to 1.19
|
—
|
|
PB/AHA - Adjusted Mean Lipid Profile
HDL parents
|
0.94 mg/dL
Interval 0.87 to 1.02
|
—
|
|
PB/AHA - Adjusted Mean Lipid Profile
LDL parents
|
-21.92 mg/dL
Interval -40.37 to -3.46
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Ratio Glucose
Children
|
1.01 ratio
Interval 0.96 to 1.05
|
—
|
|
PB/AHA - Adjusted Mean Ratio Glucose
Parents
|
1.06 ratio
Interval 0.97 to 1.16
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Ratio hsCRP
Children
|
0.46 ratio
Interval 0.21 to 1.0
|
—
|
|
PB/AHA - Adjusted Mean Ratio hsCRP
Parents
|
0.68 ratio
Interval 0.44 to 1.07
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Ratio Liver Enzymes
ALT children
|
1 ratio
Interval 0.76 to 1.32
|
—
|
|
PB/AHA - Adjusted Mean Ratio Liver Enzymes
AST children
|
1.13 ratio
Interval 0.92 to 1.4
|
—
|
|
PB/AHA - Adjusted Mean Ratio Liver Enzymes
ALT parents
|
0.85 ratio
Interval 0.67 to 1.08
|
—
|
|
PB/AHA - Adjusted Mean Ratio Liver Enzymes
AST parents
|
0.83 ratio
Interval 0.68 to 1.03
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Ratio IL-6
Children
|
0.26 ratio
Interval 0.05 to 1.37
|
—
|
|
PB/AHA - Adjusted Mean Ratio IL-6
Parents
|
1.14 ratio
Interval 0.83 to 1.57
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Ratio MPO
Children
|
0.95 ratio
Interval 0.79 to 1.13
|
—
|
|
PB/AHA - Adjusted Mean Ratio MPO
Parents
|
0.93 ratio
Interval 0.8 to 1.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Ratio HgbA1c
Children
|
0.99 ratio
Interval 0.97 to 1.01
|
—
|
|
PB/AHA - Adjusted Mean Ratio HgbA1c
Parents
|
0.96 ratio
Interval 0.92 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Children and Parents
Outcome measures
| Measure |
Reduced Fat Vegan Diet
n=56 Participants
Plant based diet with as few added oils and fats as possible.
Reduced Fat Vegan Diet
|
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
|
|---|---|---|
|
PB/AHA - Adjusted Mean Ratio Insulin
Children
|
0.7 ratio
Interval 0.43 to 1.12
|
—
|
|
PB/AHA - Adjusted Mean Ratio Insulin
Parents
|
0.87 ratio
Interval 0.67 to 1.13
|
—
|
Adverse Events
Reduced Fat Vegan Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
American Heart Association Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place