Trial Outcomes & Findings for Study of Macronutrients and Heart Disease Risk (NCT NCT00609271)
NCT ID: NCT00609271
Last Updated: 2018-11-19
Results Overview
Predicted mean difference from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
12 months
Results posted on
2018-11-19
Participant Flow
Participant milestones
| Measure |
Low Carbohydrate Diet
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
73
|
|
Overall Study
COMPLETED
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Macronutrients and Heart Disease Risk
Baseline characteristics by cohort
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
47.8 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
46.8 years
STANDARD_DEVIATION 10.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
131 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
40 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
body weight
|
96.3 kg
STANDARD_DEVIATION 12.7 • n=93 Participants
|
97.9 kg
STANDARD_DEVIATION 13.5 • n=4 Participants
|
97.1 kg
STANDARD_DEVIATION 13.1 • n=27 Participants
|
|
body composition
Fat mass
|
40 %
STANDARD_DEVIATION 10 • n=93 Participants
|
40 %
STANDARD_DEVIATION 10 • n=4 Participants
|
40 %
STANDARD_DEVIATION 10 • n=27 Participants
|
|
body composition
Lean Mass
|
60 %
STANDARD_DEVIATION 10 • n=93 Participants
|
60 %
STANDARD_DEVIATION 10 • n=4 Participants
|
60 %
STANDARD_DEVIATION 10 • n=27 Participants
|
|
body mass index
|
35.2 kg/m**2
STANDARD_DEVIATION 3.8 • n=93 Participants
|
35.6 kg/m**2
STANDARD_DEVIATION 4.5 • n=4 Participants
|
35.4 kg/m**2
STANDARD_DEVIATION 4.2 • n=27 Participants
|
|
waist circumference
|
108.4 cm
STANDARD_DEVIATION 9.3 • n=93 Participants
|
111.0 cm
STANDARD_DEVIATION 10.7 • n=4 Participants
|
109.7 cm
STANDARD_DEVIATION 10.1 • n=27 Participants
|
|
systolic blood pressure
|
120.3 mm Hg
STANDARD_DEVIATION 12.8 • n=93 Participants
|
124.9 mm Hg
STANDARD_DEVIATION 13.8 • n=4 Participants
|
122.6 mm Hg
STANDARD_DEVIATION 13.5 • n=27 Participants
|
|
diastolic blood pressure
|
77.5 mm Hg
STANDARD_DEVIATION 9.0 • n=93 Participants
|
79.4 mm Hg
STANDARD_DEVIATION 8.3 • n=4 Participants
|
78.4 mm Hg
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
total cholesterol
|
198.8 mg/dL
STANDARD_DEVIATION 42.2 • n=93 Participants
|
204.3 mg/dL
STANDARD_DEVIATION 40.7 • n=4 Participants
|
201.5 mg/dL
STANDARD_DEVIATION 41.5 • n=27 Participants
|
|
LDL cholesterol
|
122.5 mg/dL
STANDARD_DEVIATION 34.6 • n=93 Participants
|
122.7 mg/dL
STANDARD_DEVIATION 38.6 • n=4 Participants
|
122.6 mg/dL
STANDARD_DEVIATION 36.6 • n=27 Participants
|
|
HDL cholesterol
|
53.8 mg/dL
STANDARD_DEVIATION 13.3 • n=93 Participants
|
56.5 mg/dL
STANDARD_DEVIATION 12.8 • n=4 Participants
|
55.1 mg/dL
STANDARD_DEVIATION 13.1 • n=27 Participants
|
|
total-HDL cholesterol ratio
|
3.8 unitless
STANDARD_DEVIATION 1.0 • n=93 Participants
|
3.8 unitless
STANDARD_DEVIATION 1.0 • n=4 Participants
|
3.8 unitless
STANDARD_DEVIATION 1 • n=27 Participants
|
|
triglycerides
|
112.6 mg/dL
STANDARD_DEVIATION 54.1 • n=93 Participants
|
125.5 mg/dL
STANDARD_DEVIATION 81.3 • n=4 Participants
|
119.0 mg/dL
STANDARD_DEVIATION 69.1 • n=27 Participants
|
|
plasma glucose
|
94.5 mg/dL
STANDARD_DEVIATION 10.9 • n=93 Participants
|
93.4 mg/dL
STANDARD_DEVIATION 9.2 • n=4 Participants
|
94.0 mg/dL
STANDARD_DEVIATION 10.1 • n=27 Participants
|
|
serum insulin
|
102.8 pmol/L
STANDARD_DEVIATION 63.9 • n=93 Participants
|
105.6 pmol/L
STANDARD_DEVIATION 54.9 • n=4 Participants
|
104.2 pmol/L
STANDARD_DEVIATION 59.7 • n=27 Participants
|
|
serum creatinine
|
1.0 mg/dL
STANDARD_DEVIATION 0.2 • n=93 Participants
|
1.1 mg/dL
STANDARD_DEVIATION 0.2 • n=4 Participants
|
1.0 mg/dL
STANDARD_DEVIATION 0.1 • n=27 Participants
|
|
C-reactive protein
|
46.7 nmol/L
STANDARD_DEVIATION 40.0 • n=93 Participants
|
46.7 nmol/L
STANDARD_DEVIATION 48.6 • n=4 Participants
|
46.7 nmol/L
STANDARD_DEVIATION 44.5 • n=27 Participants
|
|
Medication use
Antihypertensive
|
21 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Medication use
Lipid-Lowering
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Physical activity level
|
16.3 MET-h/wk
STANDARD_DEVIATION 26.0 • n=93 Participants
|
19.6 MET-h/wk
STANDARD_DEVIATION 35.5 • n=4 Participants
|
17.9 MET-h/wk
STANDARD_DEVIATION 31.1 • n=27 Participants
|
|
Framingham risk percent
|
3.9 %
STANDARD_DEVIATION 3.1 • n=93 Participants
|
4.2 %
STANDARD_DEVIATION 3.3 • n=4 Participants
|
4.0 %
STANDARD_DEVIATION 18.7 • n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPredicted mean difference from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group
Change in body weight after 3 months
|
-5.7 kg
Interval -6.5 to -4.9
|
-2.6 kg
Interval -3.4 to -1.7
|
|
Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group
Change in body weight after 6 months
|
-5.6 kg
Interval -6.5 to -4.6
|
-2.3 kg
Interval -3.3 to -1.3
|
|
Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group
Change in body weight after 12 months
|
-5.3 kg
Interval -6.8 to -3.8
|
-1.8 kg
Interval -3.3 to -0.3
|
PRIMARY outcome
Timeframe: 12 monthsMean Difference in Lean Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group
Change of % lean mass after 3 months
|
1.6 % of body weight that is lean mass
Interval 1.0 to 2.2
|
0.4 % of body weight that is lean mass
Interval -0.2 to 1.1
|
|
Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group
Change of % lean mass after 6 months
|
1.5 % of body weight that is lean mass
Interval 0.9 to 2.1
|
0.2 % of body weight that is lean mass
Interval -0.4 to 0.7
|
|
Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group
Change of % lean mass after 12 months
|
1.3 % of body weight that is lean mass
Interval 0.5 to 2.0
|
-0.4 % of body weight that is lean mass
Interval -1.2 to 0.4
|
PRIMARY outcome
Timeframe: 12 monthsMean Difference in Fat Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group
Change of % fat mass after 3 months
|
-1.1 % body weight that is fat mass
Interval -1.7 to -0.05
|
-0.3 % body weight that is fat mass
Interval -0.9 to 0.3
|
|
Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group
Change of % fat mass after 6 months
|
-1.1 % body weight that is fat mass
Interval -1.7 to -0.6
|
-0.1 % body weight that is fat mass
Interval -0.6 to 0.5
|
|
Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group
Change of % fat mass after 12 months
|
-1.2 % body weight that is fat mass
Interval -2.0 to -0.4
|
0.3 % body weight that is fat mass
Interval -0.5 to 1.1
|
PRIMARY outcome
Timeframe: 12 monthsPredicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group
Change in waist circumference after 3 mo
|
-5.5 cm
Interval -6.6 to -4.4
|
-3.5 cm
Interval -4.6 to -2.4
|
|
Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group
Change in waist circumference after 6 mo
|
-5.9 cm
Interval -7.1 to -4.7
|
-4.0 cm
Interval -5.2 to -2.8
|
|
Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group
Change in waist circumference after 12 mo
|
-6.7 cm
Interval -8.5 to -4.9
|
-5.0 cm
Interval -6.8 to -3.2
|
PRIMARY outcome
Timeframe: 12 monthsPredicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group
Change of total cholesterol after 3 mo
|
-0.09 mmol/L
Interval -0.21 to 0.04
|
0.03 mmol/L
Interval -0.1 to 0.16
|
|
Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group
Change of total cholesterol after 6 mo
|
-0.04 mmol/L
Interval -0.16 to 0.07
|
0.03 mmol/L
Interval -0.09 to 0.15
|
|
Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group
Change of total cholesterol after 12 mo
|
0.05 mmol/L
Interval -0.11 to 0.2
|
0.03 mmol/L
Interval -0.13 to 0.18
|
PRIMARY outcome
Timeframe: 12 monthsPredicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group
Change in LDL cholesterol level after 3 mo
|
-0.02 mmol/L
Interval -0.14 to 0.1
|
0.05 mmol/L
Interval -0.06 to 0.18
|
|
Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group
Change in LDL cholesterol level after 6 mo
|
-0.04 mmol/L
Interval -0.15 to 0.06
|
0.02 mmol/L
Interval -0.08 to 0.13
|
|
Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group
Change in LDL cholesterol level after 12 mo
|
-0.08 mmol/L
Interval -0.24 to 0.08
|
-0.05 mmol/L
Interval -0.2 to 0.11
|
PRIMARY outcome
Timeframe: 12 monthsPredicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group
Change in HDL cholesterol level after 3 mo
|
0.03 mmol/L
Interval -0.02 to 0.09
|
-0.03 mmol/L
Interval -0.09 to 0.02
|
|
Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group
Change in HDL cholesterol level after 6 mo
|
0.10 mmol/L
Interval 0.05 to 0.15
|
-0.00 mmol/L
Interval -0.05 to 0.05
|
|
Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group
Change in HDL cholesterol level after 12 mo
|
0.24 mmol/L
Interval 0.17 to 0.31
|
0.06 mmol/L
Interval -0.01 to 0.13
|
PRIMARY outcome
Timeframe: 12 monthsPredicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group
Change in Total-HDL cholesterol ratio after 3 mo
|
-0.13 ratio
Interval -0.28 to 0.03
|
0.13 ratio
Interval -0.02 to 0.29
|
|
Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group
Change in Total-HDL cholesterol ratio after 6 mo
|
-0.25 ratio
Interval -0.38 to -0.11
|
0.07 ratio
Interval -0.06 to 0.21
|
|
Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group
Change in Total-HDL cholesterol level after 12 mo
|
-0.49 ratio
Interval -0.68 to -0.29
|
-0.05 ratio
Interval -0.24 to 0.14
|
PRIMARY outcome
Timeframe: 12 monthsPredicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group
Change in Triglycerides after 3 mo
|
-0.21 mmol/L
Interval -0.32 to -0.11
|
0.03 mmol/L
Interval -0.08 to 0.14
|
|
Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group
Change in Triglycerides after 6 mo
|
-0.22 mmol/L
Interval -0.31 to -0.13
|
-0.01 mmol/L
Interval -0.1 to 0.09
|
|
Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group
Change in Triglycerides after 12 mo
|
-0.23 mmol/L
Interval -0.34 to -0.12
|
-0.07 mmol/L
Interval -0.18 to 0.04
|
PRIMARY outcome
Timeframe: 12 monthsPredicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group
Change in Systolic Blood Pressure after 3 mo
|
-4.2 mm Hg
Interval -5.9 to -2.5
|
-2.6 mm Hg
Interval -4.3 to -0.9
|
|
Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group
Change in Systolic Blood Pressure after 6 mo
|
-2.9 mm Hg
Interval -4.5 to -1.3
|
-2.2 mm Hg
Interval -3.8 to -0.6
|
|
Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group
Change in Systolic Blood Pressure after 12 mo
|
-0.2 mm Hg
Interval -2.6 to 2.1
|
-1.3 mm Hg
Interval -3.6 to 1.0
|
PRIMARY outcome
Timeframe: 12 MonthsMean Difference in Diastolic Blood Pressure predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group
Change in Diastolic Blood Pressure after 3 mo
|
-2.3 mm Hg
Interval -3.5 to -1.1
|
-0.9 mm Hg
Interval -2.1 to 0.4
|
|
Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group
Change in Diastolic Blood Pressure after 6 mo
|
-1.7 mm Hg
Interval -2.8 to -0.5
|
-0.5 mm Hg
Interval -1.7 to 0.6
|
|
Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group
Change in Diastolic Blood Pressure after 12 mo
|
-0.5 mm Hg
Interval -2.2 to 1.3
|
0.2 mm Hg
Interval -1.5 to 1.9
|
PRIMARY outcome
Timeframe: 12 monthsMean Difference in Plasma Glucose Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group
Change in Plasma Glucose Level after 3 months
|
-0.05 mmol/L||
Interval -0.16 to 0.05
|
-0.10 mmol/L||
Interval -0.21 to 0.01
|
|
Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group
Change in Plasma Glucose Level after 6 months
|
0.03 mmol/L||
Interval -0.13 to 0.07
|
-0.10 mmol/L||
Interval -0.2 to 0.01
|
|
Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group
Change in Plasma Glucose Level after 12 months
|
0.02 mmol/L||
Interval -0.11 to 0.14
|
-0.10 mmol/L||
Interval -0.22 to 0.03
|
PRIMARY outcome
Timeframe: 12 monthsMean Difference in Serum Insulin Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group
Change in Serum Insulin Level after 3 mo
|
-25.0 pmol/L
Interval -36.1 to -13.9
|
-18.8 pmol/L
Interval -29.9 to -7.0
|
|
Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group
Change in Serum Insulin Level after 6 mo
|
-21.5 pmol/L
Interval -31.3 to -11.8
|
-20.8 pmol/L
Interval -30.6 to -11.1
|
|
Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group
Change in Serum Insulin Level after 12 mo
|
-13.9 pmol/L
Interval -25.7 to -2.8
|
-24.3 pmol/L
Interval -36.1 to -13.2
|
PRIMARY outcome
Timeframe: 12 MonthsMean Difference in C-reactive Protein Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group
Change in Serum Creatinine Level after 3 mo
|
-4.8 nmol/L
Interval -13.3 to 3.8
|
5.7 nmol/L
Interval -2.9 to 13.3
|
|
Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group
Change in Serum Creatinine Level after 6 mo
|
-4.8 nmol/L
Interval -12.4 to 1.9
|
6.7 nmol/L
Interval -1.0 to 13.3
|
|
Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group
Change in Serum Creatinine Level after 12 mo
|
-6.7 nmol/L
Interval -16.2 to 2.9
|
8.6 nmol/L
Interval -1.0 to 18.1
|
PRIMARY outcome
Timeframe: 12 MonthsMean Difference in Serum Creatinine Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group
hange in Serum Creatinine Level after 3 mo
|
-0.1 µmol/L¶
Interval -3.4 to 3.3
|
1.8 µmol/L¶
Interval -1.7 to 5.2
|
|
Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group
hange in Serum Creatinine Level after 6 mo
|
-3.1 µmol/L¶
Interval -6.1 to -0.2
|
-1.7 µmol/L¶
Interval -4.7 to 1.3
|
|
Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group
hange in Serum Creatinine Level after 12 mo
|
-9.2 µmol/L¶
Interval -13.1 to -5.4
|
-8.5 µmol/L¶
Interval -12.3 to -4.6
|
PRIMARY outcome
Timeframe: 12 MonthsMean Difference in 10-y Framingham Risk Score predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.
Outcome measures
| Measure |
Low Carbohydrate Diet
n=75 Participants
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 Participants
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group
Change in 10-Y Framingham Risk Score after 6 mo
|
-0.7 % risk of developing CVD in next 10 yrs
Interval -1.0 to -0.3
|
0.4 % risk of developing CVD in next 10 yrs
Interval 0.0 to 0.8
|
|
Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group
Change in 10-Y Framingham Risk Score after 3 mo
|
-0.5 % risk of developing CVD in next 10 yrs
Interval -1.0 to 0.0
|
0.4 % risk of developing CVD in next 10 yrs
Interval -0.1 to 0.9
|
|
Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group
Change in 10-Y Framingham Risk Score after 12 mo
|
-1.0 % risk of developing CVD in next 10 yrs
Interval -1.6 to -0.5
|
0.4 % risk of developing CVD in next 10 yrs
Interval -0.2 to 0.9
|
Adverse Events
Low Carbohydrate Diet
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Low Fat Diet
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Carbohydrate Diet
n=75 participants at risk
low carbohydrate diet: \<40 grams carbohydrate/day
|
Low Fat Diet
n=73 participants at risk
low fat diet: \<30% fat, \<7% saturated fat
|
|---|---|---|
|
Gastrointestinal disorders
Constipation at 3 months
|
25.3%
19/75
|
17.8%
13/73
|
|
Gastrointestinal disorders
Constipation at 6 months
|
24.0%
18/75
|
26.0%
19/73
|
|
Gastrointestinal disorders
Constipation at 12 months
|
1.3%
1/75
|
23.3%
17/73
|
|
General disorders
Fatigue at 3 months
|
22.7%
17/75
|
12.3%
9/73
|
|
General disorders
Fatigue at 6 months
|
24.0%
18/75
|
30.1%
22/73
|
|
General disorders
Fatigue at 12 months
|
20.0%
15/75
|
21.9%
16/73
|
|
General disorders
Headache at 3 months
|
8.0%
6/75
|
24.7%
18/73
|
|
General disorders
Headache at 6 months
|
16.0%
12/75
|
21.9%
16/73
|
|
General disorders
Headache at 12 months
|
14.7%
11/75
|
30.1%
22/73
|
|
General disorders
Thirst at 3 months
|
18.7%
14/75
|
8.2%
6/73
|
|
General disorders
Thirst at 6 months
|
16.0%
12/75
|
12.3%
9/73
|
|
General disorders
Thirst at 12 months
|
16.0%
12/75
|
13.7%
10/73
|
|
General disorders
Polyuria at 3 months
|
4.0%
3/75
|
11.0%
8/73
|
|
General disorders
Polyuria at 6 months
|
5.3%
4/75
|
6.8%
5/73
|
|
General disorders
Polyuria at 12 months
|
2.7%
2/75
|
5.5%
4/73
|
|
Gastrointestinal disorders
Diarrhea at 3 months
|
5.3%
4/75
|
6.8%
5/73
|
|
Gastrointestinal disorders
Diarrhea at 6 months
|
6.7%
5/75
|
6.8%
5/73
|
|
Gastrointestinal disorders
Diarrhea at 12 months
|
1.3%
1/75
|
4.1%
3/73
|
|
Gastrointestinal disorders
Heartburn at 3 months
|
9.3%
7/75
|
16.4%
12/73
|
|
Gastrointestinal disorders
Heartburn at 6 months
|
16.0%
12/75
|
9.6%
7/73
|
|
Gastrointestinal disorders
Heartburn at 12 months
|
12.0%
9/75
|
24.7%
18/73
|
|
Gastrointestinal disorders
Gas at 3 months
|
25.3%
19/75
|
20.5%
15/73
|
|
Gastrointestinal disorders
Gas at 6 months
|
22.7%
17/75
|
30.1%
22/73
|
|
Gastrointestinal disorders
Gas at 12 months
|
21.3%
16/75
|
31.5%
23/73
|
|
General disorders
Nausea at 3 months
|
5.3%
4/75
|
2.7%
2/73
|
|
General disorders
Nausea at 6 months
|
0.00%
0/75
|
2.7%
2/73
|
|
General disorders
Nausea at 12 months
|
0.00%
0/75
|
4.1%
3/73
|
|
Gastrointestinal disorders
Vomiting at 3 months
|
1.3%
1/75
|
0.00%
0/73
|
|
Gastrointestinal disorders
Vomiting at 6 months
|
0.00%
0/75
|
0.00%
0/73
|
|
Gastrointestinal disorders
Vomiting at 12 months
|
0.00%
0/75
|
0.00%
0/73
|
|
General disorders
Decreased appetite
|
1.3%
1/75
|
2.7%
2/73
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place