Dyslipidemias, Metabolic Syndrome, Obesity
Conditions
Keywords
Dietary intervention, Anthropometric measure, Lipid profile, Augmentation Index, Flow mediated dilation, DXA scan, Nuclear magnetic resonance lipid profile
Brief summary
Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.
Detailed description
Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and cardiovascular markers will occur at baseline during the initial clinic visit. Individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the PI. Dietary intake will be assessed with weekly food records (weeks 1-8). The return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming.
Interventions
OTHERCarbohydrate restricted group
Prescribed low carbohydrate diet with set recipes
OTHERStandard low fat diet
Diet with less than 20% total calorie intake from dietary fats
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
3 out of 5 of the following criteria * Metabolic syndrome with dyslipidemia * (HDL \<40mg/dL * Triglyceride (TG) TG\>150mg/dL) * Glucose intolerance (fasting blood sugar \>100mg/dL) * Central adiposity (Waist circumference ≥90th percentile or adult cutoff if lower) * Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg or treatment of previously diagnosed hypertension
Exclusion criteria
* Patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants) * Pregnancy * Untreated thyroid disease, heart disease, cancer, kidney disease * Children on statin/fibrate treatments or other lipid-lowering medications * Prior surgical procedure for weight control or current weight loss medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyslipidemia Measures | Baseline | Baseline concentration of serum High-density Lipoprotein level in mg/dL |
| Insulin Resistance Indices | Baseline to 8 weeks | Percentage change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA\_IR is a scale where a higher number means worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Resistance Indices | Baseline | Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA\_IR is a scale where a higher number means worse outcome |
| Body Composition | Baseline | Dual-energy X-ray absorptiometry (DXA) - measure of body fat |
| Surrogate Markers of Vascular Endothelial Function | Baseline | Baseline Pulse wave velocity |
| Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index | Baseline | The Augmentation Index a measure of peripheral arterial stiffness |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carbohydrate Restricted Group This diet is designed to minimize intake of carbohydrate sources such as added sugars, high glycemic grains, and fructose. It will provide a fixed amount of carbohydrate, and a total calorie goal - with proteins and fats to satiety. During the first two weeks of the intervention, carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day. At week three, additional CHO sources will be added back to the diet prescription including nuts, unsweetened yogurt, and low-glycemic fruits such as apples and berries.
Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes | 15 |
| Standard/Low Fat Diet Group The control, low-fat diet will contain 55:25:20 %energy from CHO: protein: fat based on the United States Department of Agriculture (USDA) My Plate Daily Food Plan and our groups previous work. For example, an 1800 kcal/d plan will include 5 ounces lean meats, 3 cups low-fat dairy, 6 ounces of whole grains, 1 ½ cups fruit, 2 ½ cups vegetables (starchy and non-starchy) and limited fats.
Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Standard/Low Fat Diet Group | Total | Carbohydrate Restricted Group |
|---|---|---|---|
| Age, Continuous | 12 years STANDARD_DEVIATION 1.3 | 12 years STANDARD_DEVIATION 1 | 12 years STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Dyslipidemia Measures
Percentage change in concentration of serum small low-density lipoprotein size
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 1.65 percentage change | Standard Deviation 0.3 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 1.68 percentage change | Standard Deviation 0.24 |
Primary
Dyslipidemia Measures
Baseline concentration of serum High-density Lipoprotein level in mg/dL
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 30 mg/dL | Standard Deviation 2 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 32 mg/dL | Standard Deviation 2 |
Primary
Dyslipidemia Measures
Baseline concentration of serum Triglyceride level in mg/dL
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 160 mg/dL | Standard Deviation 5.6 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 163 mg/dL | Standard Deviation 2.6 |
Primary
Dyslipidemia Measures
Change in concentration of serum Triglyceride level in mg/dL
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | -8.7 mg/dL | Standard Deviation 2.3 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | -8.5 mg/dL | Standard Deviation 2.1 |
Primary
Dyslipidemia Measures
Baseline concentration of serum lipoprotein particle number
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 822 nmol/L | Standard Deviation 125.6 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 821.6 nmol/L | Standard Deviation 120.8 |
Primary
Dyslipidemia Measures
Change in concentration of serum lipoprotein particle number in percentage
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | -0.052 percentage change | Standard Deviation 0.018 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | -0.036 percentage change | Standard Deviation 0.016 |
Primary
Dyslipidemia Measures
Baseline concentration of serum lipoprotein particle concentration
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 76.2 mg/dL | Standard Deviation 8.36 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 77.1 mg/dL | Standard Deviation 9.42 |
Primary
Dyslipidemia Measures
Change in concentration of serum lipoprotein particle concentration in percentage
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | -0.062 percentage change | Standard Deviation 0.01 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | -0.0617 percentage change | Standard Deviation 0.003 |
Primary
Dyslipidemia Measures
Baseline total serum high density lipoprotein particle number
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 30.5 micromol/L | Standard Deviation 1.8 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 30.62 micromol/L | Standard Deviation 1.7 |
Primary
Dyslipidemia Measures
percentage Change in concentration of serum high density lipoprotein particle
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 02.76 percentage change | Standard Deviation 0.023 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 02.80 percentage change | Standard Deviation 0.051 |
Primary
Dyslipidemia Measures
Baseline concentration of serum small low-density lipoprotein particle concentration
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 413.6 nmol/L | Standard Deviation 18.3 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 418.2 nmol/L | Standard Deviation 19.6 |
Primary
Dyslipidemia Measures
Change in concentration of serum High density Lipoprotein in mg/dL
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 2 mg/dL increase | Standard Deviation 0.5 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 2.3 mg/dL increase | Standard Deviation 0.6 |
Primary
Dyslipidemia Measures
Percentage change in concentration of serum small low density lipoprotein particle
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | -8.6 percentage change | Standard Deviation 0.58 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | -8.15 percentage change | Standard Deviation 0.73 |
Primary
Dyslipidemia Measures
Baseline serum low-density lipoprotein size
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Dyslipidemia Measures | 21.62 nm | Standard Deviation 1.87 |
| Carbohydrate Restricted Group | Dyslipidemia Measures | 21.72 nm | Standard Deviation 2.1 |
Primary
Insulin Resistance Indices
Percentage change in Serum measure of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA\_IR is a scale where a higher number means worse outcome
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Insulin Resistance Indices | -6.87 percentage change | Standard Deviation 0.38 |
| Carbohydrate Restricted Group | Insulin Resistance Indices | -7.65 percentage change | Standard Deviation 1.25 |
Secondary
Body Composition
Dual-energy X-ray absorptiometry (DXA) - measure of body fat
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Body Composition | 43.2 % of total body weight | Standard Deviation 5.8 |
| Carbohydrate Restricted Group | Body Composition | 45.6 % of total body weight | Standard Deviation 4.9 |
Secondary
Body Composition
Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Body Composition | -8.7 percentage change | Standard Deviation 2.1 |
| Carbohydrate Restricted Group | Body Composition | -8.84 percentage change | Standard Deviation 2.7 |
Secondary
Insulin Resistance Indices
Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) HOMA\_IR is a scale where a higher number means worse outcome
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Insulin Resistance Indices | 2.15 index score | Standard Deviation 0.12 |
| Carbohydrate Restricted Group | Insulin Resistance Indices | 2.21 index score | Standard Deviation 0.16 |
Secondary
Surrogate Markers of Vascular Endothelial Function
Baseline Pulse wave velocity
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Surrogate Markers of Vascular Endothelial Function | 11 m/s | Standard Deviation 1 |
| Carbohydrate Restricted Group | Surrogate Markers of Vascular Endothelial Function | 11.2 m/s | Standard Deviation 1.6 |
Secondary
Surrogate Markers of Vascular Endothelial Function
Percentage Change in Pulse wave velocity
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Surrogate Markers of Vascular Endothelial Function | -2 percentage change | Standard Deviation 1.5 |
| Carbohydrate Restricted Group | Surrogate Markers of Vascular Endothelial Function | -2 percentage change | Standard Deviation 1.74 |
Secondary
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
The Augmentation Index a measure of peripheral arterial stiffness
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index | 81.8 Percent | Standard Deviation 7.98 |
| Carbohydrate Restricted Group | Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index | 88.7 Percent | Standard Deviation 8.76 |
Secondary
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
The Augmentation Index a measure of peripheral arterial stiffness
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard/Low Fat Diet Group | Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index | -27 percentage change | Standard Error 1 |
| Carbohydrate Restricted Group | Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index | -28.6 percentage change | Standard Error 1.5 |