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CompletedNCT03937960Updated Dec 22, 2022Results posted

Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome

An interventional study of Carbohydrate restricted group and Standard low fat diet in Metabolic Syndrome, Obesity and Dyslipidemias, sponsored by University of Alabama at Birmingham. Completed at 2 sites in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-12-22.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metabolic Syndrome
  • Obesity
  • Dyslipidemias

Keywords

  • Dietary intervention
  • Anthropometric measure
  • Lipid profile
  • Augmentation Index
  • Flow mediated dilation
  • DXA scan
  • Nuclear magnetic resonance lipid profile
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    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.

    Other: Carbohydrate restricted group

  • Active comparator
    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.

    Other: Standard low fat diet

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

06

What researchers measure

Primary outcomes

  1. Dyslipidemia Measures

    Baseline concentration of serum High-density Lipoprotein level in mg/dL

    Time frame: Baseline

  2. Dyslipidemia Measures

    Change in concentration of serum High density Lipoprotein in mg/dL

    Time frame: Baseline to 8 weeks

  3. Dyslipidemia Measures

    Baseline concentration of serum Triglyceride level in mg/dL

    Time frame: Baseline

  4. Dyslipidemia Measures

    Change in concentration of serum Triglyceride level in mg/dL

    Time frame: Baseline to 8 weeks

  5. Dyslipidemia Measures

    Baseline concentration of serum lipoprotein particle number

    Time frame: Baseline

  6. Dyslipidemia Measures

    Change in concentration of serum lipoprotein particle number in percentage

    Time frame: Baseline to 8 weeks

  7. Dyslipidemia Measures

    Baseline concentration of serum lipoprotein particle concentration

    Time frame: Baseline

  8. Dyslipidemia Measures

    Change in concentration of serum lipoprotein particle concentration in percentage

    Time frame: Baseline to 8 weeks

  9. Dyslipidemia Measures

    Baseline total serum high density lipoprotein particle number

    Time frame: Baseline

  10. Dyslipidemia Measures

    percentage Change in concentration of serum high density lipoprotein particle

    Time frame: Baseline to 8 weeks

  11. Dyslipidemia Measures

    Baseline concentration of serum small low-density lipoprotein particle concentration

    Time frame: Baseline

  12. Dyslipidemia Measures

    Percentage change in concentration of serum small low density lipoprotein particle

    Time frame: Baseline to 8 weeks

  13. Dyslipidemia Measures

    Baseline serum low-density lipoprotein size

    Time frame: Baseline

  14. Dyslipidemia Measures

    Percentage change in concentration of serum small low-density lipoprotein size

    Time frame: Baseline to 8 weeks

  15. 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

Secondary outcomes

  1. 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

  2. Body Composition

    Dual-energy X-ray absorptiometry (DXA) - measure of body fat

    Time frame: Baseline

  3. Body Composition

    Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat

    Time frame: Baseline to 8 weeks

  4. Surrogate Markers of Vascular Endothelial Function

    Baseline Pulse wave velocity

    Time frame: Baseline

  5. Surrogate Markers of Vascular Endothelial Function

    Percentage Change in Pulse wave velocity

    Time frame: Baseline to 8 weeks

  6. Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index

    The Augmentation Index a measure of peripheral arterial stiffness

    Time frame: Baseline

  7. 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

07

Results

Posted Dec 22, 2022

Participant flow

Participant flow — Overall Study
MilestoneStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Started1515
Completed1515
Not completed00

Outcome measures

PrimaryDyslipidemia Measures

Baseline concentration of serum High-density Lipoprotein level in mg/dL

Time frame:
Baseline
Reported as:
Mean · mg/dL
Dyslipidemia Measures
mg/dLStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures30 ± 232 ± 2
PrimaryDyslipidemia Measures

Change in concentration of serum High density Lipoprotein in mg/dL

Time frame:
Baseline to 8 weeks
Reported as:
Mean · mg/dL increase
Dyslipidemia Measures
mg/dL increaseStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures2 ± 0.52.3 ± 0.6
PrimaryDyslipidemia Measures

Baseline concentration of serum Triglyceride level in mg/dL

Time frame:
Baseline
Reported as:
Mean · mg/dL
Dyslipidemia Measures
mg/dLStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures160 ± 5.6163 ± 2.6
PrimaryDyslipidemia Measures

Change in concentration of serum Triglyceride level in mg/dL

Time frame:
Baseline to 8 weeks
Reported as:
Mean · mg/dL
Dyslipidemia Measures
mg/dLStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures-8.7 ± 2.3-8.5 ± 2.1
PrimaryDyslipidemia Measures

Baseline concentration of serum lipoprotein particle number

Time frame:
Baseline
Reported as:
Mean · nmol/L
Dyslipidemia Measures
nmol/LStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures822 ± 125.6821.6 ± 120.8
PrimaryDyslipidemia Measures

Change in concentration of serum lipoprotein particle number in percentage

Time frame:
Baseline to 8 weeks
Reported as:
Mean · percentage change
Dyslipidemia Measures
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures-0.052 ± 0.018-0.036 ± 0.016
PrimaryDyslipidemia Measures

Baseline concentration of serum lipoprotein particle concentration

Time frame:
Baseline
Reported as:
Mean · mg/dL
Dyslipidemia Measures
mg/dLStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures76.2 ± 8.3677.1 ± 9.42
PrimaryDyslipidemia Measures

Change in concentration of serum lipoprotein particle concentration in percentage

Time frame:
Baseline to 8 weeks
Reported as:
Mean · percentage change
Dyslipidemia Measures
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures-0.062 ± 0.01-0.0617 ± 0.003
PrimaryDyslipidemia Measures

Baseline total serum high density lipoprotein particle number

Time frame:
Baseline
Reported as:
Mean · micromol/L
Dyslipidemia Measures
micromol/LStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures30.5 ± 1.830.62 ± 1.7
PrimaryDyslipidemia Measures

percentage Change in concentration of serum high density lipoprotein particle

Time frame:
Baseline to 8 weeks
Reported as:
Mean · percentage change
Dyslipidemia Measures
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures02.76 ± 0.02302.80 ± 0.051
PrimaryDyslipidemia Measures

Baseline concentration of serum small low-density lipoprotein particle concentration

Time frame:
Baseline
Reported as:
Mean · nmol/L
Dyslipidemia Measures
nmol/LStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures413.6 ± 18.3418.2 ± 19.6
PrimaryDyslipidemia Measures

Percentage change in concentration of serum small low density lipoprotein particle

Time frame:
Baseline to 8 weeks
Reported as:
Mean · percentage change
Dyslipidemia Measures
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures-8.6 ± 0.58-8.15 ± 0.73
PrimaryDyslipidemia Measures

Baseline serum low-density lipoprotein size

Time frame:
Baseline
Reported as:
Mean · nm
Dyslipidemia Measures
nmStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures21.62 ± 1.8721.72 ± 2.1
PrimaryDyslipidemia Measures

Percentage change in concentration of serum small low-density lipoprotein size

Time frame:
Baseline to 8 weeks
Reported as:
Mean · percentage change
Dyslipidemia Measures
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Dyslipidemia Measures1.65 ± 0.31.68 ± 0.24
PrimaryInsulin 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
Reported as:
Mean · percentage change
Insulin Resistance Indices
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Insulin Resistance Indices-6.87 ± 0.38-7.65 ± 1.25
SecondaryInsulin 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
Reported as:
Mean · index score
Insulin Resistance Indices
index scoreStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Insulin Resistance Indices2.15 ± 0.122.21 ± 0.16
SecondaryBody Composition

Dual-energy X-ray absorptiometry (DXA) - measure of body fat

Time frame:
Baseline
Reported as:
Mean · % of total body weight
Body Composition
% of total body weightStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Body Composition43.2 ± 5.845.6 ± 4.9
SecondaryBody Composition

Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat

Time frame:
Baseline to 8 weeks
Reported as:
Mean · percentage change
Body Composition
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Body Composition-8.7 ± 2.1-8.84 ± 2.7
SecondarySurrogate Markers of Vascular Endothelial Function

Baseline Pulse wave velocity

Time frame:
Baseline
Reported as:
Mean · m/s
Surrogate Markers of Vascular Endothelial Function
m/sStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Surrogate Markers of Vascular Endothelial Function11 ± 111.2 ± 1.6
SecondarySurrogate Markers of Vascular Endothelial Function

Percentage Change in Pulse wave velocity

Time frame:
Baseline to 8 weeks
Reported as:
Mean · percentage change
Surrogate Markers of Vascular Endothelial Function
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Surrogate Markers of Vascular Endothelial Function-2 ± 1.5-2 ± 1.74
SecondarySurrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index

The Augmentation Index a measure of peripheral arterial stiffness

Time frame:
Baseline
Reported as:
Mean · Percent
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
PercentStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index81.8 ± 7.9888.7 ± 8.76
SecondarySurrogate 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
Reported as:
Mean · percentage change
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
percentage changeStandard/Low Fat Diet GroupCarbohydrate Restricted Group
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index-27 ± 1-28.6 ± 1.5

Adverse events

Collected over Each participant was assessed for adverse events during the duration of their participation for 8 weeks and additionally, for 8 weeks after their completion in the study for a total duration of 16 weeks from the time of enrollment in the study. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard/Low Fat Diet Group0/15 (0%)0/15 (0%)0/15 (0%)
Carbohydrate Restricted Group0/15 (0%)0/15 (0%)0/15 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Carbohydrate Restricted GroupStandard/Low Fat Diet GroupTotal
Mean12 ± 112 ± 1.312 ± 1
Sex: Female, Male
Sex: Female, Male(Participants)Carbohydrate Restricted GroupStandard/Low Fat Diet GroupTotal
Female549
Male101121
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Carbohydrate Restricted GroupStandard/Low Fat Diet GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American8917
White7613
More than one race000
Unknown or Not Reported000
08

Study locations

2 sites
  • Bhuvana Sunil
    Birmingham, Alabama 35233, United States
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
09

References and documents

Study documents

  • Study protocol · Oct 6, 2022
  • Statistical analysis plan · Oct 6, 2022
  • Informed consent form · Jan 15, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03937960
Lead sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Bhuvana Sunil (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
May 6, 2019
Start date
Jan 1, 2020
Primary completion
Feb 28, 2021
Completion
Feb 28, 2021
Results posted
Dec 22, 2022
Last update
Dec 22, 2022

Study contacts

Bhuvana Sunil, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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