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Completed

NCT Number: NCT03937960

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bhuvana Sunil, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate restricted group

Other

Prescribed low carbohydrate diet with set recipes

Standard low fat diet

Other

Diet with less than 20% total calorie intake from dietary fats

Primary outcomes

  1. Dyslipidemia Measures

    Time frame: Baseline

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

  2. Dyslipidemia Measures

    Time frame: Baseline to 8 weeks

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

  3. Dyslipidemia Measures

    Time frame: Baseline

    Baseline concentration of serum Triglyceride level in mg/dL

  4. Dyslipidemia Measures

    Time frame: Baseline to 8 weeks

    Change in concentration of serum Triglyceride level in mg/dL

  5. Dyslipidemia Measures

    Time frame: Baseline

    Baseline concentration of serum lipoprotein particle number

  6. Dyslipidemia Measures

    Time frame: Baseline to 8 weeks

    Change in concentration of serum lipoprotein particle number in percentage

  7. Dyslipidemia Measures

    Time frame: Baseline

    Baseline concentration of serum lipoprotein particle concentration

  8. Dyslipidemia Measures

    Time frame: Baseline to 8 weeks

    Change in concentration of serum lipoprotein particle concentration in percentage

  9. Dyslipidemia Measures

    Time frame: Baseline

    Baseline total serum high density lipoprotein particle number

  10. Dyslipidemia Measures

    Time frame: Baseline to 8 weeks

    percentage Change in concentration of serum high density lipoprotein particle

  11. Dyslipidemia Measures

    Time frame: Baseline

    Baseline concentration of serum small low-density lipoprotein particle concentration

  12. Dyslipidemia Measures

    Time frame: Baseline to 8 weeks

    Percentage change in concentration of serum small low density lipoprotein particle

  13. Dyslipidemia Measures

    Time frame: Baseline

    Baseline serum low-density lipoprotein size

  14. Dyslipidemia Measures

    Time frame: Baseline to 8 weeks

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

  15. Insulin Resistance Indices

    Time frame: 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 outcomes

  1. Insulin Resistance Indices

    Time frame: Baseline

    Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    HOMA_IR is a scale where a higher number means worse outcome

  2. Body Composition

    Time frame: Baseline

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

  3. Body Composition

    Time frame: Baseline to 8 weeks

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

  4. Surrogate Markers of Vascular Endothelial Function

    Time frame: Baseline

    Baseline Pulse wave velocity

  5. Surrogate Markers of Vascular Endothelial Function

    Time frame: Baseline to 8 weeks

    Percentage Change in Pulse wave velocity

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

    Time frame: Baseline

    The Augmentation Index a measure of peripheral arterial stiffness

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

    Time frame: Baseline to 8 weeks

    The Augmentation Index a measure of peripheral arterial stiffness

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 6, 2019
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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