Carbohydrate restricted group
OtherPrescribed low carbohydrate diet with set recipes
NCT Number: NCT03937960
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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Notify Me10 year–18 year
All sexes
Interventional
Not applicable
Bhuvana Sunil, Birmingham, Alabama, United States
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.
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
Exclusion criteria
Prescribed low carbohydrate diet with set recipes
Diet with less than 20% total calorie intake from dietary fats
Time frame: Baseline
Baseline concentration of serum High-density Lipoprotein level in mg/dL
Time frame: Baseline to 8 weeks
Change in concentration of serum High density Lipoprotein in mg/dL
Time frame: Baseline
Baseline concentration of serum Triglyceride level in mg/dL
Time frame: Baseline to 8 weeks
Change in concentration of serum Triglyceride level in mg/dL
Time frame: Baseline
Baseline concentration of serum lipoprotein particle number
Time frame: Baseline to 8 weeks
Change in concentration of serum lipoprotein particle number in percentage
Time frame: Baseline
Baseline concentration of serum lipoprotein particle concentration
Time frame: Baseline to 8 weeks
Change in concentration of serum lipoprotein particle concentration in percentage
Time frame: Baseline
Baseline total serum high density lipoprotein particle number
Time frame: Baseline to 8 weeks
percentage Change in concentration of serum high density lipoprotein particle
Time frame: Baseline
Baseline concentration of serum small low-density lipoprotein particle concentration
Time frame: Baseline to 8 weeks
Percentage change in concentration of serum small low density lipoprotein particle
Time frame: Baseline
Baseline serum low-density lipoprotein size
Time frame: Baseline to 8 weeks
Percentage change in concentration of serum small low-density lipoprotein size
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
Time frame: Baseline
Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA_IR is a scale where a higher number means worse outcome
Time frame: Baseline
Dual-energy X-ray absorptiometry (DXA) - measure of body fat
Time frame: Baseline to 8 weeks
Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat
Time frame: Baseline
Baseline Pulse wave velocity
Time frame: Baseline to 8 weeks
Percentage Change in Pulse wave velocity
Time frame: Baseline
The Augmentation Index a measure of peripheral arterial stiffness
Time frame: Baseline to 8 weeks
The Augmentation Index a measure of peripheral arterial stiffness
University of Alabama at Birmingham
Other
Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
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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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