Clinical Trials Directory

Trials / Completed

CompletedNCT03937960

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
10 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERCarbohydrate restricted groupPrescribed low carbohydrate diet with set recipes
OTHERStandard low fat dietDiet with less than 20% total calorie intake from dietary fats

Timeline

Start date
2020-01-01
Primary completion
2021-02-28
Completion
2021-02-28
First posted
2019-05-06
Last updated
2022-12-22
Results posted
2022-12-22

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03937960. Inclusion in this directory is not an endorsement.