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
| Type | Name | Description |
|---|---|---|
| OTHER | Carbohydrate restricted group | Prescribed low carbohydrate diet with set recipes |
| OTHER | Standard low fat diet | Diet 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.