Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 12/31/2019 |
| Първо изпратено: | 04/23/2019 |
| Очаквано записване подадено: | 04/30/2019 |
| Първо публикувано: | 05/05/2019 |
| Изпратена последна актуализация: | 01/16/2020 |
| Последна актуализация публикувана: | 01/20/2020 |
| Действителна начална дата на проучването: | 12/31/2019 |
| Приблизителна дата на първично завършване: | 06/29/2020 |
| Очаквана дата на завършване на проучването: | 06/29/2021 |
Състояние или заболяване
Интервенция / лечение
Other: Carbohydrate restricted group
Other: Standard/Low fat diet group
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| 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 Prescribed low carbohydrate diet with set recipes |
| 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 group Diet with less than 20% total calorie intake from dietary fats |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 10 Years Да се 10 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Dyslipidemia measures [Baseline]
2. Dyslipidemia measures [Baseline to 8 weeks]
3. Dyslipidemia measures [Baseline]
4. Dyslipidemia measures [Baseline to 8 weeks]
5. Dyslipidemia measures [Baseline]
6. Dyslipidemia measures [Baseline to 8 weeks]
7. Dyslipidemia measures [Baseline]
8. Dyslipidemia measures [Baseline to 8 weeks]
9. Dyslipidemia measures [Baseline]
10. Dyslipidemia measures [Baseline to 8 weeks]
11. Dyslipidemia measures [Baseline]
12. Dyslipidemia measures [Baseline to 8 weeks]
13. Dyslipidemia measures [Baseline]
14. Dyslipidemia measures [Baseline to 8 weeks]
Вторични изходни мерки
1. Insulin resistance indices [Baseline]
2. Insulin resistance indices [Baseline to 8 weeks]
3. Body composition [Baseline]
4. Body composition [Baseline to 8 weeks]
5. Body composition [Baseline]
6. Body composition [Baseline to 8 weeks]
7. Surrogate markers of vascular endothelial function [Baseline]
8. Surrogate markers of vascular endothelial function [Baseline to 8 weeks]
9. Surrogate markers of vascular endothelial function [Baseline]
10. Surrogate markers of vascular endothelial function [Baseline to 8 weeks]
11. Surrogate markers of vascular endothelial function as measured by Augmentation index [Baseline]
12. Surrogate markers of vascular endothelial function as measured by Augmentation index [Baseline to 8 weeks]
