Trial Outcomes & Findings for Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome (NCT NCT03937960)

NCT ID: NCT03937960

Last Updated: 2022-12-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-12-22

Participant Flow

Participant milestones

Measure	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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Total n=30 Participants Total of all reporting groups
Age, Continuous	12 years STANDARD_DEVIATION 1 • n=5 Participants	12 years STANDARD_DEVIATION 1.3 • n=7 Participants	12 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	30 mg/dL Standard Deviation 2	32 mg/dL Standard Deviation 2

PRIMARY outcome

Timeframe: Baseline to 8 weeks

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

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	2 mg/dL increase Standard Deviation 0.5	2.3 mg/dL increase Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline

Baseline concentration of serum Triglyceride level in mg/dL

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	160 mg/dL Standard Deviation 5.6	163 mg/dL Standard Deviation 2.6

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Change in concentration of serum Triglyceride level in mg/dL

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	-8.7 mg/dL Standard Deviation 2.3	-8.5 mg/dL Standard Deviation 2.1

PRIMARY outcome

Timeframe: Baseline

Baseline concentration of serum lipoprotein particle number

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	822 nmol/L Standard Deviation 125.6	821.6 nmol/L Standard Deviation 120.8

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Change in concentration of serum lipoprotein particle number in percentage

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	-0.052 percentage change Standard Deviation 0.018	-0.036 percentage change Standard Deviation 0.016

PRIMARY outcome

Timeframe: Baseline

Baseline concentration of serum lipoprotein particle concentration

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	76.2 mg/dL Standard Deviation 8.36	77.1 mg/dL Standard Deviation 9.42

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Change in concentration of serum lipoprotein particle concentration in percentage

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	-0.062 percentage change Standard Deviation 0.01	-0.0617 percentage change Standard Deviation 0.003

PRIMARY outcome

Timeframe: Baseline

Baseline total serum high density lipoprotein particle number

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	30.5 micromol/L Standard Deviation 1.8	30.62 micromol/L Standard Deviation 1.7

PRIMARY outcome

Timeframe: Baseline to 8 weeks

percentage Change in concentration of serum high density lipoprotein particle

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	02.76 percentage change Standard Deviation 0.023	02.80 percentage change Standard Deviation 0.051

PRIMARY outcome

Timeframe: Baseline

Baseline concentration of serum small low-density lipoprotein particle concentration

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	413.6 nmol/L Standard Deviation 18.3	418.2 nmol/L Standard Deviation 19.6

PRIMARY outcome

Timeframe: Baseline to 8 weeks

Percentage change in concentration of serum small low density lipoprotein particle

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	-8.6 percentage change Standard Deviation 0.58	-8.15 percentage change Standard Deviation 0.73

PRIMARY outcome

Timeframe: Baseline

Baseline serum low-density lipoprotein size

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	21.62 nm Standard Deviation 1.87	21.72 nm Standard Deviation 2.1

PRIMARY outcome

Timeframe: Baseline to 8 weeks

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

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Dyslipidemia Measures	1.65 percentage change Standard Deviation 0.3	1.68 percentage change Standard Deviation 0.24

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Insulin Resistance Indices	-6.87 percentage change Standard Deviation 0.38	-7.65 percentage change Standard Deviation 1.25

SECONDARY outcome

Timeframe: Baseline

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

HOMA_IR is a scale where a higher number means worse outcome

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Insulin Resistance Indices	2.15 index score Standard Deviation 0.12	2.21 index score Standard Deviation 0.16

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Body Composition	43.2 % of total body weight Standard Deviation 5.8	45.6 % of total body weight Standard Deviation 4.9

SECONDARY outcome

Timeframe: Baseline to 8 weeks

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

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Body Composition	-8.7 percentage change Standard Deviation 2.1	-8.84 percentage change Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline

Baseline Pulse wave velocity

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Surrogate Markers of Vascular Endothelial Function	11 m/s Standard Deviation 1	11.2 m/s Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline to 8 weeks

Percentage Change in Pulse wave velocity

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Surrogate Markers of Vascular Endothelial Function	-2 percentage change Standard Deviation 1.5	-2 percentage change Standard Deviation 1.74

SECONDARY outcome

Timeframe: Baseline

The Augmentation Index a measure of peripheral arterial stiffness

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index	81.8 Percent Standard Deviation 7.98	88.7 Percent Standard Deviation 8.76

SECONDARY outcome

Timeframe: Baseline to 8 weeks

The Augmentation Index a measure of peripheral arterial stiffness

Outcome measures

Measure	Standard/Low Fat Diet Group n=15 Participants 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. Standard low fat diet: Diet with less than 20% total calorie intake from dietary fats	Carbohydrate Restricted Group n=15 Participants 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. Carbohydrate restricted group: Prescribed low carbohydrate diet with set recipes
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index	-27 percentage change Standard Error 1	-28.6 percentage change Standard Error 1.5

Adverse Events

Standard/Low Fat Diet Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carbohydrate Restricted Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bhuvana Sunil

University of Alabama at Birmingham

Phone: 2056389107

Email: dr.bhuvana.s@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place