Metabolic SyndromeNCT03937960
Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome
A study testing Carbohydrate restricted group and Standard low fat diet in people with Metabolic Syndrome and Obesity, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Metabolic Syndrome, Obesity, Dyslipidemias
- What is being tested?
- Carbohydrate restricted group and Standard low fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bhuvana Sunil
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
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.
Read the 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
- Metabolic Syndrome, Obesity, Dyslipidemias
- Being tested
- Carbohydrate restricted group, Standard low fat diet
- Keywords
- Dietary intervention, Anthropometric measure, Lipid profile, Augmentation Index, Flow mediated dilation, DXA scan, Nuclear magnetic resonance lipid profile
- Medical subject headings
- Metabolic Syndrome, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate restricted groupOther
Prescribed low carbohydrate diet with set recipes
Standard low fat dietOther
Diet with less than 20% total calorie intake from dietary fats
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate restricted group | Active comparator | 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. Receives: Other: Carbohydrate restricted group |
| Standard/Low fat diet group | Active comparator | 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. Receives: Other: Standard low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyslipidemia Measures
Baseline concentration of serum High-density Lipoprotein level in mg/dL
Measured: Baseline
Dyslipidemia Measures
Change in concentration of serum High density Lipoprotein in mg/dL
Measured: Baseline to 8 weeks
Dyslipidemia Measures
Baseline concentration of serum Triglyceride level in mg/dL
Measured: Baseline
Dyslipidemia Measures
Change in concentration of serum Triglyceride level in mg/dL
Measured: Baseline to 8 weeks
Dyslipidemia Measures
Baseline concentration of serum lipoprotein particle number
Measured: Baseline
Dyslipidemia Measures
Change in concentration of serum lipoprotein particle number in percentage
Measured: Baseline to 8 weeks
Dyslipidemia Measures
Baseline concentration of serum lipoprotein particle concentration
Measured: Baseline
Dyslipidemia Measures
Change in concentration of serum lipoprotein particle concentration in percentage
Measured: Baseline to 8 weeks
Dyslipidemia Measures
Baseline total serum high density lipoprotein particle number
Measured: Baseline
Dyslipidemia Measures
percentage Change in concentration of serum high density lipoprotein particle
Measured: Baseline to 8 weeks
Dyslipidemia Measures
Baseline concentration of serum small low-density lipoprotein particle concentration
Measured: Baseline
Dyslipidemia Measures
Percentage change in concentration of serum small low density lipoprotein particle
Measured: Baseline to 8 weeks
Dyslipidemia Measures
Baseline serum low-density lipoprotein size
Measured: Baseline
Dyslipidemia Measures
Percentage change in concentration of serum small low-density lipoprotein size
Measured: Baseline to 8 weeks
Insulin Resistance Indices
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
Measured: Baseline to 8 weeks
Secondary outcomes (7)
Insulin Resistance Indices
Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA_IR is a scale where a higher number means worse outcome
Measured: Baseline
Body Composition
Dual-energy X-ray absorptiometry (DXA) - measure of body fat
Measured: Baseline
Body Composition
Percent Change in Dual-energy X-ray absorptiometry (DXA) body fat
Measured: Baseline to 8 weeks
Surrogate Markers of Vascular Endothelial Function
Baseline Pulse wave velocity
Measured: Baseline
Surrogate Markers of Vascular Endothelial Function
Percentage Change in Pulse wave velocity
Measured: Baseline to 8 weeks
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
The Augmentation Index a measure of peripheral arterial stiffness
Measured: Baseline
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
The Augmentation Index a measure of peripheral arterial stiffness
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jan 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhuvana Sunil, University of Alabama at Birmingham
- Investigators
- Bhuvana Sunil, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937960
- Sponsor's protocol ID
- IRB-300002816
- Other IDs
- P30DK056336
- Status last verified
- Nov 2022
- First submitted
- 24 Apr 2019
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carbohydrate Restricted Versus Standard Low Fat Diet in the Treatment of Dyslipidemia in Children With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03937960
- Acronym / sponsor ID
- IRB-300002816
- Conditions
- Metabolic Syndrome, Obesity, Dyslipidemias
- Keywords
- Dietary intervention, Anthropometric measure, Lipid profile, Augmentation Index, Flow mediated dilation, DXA scan, Nuclear magnetic resonance lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate restricted group | Active comparator | Other: Carbohydrate restricted groupThis 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. |
| Standard/Low fat diet group | Active comparator | Other: Standard low fat dietThe 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate restricted groupPrescribed low carbohydrate diet with set recipes | Other | Carbohydrate restricted group |
| Standard low fat dietDiet with less than 20% total calorie intake from dietary fats | Other | Standard/Low fat diet group |
Primary outcome
Dyslipidemia Measures
Time frame: Baseline
Baseline concentration of serum High-density Lipoprotein level in mg/dL
Dyslipidemia Measures
Time frame: Baseline to 8 weeks
Change in concentration of serum High density Lipoprotein in mg/dL
Dyslipidemia Measures
Time frame: Baseline
Baseline concentration of serum Triglyceride level in mg/dL
Dyslipidemia Measures
Time frame: Baseline to 8 weeks
Change in concentration of serum Triglyceride level in mg/dL
Dyslipidemia Measures
Time frame: Baseline
Baseline concentration of serum lipoprotein particle number
Dyslipidemia Measures
Time frame: Baseline to 8 weeks
Change in concentration of serum lipoprotein particle number in percentage
Dyslipidemia Measures
Time frame: Baseline
Baseline concentration of serum lipoprotein particle concentration
Dyslipidemia Measures
Time frame: Baseline to 8 weeks
Change in concentration of serum lipoprotein particle concentration in percentage
Dyslipidemia Measures
Time frame: Baseline
Baseline total serum high density lipoprotein particle number
Dyslipidemia Measures
Time frame: Baseline to 8 weeks
percentage Change in concentration of serum high density lipoprotein particle
Dyslipidemia Measures
Time frame: Baseline
Baseline concentration of serum small low-density lipoprotein particle concentration
Dyslipidemia Measures
Time frame: Baseline to 8 weeks
Percentage change in concentration of serum small low density lipoprotein particle
Dyslipidemia Measures
Time frame: Baseline
Baseline serum low-density lipoprotein size
Dyslipidemia Measures
Time frame: Baseline to 8 weeks
Percentage change in concentration of serum small low-density lipoprotein size
Insulin Resistance Indices
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
7 secondary outcomes
Insulin Resistance Indices
Time frame: Baseline
Body Composition
Time frame: Baseline
Body Composition
Time frame: Baseline to 8 weeks
Surrogate Markers of Vascular Endothelial Function
Time frame: Baseline
Surrogate Markers of Vascular Endothelial Function
Time frame: Baseline to 8 weeks
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
Time frame: Baseline
Surrogate Markers of Vascular Endothelial Function as Measured by Augmentation Index
Time frame: Baseline to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhuvana Sunil, MD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate restricted group and Standard low fat diet in people with Metabolic Syndrome and Obesity, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyslipidemia Measures (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.