NCT03937960

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 22, 2022

Completed
Last Updated

December 22, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

April 24, 2019

Results QC Date

August 4, 2022

Last Update Submit

November 29, 2022

Conditions

Metabolic SyndromeObesityDyslipidemias

Keywords

Dietary interventionAnthropometric measureLipid profileAugmentation IndexFlow mediated dilationDXA scanNuclear magnetic resonance lipid profile

Outcome Measures

Primary Outcomes (15)

  • Dyslipidemia Measures

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

    Baseline

  • Dyslipidemia Measures

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

    Baseline to 8 weeks

  • Dyslipidemia Measures

    Baseline concentration of serum Triglyceride level in mg/dL

    Baseline

  • Dyslipidemia Measures

    Change in concentration of serum Triglyceride level in mg/dL

    Baseline to 8 weeks

  • Dyslipidemia Measures

    Baseline concentration of serum lipoprotein particle number

    Baseline

  • Dyslipidemia Measures

    Change in concentration of serum lipoprotein particle number in percentage

    Baseline to 8 weeks

  • Dyslipidemia Measures

    Baseline concentration of serum lipoprotein particle concentration

    Baseline

  • Dyslipidemia Measures

    Change in concentration of serum lipoprotein particle concentration in percentage

    Baseline to 8 weeks

  • Dyslipidemia Measures

    Baseline total serum high density lipoprotein particle number

    Baseline

  • Dyslipidemia Measures

    percentage Change in concentration of serum high density lipoprotein particle

    Baseline to 8 weeks

  • Dyslipidemia Measures

    Baseline concentration of serum small low-density lipoprotein particle concentration

    Baseline

  • Dyslipidemia Measures

    Percentage change in concentration of serum small low density lipoprotein particle

    Baseline to 8 weeks

  • Dyslipidemia Measures

    Baseline serum low-density lipoprotein size

    Baseline

  • Dyslipidemia Measures

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

    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

    Baseline to 8 weeks

Secondary Outcomes (7)

  • Insulin Resistance Indices

    Baseline

  • Body Composition

    Baseline

  • Body Composition

    Baseline to 8 weeks

  • Surrogate Markers of Vascular Endothelial Function

    Baseline

  • Surrogate Markers of Vascular Endothelial Function

    Baseline to 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: Standard low fat diet

Interventions

Carbohydrate restricted groupOTHER

Prescribed low carbohydrate diet with set recipes

Carbohydrate restricted group
Standard low fat dietOTHER

Diet with less than 20% total calorie intake from dietary fats

Standard/Low fat diet group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bhuvana Sunil

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeObesityDyslipidemias

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism Disorders

Results Point of Contact

Title
Dr. Bhuvana Sunil
Organization
University of Alabama at Birmingham
dr.bhuvana.s@gmail.com
2056389107

Study Officials

  • Bhuvana Sunil, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2019

First Posted

May 6, 2019

Study Start

January 1, 2020

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

December 22, 2022

Results First Posted

December 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)