Healthy Eating Through Reduction Of Excess Sugar

NCT02948647 | Completed DMC

• 1 other identifier: HS-11-00446
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine the effect of dietary sugar reduction in obese children and examine whether there are differential effects based on genotype of a single amino acid substitution in the PNPLA3 gene that is highly prevalent in Hispanics and associated with significantly elevated liver fat.

Conditions

NAFLD

Keywords

obesity; fatty liver; sugar; PNPLA3

Outcome Measures

Primary Outcomes (3)

• Total liver fat fraction by Magnetic resonance imaging (MRI) at baseline

  Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.

  Baseline

• Total liver fat fraction by Magnetic resonance imaging (MRI) at 12 weeks

  Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.

  12 weeks

• Change in total liver fat fraction by Magnetic resonance imaging (MRI) from baseline to 12 weeks

  Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.

  Baseline and 12 weeks

Secondary Outcomes (33)

• Liver fibrosis by Magnetic Resonance Enterography (MRE) at baseline

  Baseline

• Liver fibrosis by Magnetic Resonance Enterography (MRE) at 12 weeks

  12 weeks

• Change in Liver fibrosis by Magnetic Resonance Enterography (MRE) from baseline to 12 weeks

  Baseline and 12 weeks

• Total body fat, soft lean tissue, and bone mineral content by dual-energy x-ray absorptiometry (DXA) at baseline

  Baseline

• Total body fat, soft lean tissue, and bone mineral content by dual-energy x-ray absorptiometry (DXA) at 12 weeks

  12 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Will receive standard of care, which is general dietary advice

Intervention Group

EXPERIMENTAL

Will receive standard of care as well as sugar-reduction education

Other: Standard of care plus sugar-reduction education

Interventions

Standard of care plus sugar-reduction education OTHER

This is a 12-week intervention where subjects will be educated on how to monitor their added sugar consumption. They will be asked to eliminate consumption of sweetened beverages for the 12-week period and will be receiving a weekly delivery of water bottles to their homes to displace the sweetened beverages in their home environment.

Intervention Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ethnicity: This study is limited to Hispanics because of their higher risk of NAFLD, higher frequency (\~50%) of the at-risk PNPLA3 allele (G), and because no prior studies have targeted improvement in liver fat and NAFLD in this high-risk population. As with all of our ongoing studies, Hispanic ethnicity will be based on self-identity for the participants as well as their parents and grandparents.
• Gender: Males and females will be eligible for this study.
• Age: Children 12 to 18 years of age will be eligible. In our experience, children younger than around 10 years of age and greater than 18 years would require different intervention/counseling strategies. Therefore, we can develop a more consistent "age-neutral" approach if we limit the age range to 12-18 years.
• Weight status: Subjects will be eligible if they are obese, defined by a BMI \> 95th percentile for age and gender.

You may not qualify if:

• Diabetes: Presence of type 1 or 2 diabetes, as defined by fasting plasma glucose \> 126 mg/dl, or positive for diabetes related antibodies including ICA512 and GAD. Participants testing positive for diabetes will be referred for treatment. Subjects with pre-diabetes will be eligible for the study
• Pregnancy: Women who self-report as pregnant or obtain a positive pregnancy test result during Visit 1 will be excluded. Furthermore, should a woman become pregnant during the course of the intervention, she will be withdrawn from the study at that time and asked to no longer participate. This is in order to protect the mother and child from radiation involved with the DEXA scan and potential complications associated with a low-sugar diet.
• Medication: Taking any medications known to influence liver function, insulin action or lipid levels
• Self-prescribed dietary supplements: Taking any non-prescription supplements that could potentially affect liver function and liver fat (eg vitamin E or fish oils)
• Other metabolic diseases: Diagnosis of other syndromes or diseases that may influence insulin action and secretion (e.g., maturity-onset diabetes of the young, lipoatrophic diabetes, cystic fibrosis), or body composition and fat distribution (e.g. Cushing syndrome, Down syndrome, lipodystrophy)
• Other medical condition: Previously diagnosed with any major illness since birth (e.g. severe intrauterine growth retardation, chronic birth asphyxia, cancer)
• Familial hyperlipidemia: Patients with a family history of hyperlipidemia will be excluded, due to the particular genetic background of this disease, which may bias our results. Familial hyperlipidemia will be defined as LDL/cholesterol \> 160 mg/dL and/or triglycerides \> 200 mg/dL in both the participant AND at least one family member (first degree: parents or siblings).
• Participation in a weight-loss or exercise program: participants who have participated to a weight-loss or exercise program in the past three months will be excluded due to its potential effect on weight status.

Sponsors & Collaborators

• University of Southern California: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Diabetes & Obesity Research Institute

Los Angeles, California, 90033-9073, United States

Location

Related Publications (1)

• Schmidt KA, Jones RB, Rios C, Corona Y, Berger PK, Plows JF, Alderete TL, Fogel J, Hampson H, Hartiala JA, Cai Z, Allayee H, Nayak KS, Sinatra FR, Harlan G, Pickering TA, Salvy SJ, Mack WJ, Kohli R, Goran MI. Clinical Intervention to Reduce Dietary Sugar Does Not Affect Liver Fat in Latino Youth, Regardless of PNPLA3 Genotype: A Randomized Controlled Trial. J Nutr. 2022 Jul 6;152(7):1655-1665. doi: 10.1093/jn/nxac046.

  PMID: 35218194 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Fatty Liver

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael I Goran

  University of Southern California; Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 28, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)