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Non-alcoholic Fatty Liver DiseaseNAFLDNCT02116192

Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents

A study testing Experimental: Low-fructose, reduced carbohydrate diet and General Healthy Diet in people with Non-alcoholic Fatty Liver Disease, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to join the study. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Non-alcoholic Fatty Liver Disease
What is being tested?
Experimental: Low-fructose, reduced carbohydrate diet and General Healthy Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
Apr 2014to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

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 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 11-17 years of age
  • BMI >95%tile for age and sex
  • Being seen for an initial clinic visit at the UW Pediatric Fitness Clinic
  • Parent willing to participate in study

Who cannot join

  • History of chronic disease that effects hepatic or renal function including: Type 1 or Type 2 diabetes mellitus, known liver disease or other chronic illness.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Park Clinic

    Madison, Wisconsin, 53711

Other trials in United States

About this study

This research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to join the study. Patients who agree to participate in the study will be randomized into either the intervention group or the control group. The intervention group will follow a low-fructose diet. In addition, participants will be asked to return to the clinic for 4 follow-up visits during a 6-month interval.

Read the detailed description

This will be a prospective, randomized, controlled trial for obese adolescents. Sixty obese youth (male and female), age 11-17 years with BMI >95 %tile for age and sex and one parent/guardian will be recruited for inclusion into the study at an initial pediatric fitness clinic visit. Consented subjects will be stratified by gender and ethnicity and randomized into low fructose or standard weight loss dietary intervention groups.

Being tested
Experimental: Low-fructose, reduced carbohydrate diet, General Healthy Diet
Keywords
Non-alcoholic Fatty Liver Disease, Adolescent
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Low-fructose, reduced carbohydrate dietBehavioural

    Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat)

    ● Aim for less than 25g fructose daily.

  • General Healthy DietBehavioural

    Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat

Study groups in NCT02116192
Study groupRoleWhat they receive
General Healthy DietActive comparatorControl: General Healthy Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat)
Receives: Behavioral: General Healthy Diet
Low-fructose, reduced carbohydrate dietExperimentalIntervention: Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat) ● Aim for less than 25g fructose daily.
Receives: Behavioral: Experimental: Low-fructose, reduced carbohydrate diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF

    Measured: 6 months

Secondary outcomes (3)

  1. Metabolic biomarkers

    Including waist circumference (WC), blood pressure (BP), insulin resistance measured by homeostasis model assessment (HOMA-IR), lipids, ALT, androgens, and visceral and subcutaneous adiposity (by MR PDFF), and cardiovascular fitness (sub-maxVO2 test), in low carbohydrate/low fructose and standard weight-reduction diet groups

    Measured: 6 months

  2. PNPLA3 genotype

    Measured: 6 months

  3. Novel free breathing hepatic MR PDFF protocol

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJul 2016
  4. Study completionOct 2017

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02116192
Sponsor's protocol ID
K12HD055894
Acronym
NAFLD
Status last verified
Oct 2018
First submitted
14 Apr 2014
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • American Gastroenterological Association. American Gastroenterological Association medical position statement: nonalcoholic fatty liver disease. Gastroenterology. 2002 Nov;123(5):1702-4. doi: 10.1053/gast.2002.36569. No abstract available.

    PubMed 12404244

  • Assy N, Nasser G, Kamayse I, Nseir W, Beniashvili Z, Djibre A, Grosovski M. Soft drink consumption linked with fatty liver in the absence of traditional risk factors. Can J Gastroenterol. 2008 Oct;22(10):811-6. doi: 10.1155/2008/810961.

    PubMed 18925303

  • Brunt EM. Nonalcoholic steatohepatitis. Semin Liver Dis. 2004 Feb;24(1):3-20. doi: 10.1055/s-2004-823098.

    PubMed 15085483

  • Brunt EM. Pathology of nonalcoholic steatohepatitis. Hepatol Res. 2005 Oct;33(2):68-71. doi: 10.1016/j.hepres.2005.09.006. Epub 2005 Oct 7.

    PubMed 16214395

  • Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis. 2001;21(1):27-41. doi: 10.1055/s-2001-12927.

    PubMed 11296694

  • Clark JM. The epidemiology of nonalcoholic fatty liver disease in adults. J Clin Gastroenterol. 2006 Mar;40 Suppl 1:S5-10. doi: 10.1097/01.mcg.0000168638.84840.ff.

    PubMed 16540768

  • Curtis VA, Carrel AL, Eickhoff JC, Allen DB. Gender and race influence metabolic benefits of fitness in children: a cross-sectional study. Int J Pediatr Endocrinol. 2012 Mar 15;2012(1):4. doi: 10.1186/1687-9856-2012-4.

    PubMed 22420715

  • Della Corte C, Alisi A, Saccari A, De Vito R, Vania A, Nobili V. Nonalcoholic fatty liver in children and adolescents: an overview. J Adolesc Health. 2012 Oct;51(4):305-12. doi: 10.1016/j.jadohealth.2012.01.010. Epub 2012 Mar 13.

    PubMed 22999829

  • Denzer C, Thiere D, Muche R, Koenig W, Mayer H, Kratzer W, Wabitsch M. Gender-specific prevalences of fatty liver in obese children and adolescents: roles of body fat distribution, sex steroids, and insulin resistance. J Clin Endocrinol Metab. 2009 Oct;94(10):3872-81. doi: 10.1210/jc.2009-1125. Epub 2009 Sep 22.

    PubMed 19773396

  • Dishman RK, Dunn AL, Sallis JF, Vandenberg RJ, Pratt CA. Social-cognitive correlates of physical activity in a multi-ethnic cohort of middle-school girls: two-year prospective study. J Pediatr Psychol. 2010 Mar;35(2):188-98. doi: 10.1093/jpepsy/jsp042. Epub 2009 May 25.

    PubMed 19468040

  • Dunn W, Schwimmer JB. The obesity epidemic and nonalcoholic fatty liver disease in children. Curr Gastroenterol Rep. 2008 Feb;10(1):67-72. doi: 10.1007/s11894-008-0011-1.

    PubMed 18417045

  • Feldstein AE, Charatcharoenwitthaya P, Treeprasertsuk S, Benson JT, Enders FB, Angulo P. The natural history of non-alcoholic fatty liver disease in children: a follow-up study for up to 20 years. Gut. 2009 Nov;58(11):1538-44. doi: 10.1136/gut.2008.171280. Epub 2009 Jul 21.

    PubMed 19625277

  • Kawasaki T, Igarashi K, Koeda T, Sugimoto K, Nakagawa K, Hayashi S, Yamaji R, Inui H, Fukusato T, Yamanouchi T. Rats fed fructose-enriched diets have characteristics of nonalcoholic hepatic steatosis. J Nutr. 2009 Nov;139(11):2067-71. doi: 10.3945/jn.109.105858. Epub 2009 Sep 23.

    PubMed 19776184

  • Loomba R, Sirlin CB, Schwimmer JB, Lavine JE. Advances in pediatric nonalcoholic fatty liver disease. Hepatology. 2009 Oct;50(4):1282-93. doi: 10.1002/hep.23119.

    PubMed 19637286

  • Ludwig J, Viggiano TR, McGill DB, Oh BJ. Nonalcoholic steatohepatitis: Mayo Clinic experiences with a hitherto unnamed disease. Mayo Clin Proc. 1980 Jul;55(7):434-8.

    PubMed 7382552

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Low-fructose, reduced carbohydrate diet and General Healthy Diet in people with Non-alcoholic Fatty Liver Disease, run by University of Wisconsin, Madison at 1 site 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 4 inclusion and 1 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02116192, which also lists 25 linked publications.

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 11 Oct 2018.

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