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

Non-alcoholic Fatty Liver Disease Clinical Trial

— NAFLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116192
• Other study ID #: K12HD055894
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• Experimental: Low-fructose, reduced carbohydrate diet
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 Diet
Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat

Locations

Country	Name	City	State
United States	Research Park Clinic	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Chitturi S, Farrell GC. Etiopathogenesis of nonalcoholic steatohepatitis. Semin Liver Dis. 2001;21(1):27-41. Review. — View Citation

Clark JM. The epidemiology of nonalcoholic fatty liver disease in adults. J Clin Gastroenterol. 2006 Mar;40 Suppl 1:S5-10. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Dunn W, Schwimmer JB. The obesity epidemic and nonalcoholic fatty liver disease in children. Curr Gastroenterol Rep. 2008 Feb;10(1):67-72. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Lytle LA, Murray DM, Evenson KR, Moody J, Pratt CA, Metcalfe L, Parra-Medina D. Mediators affecting girls' levels of physical activity outside of school: findings from the trial of activity in adolescent girls. Ann Behav Med. 2009 Oct;38(2):124-36. doi: 10.1007/s12160-009-9127-2. Epub 2009 Dec 12. — View Citation

McCullough AJ. The clinical features, diagnosis and natural history of nonalcoholic fatty liver disease. Clin Liver Dis. 2004 Aug;8(3):521-33, viii. Review. — View Citation

Miller WR. What really drives change? Addiction. 1993 Nov;88(11):1479-80. — View Citation

Nomura K, Yamanouchi T. The role of fructose-enriched diets in mechanisms of nonalcoholic fatty liver disease. J Nutr Biochem. 2012 Mar;23(3):203-8. doi: 10.1016/j.jnutbio.2011.09.006. Epub 2011 Nov 29. Review. — View Citation

Park YK, Yetley EA. Intakes and food sources of fructose in the United States. Am J Clin Nutr. 1993 Nov;58(5 Suppl):737S-747S. doi: 10.1093/ajcn/58.5.737S. Review. — View Citation

Pozzato C, Verduci E, Scaglioni S, Radaelli G, Salvioni M, Rovere A, Cornalba G, Riva E, Giovannini M. Liver fat change in obese children after a 1-year nutrition-behavior intervention. J Pediatr Gastroenterol Nutr. 2010 Sep;51(3):331-5. doi: 10.1097/MPG.0b013e3181d70468. — View Citation

Sallis JF, McKenzie TL, Conway TL, Elder JP, Prochaska JJ, Brown M, Zive MM, Marshall SJ, Alcaraz JE. Environmental interventions for eating and physical activity: a randomized controlled trial in middle schools. Am J Prev Med. 2003 Apr;24(3):209-17. — View Citation

Schwimmer JB. Definitive diagnosis and assessment of risk for nonalcoholic fatty liver disease in children and adolescents. Semin Liver Dis. 2007 Aug;27(3):312-8. Review. — View Citation

Szczepaniak LS, Nurenberg P, Leonard D, Browning JD, Reingold JS, Grundy S, Hobbs HH, Dobbins RL. Magnetic resonance spectroscopy to measure hepatic triglyceride content: prevalence of hepatic steatosis in the general population. Am J Physiol Endocrinol Metab. 2005 Feb;288(2):E462-8. Epub 2004 Aug 31. — View Citation

Williams KH, Shackel NA, Gorrell MD, McLennan SV, Twigg SM. Diabetes and nonalcoholic Fatty liver disease: a pathogenic duo. Endocr Rev. 2013 Feb;34(1):84-129. doi: 10.1210/er.2012-1009. Epub 2012 Dec 13. Review. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF		6 months
Secondary	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	6 months
Secondary	PNPLA3 genotype		6 months
Secondary	Novel free breathing hepatic MR PDFF protocol		6 months