Effect of Dietary Macronutrient Composition
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2013
CompletedFebruary 6, 2019
February 1, 2019
6.3 years
June 7, 2011
February 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
de novo lipogenesis
In vivo measurement is made of liver fatty acid synthesis using stable isotope administration and analysis of plasma samples by GS/MS
Change from Baseline in fatty acid synthesis at 5 months
Secondary Outcomes (2)
Dietary fatty acid clearance to liver
Change from Baseline in dietary fat clearance at 5 months
Adipose fatty acid flux
Change from Baseline in adipose fat flux at 5 months
Study Arms (2)
Hispanic subjects
OTHERSubjects will identify as Hispanic ethnicity.
African American subjects
OTHERSubjects will self-identify as African American in origin.
Interventions
The subject will consume a diet that is calorically restricted to cause at least a 6% body weight loss over 4 months. Fat will make up less than 30% of dietary energy.
The diet will be restricted in energy to cause at least a 6% loss of body weight over a 4 month period. Carbohydrate will provide less than 40% of total dietary energy.
Eligibility Criteria
You may qualify if:
- Elevated serum ALT or metabolic syndrome
- African American or Hispanic
- Nondiabetic
- Men or women
- Smokers and nonsmokers
- Pre- and post-menopausal (+/- HRT)
- Stable body weight
- Age 20-65 years
- BMI between 25-45 kg/m2
You may not qualify if:
- Diabetes or Pregnancy
- Ethanol intake: males \> 140 g/week, females \> 70 g/week
- Chronic hepatitis B or chronic hepatitis C
- Hemochromatosis or Wilson's Disease
- Autoimmune hepatitis or primary biliary cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Human Nutrition
Dallas, Texas, 75390-9052, United States
Related Publications (8)
Shetty S, Ramos-Roman MA, Cho YR, Brown J, Plutzky J, Muise ES, Horton JD, Scherer PE, Parks EJ. Enhanced fatty acid flux triggered by adiponectin overexpression. Endocrinology. 2012 Jan;153(1):113-22. doi: 10.1210/en.2011-1339. Epub 2011 Nov 1.
PMID: 22045665RESULTRamos-Roman MA, Sweetman L, Valdez MJ, Parks EJ. Postprandial changes in plasma acylcarnitine concentrations as markers of fatty acid flux in overweight and obesity. Metabolism. 2012 Feb;61(2):202-12. doi: 10.1016/j.metabol.2011.06.008. Epub 2011 Aug 5.
PMID: 21820684RESULTSunny NE, Parks EJ, Browning JD, Burgess SC. Excessive hepatic mitochondrial TCA cycle and gluconeogenesis in humans with nonalcoholic fatty liver disease. Cell Metab. 2011 Dec 7;14(6):804-10. doi: 10.1016/j.cmet.2011.11.004.
PMID: 22152305RESULTSatapati S, Kucejova B, Duarte JA, Fletcher JA, Reynolds L, Sunny NE, He T, Nair LA, Livingston KA, Fu X, Merritt ME, Sherry AD, Malloy CR, Shelton JM, Lambert J, Parks EJ, Corbin I, Magnuson MA, Browning JD, Burgess SC. Mitochondrial metabolism mediates oxidative stress and inflammation in fatty liver. J Clin Invest. 2016 Apr 1;126(4):1605. doi: 10.1172/JCI86695. Epub 2016 Apr 1. No abstract available.
PMID: 27035816RESULTLee JJ, Lambert JE, Hovhannisyan Y, Ramos-Roman MA, Trombold JR, Wagner DA, Parks EJ. Palmitoleic acid is elevated in fatty liver disease and reflects hepatic lipogenesis. Am J Clin Nutr. 2015 Jan;101(1):34-43. doi: 10.3945/ajcn.114.092262. Epub 2014 Nov 19.
PMID: 25527748RESULTLambert JE, Parks EJ. Getting the label in: practical research strategies for tracing dietary fat. Int J Obes Suppl. 2012 Dec;2(Suppl 2):S43-50. doi: 10.1038/ijosup.2012.22. Epub 2012 Dec 11.
PMID: 27152153RESULTLambert JE, Ramos-Roman MA, Valdez MJ, Browning JD, Rogers T, Parks EJ. Weight loss in MASLD restores the balance of liver fatty acid sources. J Clin Invest. 2025 May 1;135(9):e174233. doi: 10.1172/JCI174233. eCollection 2025 May 1.
PMID: 40309768DERIVEDRamos-Roman MA, Lapidot SA, Phair RD, Parks EJ. Insulin activation of plasma nonesterified fatty acid uptake in metabolic syndrome. Arterioscler Thromb Vasc Biol. 2012 Aug;32(8):1799-808. doi: 10.1161/ATVBAHA.112.250019. Epub 2012 Jun 21.
PMID: 22723441DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth J Parks, PhD
UTSW Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 10, 2011
Study Start
September 1, 2007
Primary Completion
December 31, 2013
Study Completion
December 31, 2013
Last Updated
February 6, 2019
Record last verified: 2019-02