Metabolic SyndromeNCT01371396
Effect of Dietary Macronutrient Composition
A study testing Low-fat diet and Low-carbohydrate diet in people with Metabolic Syndrome and Non-alcoholic Fatty Liver Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- Low-fat diet and Low-carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2007to 31 Dec 2013
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated serum ALT or metabolic syndrome
- African American or Hispanic
- Nondiabetic
- Men or women
- Smokers and nonsmokers
- Pre- and post-menopausal (+/- HRT)
Show all 9Show fewer
- Stable body weight
- Age 20-65 years
- BMI between 25-45 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Nutrition
Dallas, Texas, 75390-9052
About this study
Official title: Effect of Dietary Macronutrient Composition on Liver Substrate Metabolism
The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease.
Read the detailed description
Obesity is a major factor driving the increased prevalence of hepatic steatosis in the US. However, little is known regarding the relationship between dietary intake and hepatic fat deposition or about the factors that promote loss of hepatic steatosis. Here, the investigators will determine how differences in dietary composition affect the development and regression of fatty liver. The investigators hypothesize that Hispanic subjects with metabolic syndrome will have higher liver fat synthesis rates compared to African American subjects.
Using detailed in vivo, serial measurements of fuel metabolism (GC/MS and NMR) fatty acid metabolism will be measured in the liver and periphery. This will be the first study in which these two methodologies are used together to assess both glucose and fatty acid metabolism in the same subjects. Subjects will be tested before and after a dietary weight-loss intervention producing 6% body weight loss over 5 months.
The specific aims are as follows:
AIM 1: Determine the contribution of peripheral and dietary fat to liver-TG in Hispanics and African Americans with metabolic syndrome.
Hypothesis: De novo lipogenesis will contribute to liver-TG in greater quantities compared to African Americans.
AIM 2: Determine the effects of low-CHO and low-fat diets on liver fat regression.
Hypothesis: Compared to a low-fat diet, a low-CHO diet will markedly decrease markers of inflammation coincident with greater improvements in insulin sensitivity as assessed by an intravenous glucose tolerance test.
- Being tested
- Low-fat diet, Low-carbohydrate diet
- Keywords
- Metabolic syndrome, Non-alcoholic fatty liver disease, Obesity Metabolism, Stable isotopes, Dietary weight loss
- Medical subject headings
- Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dietOther
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.
Low-carbohydrate dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hispanic subjects | Other | Subjects will identify as Hispanic ethnicity. Receives: Other: Low-fat diet; Other: Low-carbohydrate diet |
| African American subjects | Other | Subjects will self-identify as African American in origin. Receives: Other: Low-fat diet; Other: Low-carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline in fatty acid synthesis at 5 months
Secondary outcomes (2)
Dietary fatty acid clearance to liver
Using a dietary stable isotope we will quantitate fat absorption and recycling of fat through the liver.
Measured: Change from Baseline in dietary fat clearance at 5 months
Adipose fatty acid flux
A stable isotope is infused and the rate of adipose fatty acid release is calculated after analyzing blood samples.
Measured: Change from Baseline in adipose fat flux at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study start1 Sep 2007
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Parks, University of Texas Southwestern Medical Center
- Investigators
- Elizabeth J Parks, PhD, Principal investigator, UTSW Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371396
- Sponsor's protocol ID
- 5RL-1DK081187
- Status last verified
- Feb 2019
- First submitted
- 7 Jun 2011
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22045665Ramos-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.
PubMed 21820684Sunny 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.
PubMed 22152305Satapati 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.
PubMed 27035816Lee 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.
PubMed 25527748Lambert 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.
PubMed 27152153Lambert 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.
PubMed 40309768Ramos-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.
PubMed 22723441
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Macronutrient Composition on Liver Substrate Metabolism
- ClinicalTrials.gov ID
- NCT01371396
- Acronym / sponsor ID
- 5RL-1DK081187
- Keywords
- Metabolic syndrome, Non-alcoholic fatty liver disease, Obesity Metabolism, Stable isotopes, Dietary weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2007 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand why Hispanics who are overweight have a higher incidence of fatty liver disease.
Detailed description
Obesity is a major factor driving the increased prevalence of hepatic steatosis in the US. However, little is known regarding the relationship between dietary intake and hepatic fat deposition or about the factors that promote loss of hepatic steatosis. Here, the investigators will determine how differences in dietary composition affect the development and regression of fatty liver. The investigators hypothesize that Hispanic subjects with metabolic syndrome will have higher liver fat synthesis rates compared to African American subjects.
Using detailed in vivo, serial measurements of fuel metabolism (GC/MS and NMR) fatty acid metabolism will be measured in the liver and periphery. This will be the first study in which these two methodologies are used together to assess both glucose and fatty acid metabolism in the same subjects. Subjects will be tested before and after a dietary weight-loss intervention producing 6% body weight loss over 5 months.
The specific aims are as follows:
AIM 1: Determine the contribution of peripheral and dietary fat to liver-TG in Hispanics and African Americans with metabolic syndrome.
Hypothesis: De novo lipogenesis will contribute to liver-TG in greater quantities compared to African Americans.
AIM 2: Determine the effects of low-CHO and low-fat diets on liver fat regression.
Hypothesis: Compared to a low-fat diet, a low-CHO diet will markedly decrease markers of inflammation coincident with greater improvements in insulin sensitivity as assessed by an intravenous glucose tolerance test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hispanic subjects | Other | Other: Low-fat diet, Other: Low-carbohydrate dietSubjects will identify as Hispanic ethnicity. |
| African American subjects | Other | Other: Low-fat diet, Other: Low-carbohydrate dietSubjects will self-identify as African American in origin. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Elevated serum ALT or metabolic syndrome
- African American or Hispanic
- Nondiabetic
- Men or women
- Smokers and nonsmokers
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-fat dietThe 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. | Other | African American subjects, Hispanic subjects |
| Low-carbohydrate dietThe 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. | Other | African American subjects, Hispanic subjects |
Primary outcome
de novo lipogenesis
Time frame: Change from Baseline in fatty acid synthesis at 5 months
In vivo measurement is made of liver fatty acid synthesis using stable isotope administration and analysis of plasma samples by GS/MS
2 secondary outcomes
Dietary fatty acid clearance to liver
Time frame: Change from Baseline in dietary fat clearance at 5 months
Adipose fatty acid flux
Time frame: Change from Baseline in adipose fat flux at 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Results publication: PubMed 22045665Shetty 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.
- Results publication: PubMed 21820684Ramos-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.
- Results publication: PubMed 22152305Sunny 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.
- Results publication: PubMed 27035816Satapati 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.
- Results publication: PubMed 25527748Lee 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.
- Results publication: PubMed 27152153Lambert 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.
- Derived from this study: PubMed 40309768Lambert 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.
- Derived from this study: PubMed 22723441Ramos-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth J Parks, PhD principal investigator
UTSW Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fat diet and Low-carbohydrate diet in people with Metabolic Syndrome and Non-alcoholic Fatty Liver Disease, run by University of Texas Southwestern Medical Center 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 9 inclusion and 5 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 6 Feb 2019. 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?
de novo lipogenesis (time frame: Change from Baseline in fatty acid synthesis at 5 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 NCT01371396, which also lists 8 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 6 Feb 2019.