Nonalcoholic Fatty Liver DiseaseFructoseNCT02018237
High Fructose Corn Syrup
A study testing High fructose corn syrup diet and Standard diet (low in high fructose corn syrup) in people with Nonalcoholic Fatty Liver Disease and Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Obesity
- What is being tested?
- High fructose corn syrup diet and Standard diet (low in high fructose corn syrup)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2016
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IHTG >6.5% or <5%
- BMI 30.0-45.0 kg/m²
- Sedentary
- Consume <10% calories from high fructose corn syrup
- Weight stable for previous 3 months
Who cannot join
- IHTG 5.1-7.9%
- Children
- Adults over 65 years
- Pregnant
- Lactating
- Exercise >1.5 hours/week
Show all 14Show fewer
- Hepatitis B or C
- Diabetes
- History of liver disease
- History of alcohol abuse
- Severe hypertriglyceridemia (>300 mg/dl)
- Smokers
- Anemia (Hemoglobin <10mg/dl)
- Not weight stable
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: The Effect of High Fructose Corn Syrup Feeding in Nonalcoholic Fatty Liver Disease
The purpose of this research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease. Eligible participants will be studied before and after eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn syrup) for four weeks.
- Conditions
- Nonalcoholic Fatty Liver Disease, Obesity
- Being tested
- High fructose corn syrup diet, Standard diet (low in high fructose corn syrup)
- Keywords
- Obesity, Nonalcoholic fatty liver disease, High fructose corn syrup
- Medical subject headings
- 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.
High fructose corn syrup dietBehavioural
Subjects will consume a high fructose corn syrup diet for 4 weeks. The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.
Standard diet (low in high fructose corn syrup)Behavioural
Subjects will consume a standard diet (low in high fructose corn syrup) for 4 weeks. The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.
| Study group | Role | What they receive |
|---|---|---|
| NAFLD | Active comparator | Subjects with nonalcoholic fatty liver disease (NAFLD) will complete baseline testing and then be assigned to either the high fructose corn syrup diet or the standard diet (low in high fructose corn syrup) for 4 weeks. Post intervention testing will be completed after the subjects have completed the 4 week diet intervention. Receives: Behavioral: High fructose corn syrup diet; Behavioral: Standard diet (low in high fructose corn syrup) |
| Non-NAFLD | Active comparator | Subjects without nonalcoholic fatty liver disease (Non-NAFLD) will complete baseline testing and then be fed a high fructose corn syrup diet for 4 weeks. Post intervention testing will be completed after the subjects have completed the 4 week diet intervention. Receives: Behavioral: High fructose corn syrup diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intrahepatic triglyceride (IHTG) content
Determine the effect of 4-week isocaloric diet high in high fructose corn syrup (HFCS) on IHTG content measured by magnetic resonance spectroscopy (MRS).
Measured: 4 weeks
Hepatic lipid metabolism
Determine the effect of 4-week isocaloric diet high in HFCS on hepatic lipid metabolism [de novo lipogenesis, very low density lipoprotein-triglyceride (VLDL-TG) and very low density lipoprotein-Apolipoprotein B100 (VLDL-ApoB) secretion rates] by using stable isotope tracer methods.
Measured: 4 weeks
Multi-organ insulin sensitivity
Determine the effect of 4-week isocaloric diet high in HFCS on multi-organ insulin sensitivity by using a one stage hyperinsulinemic euglycemic clamp procedure in conjunction with muscle and adipose tissue biopsies.
Measured: 4 weeks
Uric acid metabolism
Determine the effect of 4-week isocaloric diet high in HFCS on uric acid metabolism by measuring post-prandial serum uric acid concentrations and using stable isotope tracer method.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startMar 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelby A Sullivan, MD, Principal investigator, Associate Professor of MedicineSamuel Klein, MD, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018237
- Sponsor's protocol ID
- 2011-12111
- Acronym
- Fructose
- Status last verified
- Mar 2017
- First submitted
- 17 Dec 2013
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Fructose Corn Syrup Feeding in Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02018237
- Acronym / sponsor ID
- Fructose / 2011-12111
- Conditions
- Nonalcoholic Fatty Liver Disease, Obesity
- Keywords
- Obesity, Nonalcoholic fatty liver disease, High fructose corn syrup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Dec 2013 (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 research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease. Eligible participants will be studied before and after eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn syrup) for four weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD | Active comparator | Behavioral: High fructose corn syrup diet, Behavioral: Standard diet (low in high fructose corn syrup)Subjects with nonalcoholic fatty liver disease (NAFLD) will complete baseline testing and then be assigned to either the high fructose corn syrup diet or the standard diet (low in high fructose corn syrup) for 4 weeks. Post intervention testing will be completed after the subjects have completed the 4 week diet intervention. |
| Non-NAFLD | Active comparator | Behavioral: High fructose corn syrup dietSubjects without nonalcoholic fatty liver disease (Non-NAFLD) will complete baseline testing and then be fed a high fructose corn syrup diet for 4 weeks. Post intervention testing will be completed after the subjects have completed the 4 week diet intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IHTG >6.5% or <5%
- BMI 30.0-45.0 kg/m²
- Sedentary
- Consume <10% calories from high fructose corn syrup
- Weight stable for previous 3 months
Key exclusion criteria (14 listed)
- IHTG 5.1-7.9%
- Children
- Adults over 65 years
- Pregnant
- Lactating
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 |
|---|---|---|
| High fructose corn syrup dietSubjects will consume a high fructose corn syrup diet for 4 weeks. The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days. | Behavioural | NAFLD, Non-NAFLD |
| Standard diet (low in high fructose corn syrup)Subjects will consume a standard diet (low in high fructose corn syrup) for 4 weeks. The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days. | Behavioural | NAFLD |
Primary outcome
Change in intrahepatic triglyceride (IHTG) content
Time frame: 4 weeks
Determine the effect of 4-week isocaloric diet high in high fructose corn syrup (HFCS) on IHTG content measured by magnetic resonance spectroscopy (MRS).
Hepatic lipid metabolism
Time frame: 4 weeks
Determine the effect of 4-week isocaloric diet high in HFCS on hepatic lipid metabolism [de novo lipogenesis, very low density lipoprotein-triglyceride (VLDL-TG) and very low density lipoprotein-Apolipoprotein B100 (VLDL-ApoB) secretion rates] by using stable isotope tracer methods.
Multi-organ insulin sensitivity
Time frame: 4 weeks
Determine the effect of 4-week isocaloric diet high in HFCS on multi-organ insulin sensitivity by using a one stage hyperinsulinemic euglycemic clamp procedure in conjunction with muscle and adipose tissue biopsies.
Uric acid metabolism
Time frame: 4 weeks
Determine the effect of 4-week isocaloric diet high in HFCS on uric acid metabolism by measuring post-prandial serum uric acid concentrations and using stable isotope tracer method.
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 27 Mar 2017.
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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.
Shelby A Sullivan, MD principal investigator
Associate Professor of Medicine
Samuel Klein, MD principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fructose corn syrup diet and Standard diet (low in high fructose corn syrup) in people with Nonalcoholic Fatty Liver Disease and Obesity, run by Washington University School of Medicine 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 5 inclusion and 14 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 27 Mar 2017. 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?
Change in intrahepatic triglyceride (IHTG) content (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2017.