Non-alcoholic Fatty-liver DiseaseSweet BevNCT01188083
Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
A study testing Fructose Drink and Glucose Drink in people with Non-alcoholic Fatty-liver Disease, run by Emory University at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic steatosis. 2. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Non-alcoholic Fatty-liver Disease
- What is being tested?
- Fructose Drink and Glucose Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2012
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- BMI > 85th %tile
- Self identified as Hispanic
- Age 11-18 years
- Baseline hepatic fat fraction >8%
- Self reported sugar beverage intake of at least 24 oz (equivalent to 3 sugar sweetened drinks per day).
Who cannot join
- Currently attempting weight gain or weight loss
- Cirrhosis visible on baseline MRI
- Renal insufficiency found on screening labs (creatinine > 2)
- Recent acute illness within past 4 weeks (defined by fever > 100.4ºF)
- Pregnancy
- Chronic illness requiring medication including diabetes
- Fasting glucose >120 on screening labs
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objectives:
- To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic steatosis.
- To determine if a 4 week reduction of dietary fructose improves fasting plasma triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as well as post-prandial levels in response to a high fructose meal.
- To determine if a 4 week reduction of dietary fructose improves markers of oxidative stress.
Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose beverages administered over 4 weeks.
Read the detailed description
Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects
Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age 11 to 18 years who are stable and not taking any chronic medication with no recent acute illnesses.
Definitions:
- BMI >95th %tile for age and gender
- Self-identified as Hispanic/Latino
- Baseline hepatic fat fraction > 10% (Have nonalcoholic fatty liver disease)
- Sweetened beverage intake of at least 24 ounces/day
- Conditions
- Non-alcoholic Fatty-liver Disease
- Being tested
- Fructose Drink, Glucose Drink
- Keywords
- NASH, non-alcoholic fatty-liver disease, Hispanic, overweight
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose DrinkDietary supplement
Fructose Based beverage 8 oz
Glucose DrinkDietary supplement
Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fructose Drink | Experimental | Subject will drink 3-8oz drinks per day for 4 weeks Receives: Dietary Supplement: Fructose Drink |
| Glucose Drink | Experimental | Subject will drink 3-8oz drinks per day for 4 weeks Receives: Dietary Supplement: Glucose Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Fat
Measured: 2 & 4 Weeks
Secondary outcomes (1)
Plasma Triglycerides
Measured: 2 & 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJun 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty-liver DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Vos, MD, Emory University
- Investigators
- Miriam Vos, Md, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188083
- Sponsor's protocol ID
- IRB00007471
- Other IDs
- Emory-Vos-SweetBev
- Acronym
- Sweet Bev
- Status last verified
- Nov 2013
- First submitted
- 9 Jun 2010
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Holzberg JR, Jin R, Le NA, Ziegler TR, Brunt EM, McClain CJ, Konomi JV, Arteel GE, Vos MB. Plasminogen Activator Inhibitor-1 Predicts Quantity of Hepatic Steatosis Independent of Insulin Resistance and Body Weight. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):819-23. doi: 10.1097/MPG.0000000000001096.
PubMed 26704864
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
- ClinicalTrials.gov ID
- NCT01188083
- Acronym / sponsor ID
- Sweet Bev / IRB00007471
- Conditions
- Non-alcoholic Fatty-liver Disease
- Keywords
- NASH, non-alcoholic fatty-liver disease, Hispanic, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Aug 2010 (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.
Primary Objectives:
- To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic steatosis.
- To determine if a 4 week reduction of dietary fructose improves fasting plasma triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as well as post-prandial levels in response to a high fructose meal.
- To determine if a 4 week reduction of dietary fructose improves markers of oxidative stress.
Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose beverages administered over 4 weeks.
Detailed description
Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects
Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age 11 to 18 years who are stable and not taking any chronic medication with no recent acute illnesses.
Definitions:
- BMI >95th %tile for age and gender
- Self-identified as Hispanic/Latino
- Baseline hepatic fat fraction > 10% (Have nonalcoholic fatty liver disease)
- Sweetened beverage intake of at least 24 ounces/day
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fructose Drink | Experimental | Dietary Supplement: Fructose DrinkSubject will drink 3-8oz drinks per day for 4 weeks |
| Glucose Drink | Experimental | Dietary Supplement: Glucose DrinkSubject will drink 3-8oz drinks per day for 4 weeks |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- BMI > 85th %tile
- Self identified as Hispanic
- Age 11-18 years
- Baseline hepatic fat fraction >8%
- Self reported sugar beverage intake of at least 24 oz (equivalent to 3 sugar sweetened drinks per day).
Key exclusion criteria (7 listed)
- Currently attempting weight gain or weight loss
- Cirrhosis visible on baseline MRI
- Renal insufficiency found on screening labs (creatinine > 2)
- Recent acute illness within past 4 weeks (defined by fever > 100.4ºF)
- Pregnancy
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 |
|---|---|---|
| Fructose DrinkFructose Based beverage 8 oz | Dietary supplement | Fructose Drink |
| Glucose DrinkGlucose Based beverage 8 oz per drink x 3 per day x 4 weeks | Dietary supplement | Glucose Drink |
Primary outcome
Hepatic Fat
Time frame: 2 & 4 Weeks
1 secondary outcome
Plasma Triglycerides
Time frame: 2 & 4 Weeks
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 21 Nov 2013.
- Derived from this study: PubMed 26704864Holzberg JR, Jin R, Le NA, Ziegler TR, Brunt EM, McClain CJ, Konomi JV, Arteel GE, Vos MB. Plasminogen Activator Inhibitor-1 Predicts Quantity of Hepatic Steatosis Independent of Insulin Resistance and Body Weight. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):819-23. doi: 10.1097/MPG.0000000000001096.
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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.
Miriam Vos, Md principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose Drink and Glucose Drink in people with Non-alcoholic Fatty-liver Disease, run by Emory University 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 7 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 21 Nov 2013. 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 Fat (time frame: 2 & 4 Weeks). 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 NCT01188083, which also lists 1 linked publication.
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 21 Nov 2013.