Non-Alcoholic Fatty Liver DiseasePhase 4NCT03444233
Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.
A Phase 4 study testing Diet in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by University of Hohenheim.
Trial summary
The purpose of this study is to investigate how a high-fructose diet, either by high fructose intake from complex, natural foods or by fortifying the diet with corn syrup, affects the metabolism. Furthermore, it will be investigate if there are differences between obese and normal weight participants. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2009to 15 Oct 2009
- Phase
- Phase 4
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, aged between 20 and 30 years
- normal weighted (BMI ≤ 25 kg/m2) and obese (BMI 35-50 kg/m2)
- written informed consent
- At initial medical examination an anamnesis, physical examination, blood sample collection (10 ml) was performed to check for eligibility. Furthermore, a hydrogen breath test was performed to detect potential fructose intolerance
Who cannot join
- smoking,
- fructose intolerance/ -malabsorption,
- pregnancy
- chronic gastrointestinal diseases (e.g. chronic inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.),
- operation on the gastrointestinal tract (exclusively appendectomy)
- anemia,
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- hepatic or renal disease
- diabetes mellitus
- consuming illnesses (e.g. cancer, acquired immunodeficiency syndrome (AIDS)) - drug intake affecting lipid or glucose metabolism (cholesterol- or glucose reducing or antihypertensive drugs, steroids, L-Thyroxin, antidepressants, weight reducing drugs).
About this study
The purpose of this study is to investigate how a high-fructose diet, either by high fructose intake from complex, natural foods or by fortifying the diet with corn syrup, affects the metabolism. Furthermore, it will be investigate if there are differences between obese and normal weight participants.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Being tested
- Diet
- 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.
DietOther
Also called C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld
7 days fruit-rich diet, 7 days HFCS-rich diet
| Study group | Role | What they receive |
|---|---|---|
| low f1 diet | Experimental | low fructose diet week 1 Receives: Other: Diet |
| fruit rich diet | Experimental | fruit rich diet week 2 Receives: Other: Diet |
| low f2 diet | Experimental | low fructose diet week 3 Receives: Other: Diet |
| HFCS rich diet | Experimental | HFCS rich diet week 4 Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolite concentration
The primary endpoint is the change of metabolite concentration after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Secondary outcomes (19)
fatty liver index
Change in fatty liver index after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Non-alcoholic fatty liver disease (NAFLD)
Change in the classification of non-alcoholic fatty liver disease (NAFLD) based on ultrasound after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Body weight
Change from baseline in body weight after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Blood pressure (systolic and diastolic)
Change in blood pressure (systolic and diastolic) after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
GGT
Change in GGT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
GOT
Change in GOT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
GPT
Change in GPT after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
AP
Change in AP after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Triglycerides
Change in triglycerides after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
HDL
Change in HDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
LDL
Change in LDL after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Fasting glucose
Change in fasting glucose after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
BSR
Change in BSR after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Kreatinine
Change in Kreatinine after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Uric acid
Change in uric acid after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Urea
Change in urea after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Cholesterol
Change in cholesterol after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Ghrelin
Change in ghrelin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Leptin
Change in leptin after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
Measured: Participants will be followed for the time of four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start15 Aug 2009
- Primary completion15 Oct 2009
- Study completion15 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan C Bischoff, Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444233
- Sponsor's protocol ID
- Fructose Study
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.
- ClinicalTrials.gov ID
- NCT03444233
- Acronym / sponsor ID
- Fructose Study
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 15 Aug 2009 (actual)
- Primary completion
- 15 Oct 2009 (actual)
- Study completion
- 15 Oct 2009 (actual)
- First posted
- 23 Feb 2018 (actual)
- 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 investigate how a high-fructose diet, either by high fructose intake from complex, natural foods or by fortifying the diet with corn syrup, affects the metabolism. Furthermore, it will be investigate if there are differences between obese and normal weight participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low f1 diet | Experimental | Other: Dietlow fructose diet week 1 |
| fruit rich diet | Experimental | Other: Dietfruit rich diet week 2 |
| low f2 diet | Experimental | Other: Dietlow fructose diet week 3 |
| HFCS rich diet | Experimental | Other: DietHFCS rich diet week 4 |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults, aged between 20 and 30 years
- normal weighted (BMI ≤ 25 kg/m2) and obese (BMI 35-50 kg/m2)
- written informed consent
- At initial medical examination an anamnesis, physical examination, blood sample collection (10 ml) was performed to check for eligibility. Furthermore, a hydrogen breath test was performed to detect potential fructose intolerance
Key exclusion criteria (9 listed)
- smoking,
- fructose intolerance/ -malabsorption,
- pregnancy
- chronic gastrointestinal diseases (e.g. chronic inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.),
- operation on the gastrointestinal tract (exclusively appendectomy)
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 |
|---|---|---|
| DietAlso: C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld7 days fruit-rich diet, 7 days HFCS-rich diet | Other | HFCS rich diet, fruit rich diet, low f1 diet, low f2 diet |
Primary outcome
metabolite concentration
Time frame: Participants will be followed for the time of four weeks.
The primary endpoint is the change of metabolite concentration after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
19 secondary outcomes
fatty liver index
Time frame: Participants will be followed for the time of four weeks.
Non-alcoholic fatty liver disease (NAFLD)
Time frame: Participants will be followed for the time of four weeks.
Body weight
Time frame: Participants will be followed for the time of four weeks.
Blood pressure (systolic and diastolic)
Time frame: Participants will be followed for the time of four weeks.
GGT
Time frame: Participants will be followed for the time of four weeks.
GOT
Time frame: Participants will be followed for the time of four weeks.
GPT
Time frame: Participants will be followed for the time of four weeks.
AP
Time frame: Participants will be followed for the time of four weeks.
Triglycerides
Time frame: Participants will be followed for the time of four weeks.
HDL
Time frame: Participants will be followed for the time of four weeks.
LDL
Time frame: Participants will be followed for the time of four weeks.
Fasting glucose
Time frame: Participants will be followed for the time of four weeks.
BSR
Time frame: Participants will be followed for the time of four weeks.
Kreatinine
Time frame: Participants will be followed for the time of four weeks.
Uric acid
Time frame: Participants will be followed for the time of four weeks.
Urea
Time frame: Participants will be followed for the time of four weeks.
Cholesterol
Time frame: Participants will be followed for the time of four weeks.
Ghrelin
Time frame: Participants will be followed for the time of four weeks.
Leptin
Time frame: Participants will be followed for the time of four 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 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Stephan C Bischoff principal investigator
University of Hohenheim
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diet in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by University of Hohenheim.
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 4 inclusion and 9 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
metabolite concentration (time frame: Participants will be followed for the time of four weeks.). 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 23 Feb 2018; AzTrials last refreshed its copy on 7 Nov 2026.