NAFLDUFOP-2NCT02458586
Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
A study testing Dietary intervention / counseling in people with NAFLD and Obesity, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Obesity, Prediabetes
- What is being tested?
- Dietary intervention / counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Nov 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- increased hepatic fat content (NAFLD)
- BMI between 30 and 35 kg/m²
Who cannot join
- diabetes
- severe cardiac, pulmonary or gastrointestinal disorders
- hepatic disorders other than NAFLD
- alcoholism
- medication with metabolic side or main effects (e.g. statins)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Institut for Human Nutrition; Department for Clinical Nutrition
Nuthetal, Brandenburg, 14458
Margrit Kemper, Dr. med., 033200 88 2775, margrit.kemper@dife.de
Silke Hornemann, 033200 88 2779, silke.hornemann@dife.de
About this study
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD).
The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD.
The study will compare two dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
Read the detailed description
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). A typical source for PUFAs are fish and certain plant oils, a source of almost pure MUFAs is olive oil.
The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD. The investigation focusses on male participants to avoid sex-related differences in the results.
The study will compare two isocaloric dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling (4 sessions). Metabolic outcome variables will be assessed with MR spectroscopy (liver fat), anthropometry (to check for stable weight and body composition) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
- Conditions
- NAFLD, Obesity, Prediabetes, Dyslipoproteinemia
- Being tested
- Dietary intervention / counseling
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Prediabetic State, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention / counselingDietary supplement
dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| MUFA | Placebo comparator | daily intake of 50 g of olive oil over a period of 8 weeks Receives: Dietary Supplement: Dietary intervention / counseling |
| PUFA | Active comparator | daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks Receives: Dietary Supplement: Dietary intervention / counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in liver fat content
change in liver fat content (MR spectroscopy and ultrasound)
Measured: 4 and 8 weeks
change in hepatic insulin sensitivity
change in hepatic insulin sensitivity (euglycemic hepatic clamp)
Measured: 8 weeks only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458586
- Sponsor's protocol ID
- UFOP-2
- Acronym
- UFOP-2
- Status last verified
- Nov 2016
- First submitted
- 28 May 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
- ClinicalTrials.gov ID
- NCT02458586
- Acronym / sponsor ID
- UFOP-2 / UFOP-2
- Conditions
- NAFLD, Obesity, Prediabetes, Dyslipoproteinemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.
- Study start
- May 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 1 Jun 2015 (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.
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD).
The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD.
The study will compare two dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
Detailed description
Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). A typical source for PUFAs are fish and certain plant oils, a source of almost pure MUFAs is olive oil.
The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD. The investigation focusses on male participants to avoid sex-related differences in the results.
The study will compare two isocaloric dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling (4 sessions). Metabolic outcome variables will be assessed with MR spectroscopy (liver fat), anthropometry (to check for stable weight and body composition) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUFA | Placebo comparator | Dietary Supplement: Dietary intervention / counselingdaily intake of 50 g of olive oil over a period of 8 weeks |
| PUFA | Active comparator | Dietary Supplement: Dietary intervention / counselingdaily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- increased hepatic fat content (NAFLD)
- BMI between 30 and 35 kg/m²
Key exclusion criteria (5 listed)
- diabetes
- severe cardiac, pulmonary or gastrointestinal disorders
- hepatic disorders other than NAFLD
- alcoholism
- medication with metabolic side or main effects (e.g. statins)
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 |
|---|---|---|
| Dietary intervention / counselingdietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks | Dietary supplement | MUFA, PUFA |
Primary outcome
change in liver fat content
Time frame: 4 and 8 weeks
change in liver fat content (MR spectroscopy and ultrasound)
change in hepatic insulin sensitivity
Time frame: 8 weeks only
change in hepatic insulin sensitivity (euglycemic hepatic clamp)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention / counseling in people with NAFLD and Obesity, run by German Institute of Human Nutrition at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 2016. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margrit Kemper, Dr. (033 200 ext. 88 2775, margrit.kemper@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in liver fat content (time frame: 4 and 8 weeks). The study lists 2 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 22 Nov 2016.