Elevated Liver Fat Content and Insulin ResistanceresVida NAFLNCT01635114
Effect of resVida on Liver Fat Content
A study testing resveratrol in people with Elevated Liver Fat Content and Insulin Resistance, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the effects of the antioxidant "resveratrol" on liver fat content, body-composition and insulin sensitivity Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have health benefits such as improving fat metabolism, insulin action, and possibly… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Liver Fat Content and Insulin Resistance
- What is being tested?
- resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Sep 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender: male and female
- Age: 18 years - 70 years (inclusive)
- Overweight and obese (BMI ≥>27 mg/kg2)
- HOMA-IR ≥>2.0
- Negative urine pregnancy test
- Acceptable to be taking the oral contraceptive pill or other methods of birth control (surgical sterility, double barrier methods, intrauterine contraceptive device, lifestyle with a personal choice of abstinence, vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods)
- Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.
Who cannot join
- Subjects who have liver cirrhosis
- Subjects with a further liver disease diagnosis (e.g. known M. Wilson, autoimmune hepatitis, primary sclerosing cholangitis)
- Subjects who were diagnosed with diabetes
- Current pregnancy or breast feeding (as determined by a pregnancy test); postmenopausal women taking oral hormone therapy.
- Delivery within the last year
- Changes in the dose or initiation of lipid altering medication within the preceding three months, such as statins, fibrates or systemic steroids
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- Significant co-morbid inflammatory illnesses as as rheumatoid arthritis, chronic bowel disease, sarkoidosis etc.
- Contraindications to MR scanning - claustrophobia, cardiac pacemaker, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, automatic cardioverter defibrillators, prosthetic heart valves, cochlear implants, insulin pumps and nerve stimulators, etc. or who do not fit into the MR machine due to severe adiposity
- Subjects with any medical condition that is judged by the investigators to be likely to interfere with the evaluation of the subject's safety and of the study outcome.
- Subjects with abnormalities in the safety profile judged by the investigators to be clinically significant.
- Subjects with ALT or AST > 2.5x of the upper reference limit (50 U/L respectively)
- Subjects on treatment with drugs that are strongly metabolized via CYP3A4 (e.g. alfentanil, astemizole, cisapride, cyclosporine, diergotamine, ergotamine, fentanyl, irinotecan, pimozide, quinidine, sirolimus, tacrolimus, terfenadine) and CYP2C9 (e.g. Phenytoin and Warfarin)
- Smokers (> 10 cigarettes per day)
- Regular drinkers of more than15g /day (e.g wine (0,1 l), 1 beer (0,33 l)
- History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit.
- Intake of over-the-counter (OTC) medication or any dietary supplement (except occasional paracetamol/aspirin, and multivitamin supplements) for the duration of the study.
- Poor compliers or subjects unlikely to attend.
- Receipt of any investigational products (e.g., drugs, supplements, dietary interventions) as part of a research study within 30 days of initial dose administration in this study.
- Blood donation (usually 550 ml) within the 12 week period before the initial study dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Effects of resVidaTM on Liver Fat Content, Body Fat Distribution and Insulin Sensitivity
The purpose of this study is to investigate the effects of the antioxidant "resveratrol" on liver fat content, body-composition and insulin sensitivity
Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have health benefits such as improving fat metabolism, insulin action, and possibly extending lifespan. resVida™ is the name for the dietary supplement containing the natural antioxidant "resveratrol". resVida™ will be supplied by DSM Nutritional Products, Ltd.
Read more
resVida™ is considered a dietary supplement, and therefore it is not an approved drug by German Authority. It is regulated like a food. The makers of resVida™ make no claim that this supplement is meant to treat any ailment.
This study is designed to investigate the health benefits of resveratrol.
- Being tested
- resveratrol, Placebo
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrolDietary supplement
150 mg resVida per day for 12 weeks
PlaceboDietary supplement
Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| resVida (resveratrol) | Active comparator | Not described Receives: Dietary Supplement: resveratrol |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
Measured by 1H-MRS
Measured: 3 months
Secondary outcomes (5)
Body composition
Total body-, visceral- and abdominal subcutaneous fat mass and intramyocellular fat content by MR tomography and 1H-MRS
Measured: 3 months
Insulin sensitivity
Fasting serum insulin - HOMA-IR Oral Glucose Tolerance Test (OGTT) Matsuda insulin sensitivity index)
Measured: 3 months
Intima-media thickness
Of common carotid artery
Measured: 3 months
Blood analytes
Blood biochemistry
Measured: 3 months
Cardiorespiratory fitness
VO2max
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Liver Fat Content and Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Norbert Stefan, University Hospital Tuebingen
- Investigators
- Norbert Stefan, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635114
- Sponsor's protocol ID
- 2009-12-10-RESV
- Acronym
- resVida NAFL
- Status last verified
- Oct 2016
- First submitted
- 3 Jul 2012
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effects of resVidaTM on Liver Fat Content, Body Fat Distribution and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT01635114
- Acronym / sponsor ID
- resVida NAFL / 2009-12-10-RESV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Jul 2012 (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 investigate the effects of the antioxidant "resveratrol" on liver fat content, body-composition and insulin sensitivity
Resveratrol is found in grape skin, wine, peanuts, and mulberries and is thought to have health benefits such as improving fat metabolism, insulin action, and possibly extending lifespan. resVida™ is the name for the dietary supplement containing the natural antioxidant "resveratrol". resVida™ will be supplied by DSM Nutritional Products, Ltd.
resVida™ is considered a dietary supplement, and therefore it is not an approved drug by German Authority. It is regulated like a food. The makers of resVida™ make no claim that this supplement is meant to treat any ailment.
This study is designed to investigate the health benefits of resveratrol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resVida (resveratrol) | Active comparator | Dietary Supplement: resveratrol |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Gender: male and female
- Age: 18 years - 70 years (inclusive)
- Overweight and obese (BMI ≥>27 mg/kg2)
- HOMA-IR ≥>2.0
- Negative urine pregnancy test
Key exclusion criteria (19 listed)
- Subjects who have liver cirrhosis
- Subjects with a further liver disease diagnosis (e.g. known M. Wilson, autoimmune hepatitis, primary sclerosing cholangitis)
- Subjects who were diagnosed with diabetes
- Current pregnancy or breast feeding (as determined by a pregnancy test); postmenopausal women taking oral hormone therapy.
- Delivery within the last year
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 |
|---|---|---|
| resveratrol150 mg resVida per day for 12 weeks | Dietary supplement | resVida (resveratrol) |
| PlaceboPlacebo for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Liver fat content
Time frame: 3 months
Measured by 1H-MRS
5 secondary outcomes
Body composition
Time frame: 3 months
Insulin sensitivity
Time frame: 3 months
Intima-media thickness
Time frame: 3 months
Blood analytes
Time frame: 3 months
Cardiorespiratory fitness
Time frame: 3 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 25 Oct 2016.
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.
Norbert Stefan, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resveratrol in people with Elevated Liver Fat Content and Insulin Resistance, run by University Hospital Tuebingen 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 7 inclusion and 19 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 25 Oct 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?
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?
Liver fat content (time frame: 3 months). 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 25 Oct 2016.