Effect of resVida on Liver Fat Content (resVida NAFL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01635114
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : October 25, 2016
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Norbert Stefan, University Hospital Tuebingen

Brief 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 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.

Condition or disease Intervention/treatment Phase
Elevated Liver Fat Content and Insulin Resistance Dietary Supplement: resveratrol Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluate the Effects of resVidaTM on Liver Fat Content, Body Fat Distribution and Insulin Sensitivity
Study Start Date : June 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: resVida (resveratrol) Dietary Supplement: resveratrol
150 mg resVida per day for 12 weeks
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo for 12 weeks

Primary Outcome Measures :
  1. Liver fat content [ Time Frame: 3 months ]
    Measured by 1H-MRS

Secondary Outcome Measures :
  1. Body composition [ Time Frame: 3 months ]
    Total body-, visceral- and abdominal subcutaneous fat mass and intramyocellular fat content by MR tomography and 1H-MRS

  2. Insulin sensitivity [ Time Frame: 3 months ]
    Fasting serum insulin - HOMA-IR Oral Glucose Tolerance Test (OGTT) Matsuda insulin sensitivity index)

  3. Intima-media thickness [ Time Frame: 3 months ]
    Of common carotid artery

  4. Blood analytes [ Time Frame: 3 months ]
    Blood biochemistry

  5. Cardiorespiratory fitness [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01635114

University Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
DSM Nutritional Products, Inc.
Principal Investigator: Norbert Stefan, MD University Hospital Tuebingen

Responsible Party: Norbert Stefan, Professor Dr. med., University Hospital Tuebingen Identifier: NCT01635114     History of Changes
Other Study ID Numbers: 2009-12-10-RESV
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents