Effect of resVida on Liver Fat Content (resVida NAFL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Norbert Stefan, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01635114
First received: July 3, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention
Elevated Liver Fat Content and Insulin Resistance
Dietary Supplement: resveratrol
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluate the Effects of resVidaTM on Liver Fat Content, Body Fat Distribution and Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Liver fat content [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measured by 1H-MRS


Secondary Outcome Measures:
  • Body composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Total body-, visceral- and abdominal subcutaneous fat mass and intramyocellular fat content by MR tomography and 1H-MRS

  • Insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Fasting serum insulin - HOMA-IR Oral Glucose Tolerance Test (OGTT) Matsuda insulin sensitivity index)

  • Intima-media thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Of common carotid artery

  • Blood analytes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Blood biochemistry

  • Cardiorespiratory fitness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    VO2max


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635114

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

No publications provided

Responsible Party: Norbert Stefan, Professor Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01635114     History of Changes
Other Study ID Numbers: 2009-12-10-RESV
Study First Received: July 3, 2012
Last Updated: February 19, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 28, 2014