Effect of resVida on Liver Fat Content (resVida NAFL)

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.

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 Overview

• Status: Completed
• Conditions: Elevated Liver Fat Content and Insulin Resistance
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: resveratrol

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • University Hospital Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; Placebo for 12 weeks
ACTIVE_COMPARATOR: resVida (resveratrol)	Dietary supplement: resveratrol; 150 mg resVida per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver fat content	Measured by 1H-MRS	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Total body-, visceral- and abdominal subcutaneous fat mass and intramyocellular fat content by MR tomography and 1H-MRS	3 months
Insulin sensitivity	Fasting serum insulin - HOMA-IR Oral Glucose Tolerance Test (OGTT) Matsuda insulin sensitivity index)	3 months
Intima-media thickness	Of common carotid artery	3 months
Blood analytes	Blood biochemistry	3 months
Cardiorespiratory fitness	VO2max	3 months

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: DSM Nutritional Products, Inc.
• Investigators: Principal Investigator: Norbert Stefan, MD, University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (ESTIMATE): July 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: 2009-12-10-RESV