Effect of resVida on Liver Fat Content

NCT01635114 | Completed DMC

• 1 other identifier: 2009-12-10-RESV
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Liver Fat Content and Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Liver fat content

  Measured by 1H-MRS

  3 months

Secondary Outcomes (5)

• Body composition

  3 months

• Insulin sensitivity

  3 months

• Intima-media thickness

  3 months

• Blood analytes

  3 months

• Cardiorespiratory fitness

  3 months

Study Arms (2)

resVida (resveratrol)

ACTIVE COMPARATOR

Dietary Supplement: resveratrol

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

resveratrol DIETARY_SUPPLEMENT

150 mg resVida per day for 12 weeks

resVida (resveratrol)

Placebo DIETARY_SUPPLEMENT

Placebo for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Norbert Stefan, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2015
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

DE (1)