Trial document





This trial has been registered retrospectively.
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  DRKS00004311

Trial Description

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Title

Biokinetic studies on the impact of formulation on resveratrol bioavailability

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Trial Acronym

Resveratrol formulation

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URL of the Trial

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Brief Summary in Lay Language

Plant polyphenols may exert health related antioxidant or vasoprotective effects. However, bioavailability in humans is limited. Therefore, new formuations should help to improve bioavailability. The aim of the present study is to investigate a formulation that should result in an improved polyphenol bioavailability. A grape-vine extract will be investigated in its original and a formulated preparation to see if absorption and metabolism are affected. Participants are males between 18 and 40 years of age. Blood and urine samples are taken to determine selected ingreedients and metabolites of grape-vine extract.

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Brief Summary in Scientific Language

In recent years the stilbene trans-resveratrol has extensively been investigated. Since resveratrol is present in grapes and grape- products, it has been linked to the French Paradox and the protection from cardiovascular disease. Additionally, anti-carcinogenic effects have been shown in various studies. Resveratrol has also been shown to interact with sirtuins, speculating that resveratrol may interact with the aging process like caloric restriction. Besides the trans-resveratrol monomer some derivatives and oligomers have been described recently, which may exert even stronger effects compared to trans-resveratrol. A grape-vine extract called Vineatrol contains trans-resveratrol as well as high amounts of such resveratrol oligomers.
Many resveratrol effects are derived from in vitro and animal studies, while studies from humans are rare. Most important for the effects of such substances is their distribution in plasma and availability in the target tissue. However, oral bioavailability of resveratrol and other phytochemicals is limited, due to low intestinal absorption and intensive metabolism by gut microbiota and endogenous phase 1 and 2 metabolism. It is questionable whether relevant concentrations of resveratrol or its metabolites in tissue can be achieved by food consumption. This may be one reason why food supplements from plant extracts are available on the market now for several years. One attempt to improve phytochemical bioavailability and function is to prepare new formulations. By this way dosage may also being reduced.
In a human intervention study bioavailability and biokinetics of resveratrol and its metabolites from a grape-vine extract is investigated. The original extract and a formulated preparation are compared in healthy volunteers in a cross-over study design. After a single dose application plasma concentrations and urinary excretion of resveratrol and its metabolites are determined within 24 hours.

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Organizational Data

  •   DRKS00004311
  •   2012/08/13
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  •   yes
  •   Approved
  •   F-2010-094, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   U1111-1133-4621 
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Health Condition or Problem studied

  •   metabolism of resveratrol in healthy volunteers
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Interventions/Observational Groups

  •   Vineatrol, 0,5 mg resveratrol-equivalents per kg body weight (single oral dose as gelatine capsule)
  •   resverasorb, 0,5 mg resveratrol-equivalents per kg body weight (single oral dose as gelatine capsule)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Active control
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

AUC, Camx, tmax of resveratrol and its metabolites in plasma. Analysis by LC-MS/MS before, 20, 40, 60, 90, 120, 180, 270, 360, 480, 720 min and 24h after intake.

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Secondary Outcome

Resveratrol and metabolite excretion in urine. Analysis by LC-MS/MS of sample periods 0-4h, 4-8h, 8-12h, and 12-24h.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2011/05/02
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

healthy men (18 - 40 Jahre)
BMI 20 – 25 kg/m2
non-smoker
participants, who gave written informed consent

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Exclusion Criteria

Subjects with serious diseases related to nutrient absorption, digestion, metabolism and excretion.
Subjects who used nutritional supplements or medication within the last three months which might interact with parameters of interest.
Subjects that might be non-compliant.
Subjects with allergies on the study substance or other ingreedients of the formulation.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Max Rubner-Institut
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
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    • Max Rubner-Institut
    • Mr.  PD Dr. med.  Achim  Bub 
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
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    • Max Rubner-Institut
    • Ms.  Oec. troph. (FH)  Anita  Kriebel 
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • Max Rubner-Institut
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/05/12
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.