Trial document




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  DRKS00008788

Trial Description

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Title

Investigation on the bioavailability and metabolism of resveratrol an ingredient of berries in humans

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Trial Acronym

ResMet

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URL of the Trial

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Brief Summary in Lay Language

Resveratrol belongs to the so-called secondary plant compounds, which may have a positive health effect. Dietary sources of Resveratrol are e.g. berries and their products. Resveratrol was intensively investigated within the last years and gained tremendous public attention due to its potential to protect against cardiovascular disease even if consuming a fat-rich diet. Until today resveratrol was mainly investigated in animal trials.
For this reason, a human intervention study with 100 participants investigating the bioactivity and metabolisation of resveratrol, which can modulate the bioactivity, will be performed. Resveratrol is commercially available as a dietary supplement with single doses of 500 mg per oral intake. Results of own preliminary studies showed that resveratrol is metabolised by the activity of gut bacteria to different metabolites, which can be uptaken into the blood system and can be excreted in the urine. As the gut microbiota of different individuals may diversify considerably, the metabolites and their quantity can vary enormously. One aim of this study is the investigation of the variability in resveratrol metabolism among different individuals and the frequency of occurrence of specific metabolites.
For this, urine samples of all 100 participants and blood samples of a minor subgroup of 12 participants will be investigated for the bioavailability of resveratrol and its metabolites before and after intake of a capsule of resveratrol (dose 1 mg/kg body weight). Moreover, bacterial strains, which are able to metabolise resveratrol, will be isolated from human fecal samples.

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Brief Summary in Scientific Language

Trans-Resveratrol (RES) is considered to mimic effects of calorie restriction, which may prevent or reverse the detrimental effects of obesity, type 2 diabetes, hypertension, chronic inflammation and other age-associated metabolic diseases. The positive effects of resveratrol seem to be supported by immune-modulated and anti-inflammatory action.
Orally ingested RES is effectively absorbed in the gut and is metabolised by the gut microbiota and endogenous phase-II-enzymes. Our own studies confirmed the already known metabolite dihydroresveratrol and revealed the presence of two previously unknown RES metabolites: 3,4′-dihydroxy-trans-stilbene (3,4′-Di-OH-stilbene) and lunularin whereas considerable differences in the metabolite profiles between participants were observed (lunularin-producers vs. non-lunularin-producers). To confirm the former results of the metabolisation of RES and the bioavailability of intestinal bacterial metabolites a human intervention study with 100 participants will be conducted. The participants will receive a capsule with RES as a single oral dose (1 mg/kg body weight). The metabolites of RES will be investigated in urine samples (n=100) and blood samples (venous and dried capillary blood, so-called ‘dried blood spots, n=12). Lunularin- and non-lunularin-producers will be identified due to the results of the urine sample analyses. Despite the significant role of the gut microbiota in RES metabolism, little is known about the bacteria (genus and species) involved. Therefore, fecal sample of lunularin- and non-lunularin-producers will be characterised using high throughput sequencing methods and lunularin-producing bacterial strains will be isolated and identified.
Acute effects of RES on the effects of the innate immune system have not been investigated so far. Therefore blood samples of a subgroup of 12 participants will be investigated before and after 24 h intake of RES for phagocytosis, respiratory burst and acitivity of natural killer cells. The answer of cytokines of stimulated immune cells will also be measured.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008788
  •   2016/03/15
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  •   yes
  •   Approved
  •   F-2015-114, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   U1111-1179-8123 
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Health Condition or Problem studied

  •   healthy volunteers
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Interventions/Observational Groups

  •   Single oral dose of 1 mg resveratrol/kg body weight administered in a capsule
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Determination of the concentration of resveratrol (RES) and its microbial metabolites in urine (48-h- urine collection) and blood samples (of a subgroup of 12 participants) before and after (1.5, 24 and 48 hours) oral uptake of RES to identify the importance of RES microbial metabolites. Another aim of this study is the isolation and characterisation of lunularin-producing bacterial strains isolated from human fecal samples.

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Secondary Outcome

Another aim of this study is the investigation, whether a single oral uptake of RES shows acute effects on selective parameters of the immune System (phagocytosis and respiratory burst, cytokine response of ex-vivo mitogen-activated peripheral blood mononuclear cells, cytolytic activity of natural killer cells (using cytometric bead array, CBA )).
Moreover, it will be investigated if RES and its metabolites can be detected both from venous blood samples and from dried blood spots with capillary blood.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/03/29
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Healthy women and men (18-65 years old), BMI 20 – 30 kg/m2; no intake of antibiotics within the last 3 monts, no intake of laxatives or other drugs which may influence the intestinal system within the last 3 month; test persons which signed the agreement letter for the participation of this study.

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Exclusion Criteria

Intake of antibiotics within the last 3 months, intake of laxatives or other drugs which may influence the intestinal system within the last 3 month; participants with serious diseases affecting the resorption of nutrients, digestion, metabolisation or excretion, pregnancy or lactation, participants who have ingested dietary supplements or drugs within the last 3 monts which may effect the parameters investigated in this study; participants which are expected to not behave compliant, participants with known allergies against RES or intolerance of food of which RES can be extracted, participants who are institutionalized due to an administrative order or court order by a court or a governmental order, participants who did not sign the agreement letter for participation of this study

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Addresses

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    • Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
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    • Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
    • Ms.  Dr. rer. nat.  Melanie  Huch 
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
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    • Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
    • Mr.  Prof.Dr.med.  Achim  Bub 
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
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    • Max Rubner-Institut; Bundesforschungsinstitut für Ernährung und Lebensmittel
    • Ms.  Dipl.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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    • Deutsche Forschungsgemeinschaft (DFG); Team Medizin 2
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/05/23
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Trial Publications, Results and other Documents

  •   Danylec et al.; Rubneribacter badeniensis gen. nov., sp. nov. and Enteroscipio rubneri gen. nov., sp. nov., new members of the Eggerthellaceae isolated from human faeces; Int J Syst Evol Microbiol 2018;68:1533–1540
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* This entry means the parameter is not applicable or has not been set.