Trial document




drksid header

  DRKS00000708

Trial Description

start of 1:1-Block title

Title

Impact of total body fat on bioavailability and biofunctionality of isoflavones in postmenopausal women

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Body fat and isoflavone biofunctionality

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In asian countries with traditionally high consumption of soy food breast cancer risk is lower compared to western countries. Bioactive substances from soy, called isoflavones, may contribute to this observation. These isoflavones are associated to lipoproteins, the fat transport molecules in blood. However, so far the role of total body fat on isoflavone availability and distribution in humans is unclear. Therefore, this study aims to investigate the impact of total body fat on availability and function of soy isoflavones in women.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Dietary suppements containing high amounts of soy isoflavones are promoted and used as alternatives for hormone replacement therapy addressing postmenopausal women as a target group. Based on observation from asian countries health promoting actions of these compounds are postulated, e.g. a cancer preventing action for hormone-dependend tumors like breast cancer. Isoflavones and estrogens show quite similar chemical structures, that might be the basis for isoflavone actions. The transport of endogenous estrogens and their role in fat metabolism are well investigated in humans. This is also the case for obesity and estrogens as breast cancer risk factors. The knowledge about the role of isoflavones in this context is poor. In our own studies we could show that isoflavones are transported in blood highly associated to lipoproteins. Whether or not estrogen related functions on lipoproteins are modulated by isoflavones has not been investigated so far. Considering obesity as a cancer risk factor and obesity associated lipid disorders it is of high scientific interest whether endogenous estrogens and dietary isoflavones do interact. The role of total body fat on isoflavone availability and function in humans and the possible interaction with endogenous estrogens has not been investigated before. Therefore, this study aims to investigate the impact of total body fat on availability and function of soy isoflavones in women. During a human dietary intervention study postmenopausal women will receive an isoflavone supplement or placebo for 12 weeks. To investigate the impact of total body fat on isoflavone availability and function body composition will be analysed by DEXA (Dual-Energy X-ray Absorptiometry). Isoflavones, their metabolites, adipokines and sex hormones in blood will be determined as well as the expression pattern of lipid metabolism related proteins and the methylation pattern in peripheral blood lymphocytes.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000708
  •   2011/02/10
  •   [---]*
  •   yes
  •   Approved
  •   F-2011-004, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1119-3854 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E66.09 -  [generalization E66.0: Obesity due to excess calories]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   isoflavone extract from soy (Novasoy®), 1 capsule á 100mg orally per day for 12 weeks
  •   placebo
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

isoflavones plasma concentrations, before and 4, 8, and 12 weeks after Intervention, LC-MS/MS analysis

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

isoflavones and metabolites in lipoproteins (ultracentrifugation, LC-MS/MS), adipokines (ELISA) und sex hormones (HPLC) in serum, protein expression (flow cytometry, western blotting) und methylation pattern in peripheral lymphocytes (MASS-Array); before and after 12 weeks of intervention.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2012/01/02
  •   400
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   no minimum age
  •   74   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

postmenopausal women aged below 75y, BMI 20-25 and above 30 kg/m2, non-smoker who gave written consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

hormone replacement therapy, breast cancer, serious diseases related to resorption, digestion, metabolism or excretion, use of supplements or medication withon the last 3 months that could have an impact on major parameter, non-compliant volunteers

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Max Rubner-Institut
    • Mr.  PD Dr. med.  Achim  Bub 
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Max Rubner-Institut
    • Mr.  PD Dr. med.  Achim  Bub 
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Max Rubner-Institut
    • Ms.  Oec. troph. (FH)  Anita  Kriebel 
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft DFG
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Max Rubner-Institut
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.