Trial document




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  DRKS00003395

Trial Description

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Title

Impact of dietary fat intake on bioavailability and lipoprotein-associated transport of isoflavones in postmenopausal women

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Soy products contain variable amounts of isoflavones, which are widely used as nutritional supplements, especially for menopausal women as an alternative to hormonal replacement therapy. Many health effects are proposed, derived from observations in asian countries. Due to their structural similarity to endogenous estrogens, isoflavones may act like estrogens and reduce menopause symptoms, osteoporosis and cardiovascular disease. Since nearly half of isoflavones in blood are transported with lipids we aim to investigate whether dietary fat intake modulates availability of soy isoflavones in postmenopausal women.

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Brief Summary in Scientific Language

Soy-isoflavone containing nutritional supplements are often recommended to postmenopausal women as a natural alternative for hormonal replacement therapy. Many health effects are proposed derived from observations in asian countries. However, the scientific basis is poor. Isoflavone bioavailability is necessary for any biological or health effect. Availability depends on sugar-conjugation and lipoprotein association. Therefore, by means of a short term intervention (randomized, controlled, cross over) we aim to investigate the impact of dietary fat on isoflavone bioavailability. Study participants (postmenopausal women, lean, healthy, non-smoker) receive isoflavones/placebo and a controlled diet with either low or high fat for 4 weeks. At the end of each study week additional biokinetic investigations are performed.

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Organizational Data

  •   DRKS00003395
  •   2012/01/17
  •   [---]*
  •   yes
  •   Approved
  •   F-2011-006, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   U1111-1126-3904 
  •   DRKS00003493  (DRKS-ID: Studienteil2 von 2 Teilen/part 2 of 2 parts)
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Health Condition or Problem studied

  •   healthy volunteers
  •   N95.9 -  Menopausal and perimenopausal disorder, unspecified
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Interventions/Observational Groups

  •   controlled diet according to 20% energy fom fat of consumed food, as well as isoflavones following placebo
  •   controlled diet according to 40% energy fom fat of consumed food, as well as isoflavones following placebo
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Characteristics

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

Isoflavon plasma concentrations (LC-MS/MS), weekly

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Secondary Outcome

isoflavone metabolites in body fluids

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2012/01/16
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   no minimum age
  •   75   Years
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Additional Inclusion Criteria

postmenopausal women under the age of 75 years; mean BMI of 25 kg/m2; non-smoker; study participants who gave written consent

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Exclusion Criteria

hormone replacement therapy; history of breast cancer; serious health problems related to nutrient absorption, digestion, metabolism or excretion; women taking nutritional supplements or on medication during the past 3 months, which may interact with study parameters; participants who are supposed to be not complient;

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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
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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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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Max Rubner-Institut
    • Haid-und-Neu-Str. 9
    • 76131  Karlsruhe
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
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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.