Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003125

Trial Description

start of 1:1-Block title

Title

Influence of milk as compared to soy phospholipids on risk factors for cardiovascular disease

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

Trial Acronym

[---]*

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

Phospholipids are a class of lipids like cholesterol and triglycerides. They are found in all cells of the body as well as in foods. Phospholipids of milk are rich in phosphatidylcholine and sphingomyelin. Soy phospholipids (phospholipids of plant origin) have a different phospholipid pattern than milk phospholipids. Furthermore their fatty acid pattern is different. They contain primarily polyunsaturated fatty acids, while milk phospholipids are rich in saturated fatty acids.
In this intervention study two groups of overweight or obese men aged 50 to 76 years consume daily 250 ml milk which contains in addition either 3g milk phospholipids or 3g soy phospholipids. At the start and after 7 weeks fasting blood samples are collected and body composition is determined. In blood or plasma various parameters are determined which affect the risk for cardiovascular disease, like total, HDL and LDL cholesterol, triglycerides and glucose.
Phospholipids in the diet can inhibit the absorption of cholesterol from the intestine into the blood stream. By this way and through other mechanisms they can modify cholesterol metabolism, as well as hepatic metabolism and inflammatory and antioxidative functions in the body in a favourable way. It is assumed that the fatty acid pattern of phospholipids is only of secondary importance, and that milk phospholipids have a comparable or even better effect on these risk parameters than soy phospholipids.

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

Brief Summary in Scientific Language

It is assumed that the effect of phospholipids on human and animal metabolism is primarily determined by the phospholipid structure and only secondarily by their fatty acid pattern. Fatty acids given as either triglycerides or phospholipids exert different effects. Phospholipids of the milk fat globule contain more saturated fatty acids than plant phospholipids. These more saturated phospholipids seem to have specific metabolic roles, different from those with more unsaturated fatty acids. Furthermore different phospholipid classes play different metabolic roles. Choline in phosphatidylcholine is a source of methyl groups, and may thus modulate the synthesis of the endogenous antioxidans glutathione and lower the homocysteine concentration in plasma. Furthermore phospholipids can increase the concentration of apolipoprotein A1 and HDL-cholesterol, additional antiinflammatory mechanisms. In this respect phospholipids with more saturated fatty acids may be more effective. The present study examines the effect of milk phospholipids as compared to soy phospholipids on risk factors for cardiovascular disease (the ratio of total-to-HDL-cholesterol as primary parameter) and various parameters of hepatic metabolism, inflammation and oxidative stress.

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

Organizational Data

  •   DRKS00003125
  •   2011/06/09
  •   [---]*
  •   yes
  •   Approved
  •   F-2010-089, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E78.9 -  Disorder of lipoprotein metabolism, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Daily consumption of 250 mL milk, enriched with 3 g milk phospholipids, during 7 weeks
  •   Daily consumption of 250 mL milk, enriched with 3 g soy phospholipids, during 7 weeks
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   [---]*
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Ratio of total zu HDL-cholesterol in serum (after 7 weeks)

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

Secondary Outcome

Further parameters of lipid metabolism(triglycerides, LDL-cholesterol), glucose metabolism (glucose, insulin), hepatic metabolism (GOT, GGT, GPT), thiol metabolism (glutathione, homocysteine), inflammation (CRP, endothelial adhesion molecules) and body composition after 7 weeks 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

  •   Actual
  •   2011/01/26
  •   62
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   50   Years
  •   76   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Overweight male volunteers, age 50- 76 years, non-smokers; written informed consent

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

Exclusion Criteria

- fasting glucose levels >120 mg/dl
- Known metabolic or gastro-intestinal diseases, which affect the absorption, metabolism or excretion of food or food components;
- Known allergy against milk or soy components
- intake of supplements which might affect the parameters tested
- intake of drugs which might affect the parameters tested
- intestinal tract surgery or corticoid steroid treatment within the last 3 months
- Inability to understand and to comply with the study protocol;
- unusually high consumption of milk or dairy products
- occurrence of acute gastrointestinal disorders during intervention
- Occurrence of other unexpected events with relevance for the study outcome
- withdrawal of consent to participate

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 Bundesforschungsinstitut für Ernährung und Lebensmittel
    • Haid-und-Neu-Strasse 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 Bundesforschungsinstitut für Ernährung und Lebensmittel
    • Ms.  Dr.  Maria  Pfeuffer 
    • Haid-und-Neu-Strasse 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 Bundesforschungsinstitut für Ernährung und Lebnsmittel
    • Ms.  MSc  Anne  Weiland 
    • Haid-und-Neu-Strasse 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
    • Max Rubner-Institut Bundesforschungsinstitut für Ernährung und Lebensmittel
    • Haid-und-Neu-Strasse 9
    • 76131  Karlsruhe
    • 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
    • Forschungskreis der Ernährungsindustrie e.V. (FEI)
    • Godesberger Allee 142-148
    • 53175   Bonn
    • 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 complete, follow-up complete
  •   2011/06/09
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Weiland A, Bub A, Barth SW, Schrezenmeir J, Pfeuffer M. Effects of dietary milk- and soy-phospholipids on lipid-parameters and other risk indicators for cardiovascular diseases in overweight or obese men - Two double blind, randomized, controlled, clinical trials. J Nutr Sci 2016; vol. 5, e21, page 1-9. (doi:10.1017/jns.2016.9)
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.