Trial document




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  DRKS00000383

Trial Description

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Title

Impact of milk-phospholipids compared to triacylglycerols on risk factors related to metabolic syndrome

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The metabolic syndrome is an accumulation of factors, such as abdominal obesity, increased serum lipid levels, diabetes, low HDL cholesterol level, as well as elevated blood pressure and affects one fourth of all adults worldwide. These adults have a lower life expectancy and a three times higher risk of suffering a myocardial infarction or a stroke than comparable persons. In their search for therapeutic options scientists are studying which constituents in foods can protect from these disorders and thereby provide a healthful benefit. Phospholipids possibly have such a bioactive effect. Like cholesterol and triglycerides, phospholipids belong to the group of lipids and among others are found in every cell of the body. The membrane of the milk fat globules is rich in the phospholipids sphingomyelin and phosphatidylcholine. These probably inhibit the absorption of cholesterol from the intestine into the blood. Phospholipids can also have positive effects on various blood lipids, such as HDL cholesterol, LDL cholesterol, and triglycerides. This intervention study is designed to determine if and to what extent phospholipids from milk have a positive effect on the risk parameters of the metabolic syndrome.

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Brief Summary in Scientific Language

It is assumed that the effect of phospholipids on the metabolism of animals and humans is determined by the structure of phospholipids and not primarily by their fatty acid pattern. The same fatty acids, administered either as triglycerides or as phospholipids, do not produce an identical effect. There are a number of indications that for some functions phospholipids with higher saturated fatty acids, such as the phospholipids present in the membrane of the milk fat globules, are more effective than those with polyunsaturated fatty acids. This is true for example for the inhibition of cholesterol absorption as well as for ulcer and cancer protective effects in the intestine. Furthermore, there is evidence that the individual classes of phospholipids differ in their effects. Thus phosphatidylserine is attributed special importance for the brain function and cognitive abilities. The cholin of phosphatedycholin is a donor for methyl groups and can therefore influence the synthesis of the endogenous antioxidant glutathione favourably and may lower the homocysteine level. The observed elevation of the apoA1 level and HDL cholesterol indicate additional anti-inflammatory mechanisms. Here as well the phospholipids with higher saturated fatty acids are possibly more effective. This study examines the effect of milk phospholipids on the risk factors of the metabolic syndrome (cholesterol as the primary parameter) and several indicators of inflammation and oxidative stress.

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Organizational Data

  •   DRKS00000383
  •   2010/04/13
  •   [---]*
  •   yes
  •   Approved
  •   F-2010-020, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   U1111-1114-6602 
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Health Condition or Problem studied

  •   E88.9 -  Metabolic disorder, unspecified
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Interventions/Observational Groups

  •   Daily consumption of 200 mL milk, enriched with 2 g of phospholipids, for eight weeks.
  •   Daily consumption of 200 mL milk, enriched with 2 g of triacyglycerols, for eight weeks.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Serum total- and HDL cholesterol ratio at the end of intervention (after 8 weeks)

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Secondary Outcome

Risk factors for the metabolic syndrome at the end of intervention (after 8 weeks): waist circumference, fasting blood triacylglycerol and glucose, blood pressure

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/03/24
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   50   Years
  •   75   Years
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Additional Inclusion Criteria

Male gender, overweight
Between 50 and 75 years of age
Non-smoker
Subjects who gave written consent to participate in this study

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Exclusion Criteria

Subjects with fasting glucose above 120 mg/dl
Subjects suffering from a disease regarding the resorption of nutrients, digestive function, metabolism, or excretion
Subjects with a known milk protein allergy
Subjects taking nutritional supplements during the trial period which can influence study parameters
Subjects taking medications which can influence study parameters
Subjects that underwent surgery of the gastrointestinal tract or a corticoid treatment within the past three months
Subjects with an above average consumption of milk and milk products
Subjects experiencing unjustifiable adverse events
Subjects experiencing acute gastrointestinal disease during the trial period
Subjects who do not act compliantly
Subjects who withdraw their consent to participate in the study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Max Rubner-Institut Bundesforschungsinstitut für Ernährung und Lebnsmittel
    • Haid-und-Neu-Strasse 9
    • 76131  Karlsruhe
    • Germany
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    • Forschungskreis der Ernährungsindustrie e.V. (FEI)
    • Godesberger Allee 142-148
    • 53175  Bonn
    • Germany
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    • Max Rubner-Institut Bundesforschungsinstitut für Ernährung und Lebensmittel
    • Ms.  Dr.  Maria  Pfeuffer 
    • Haid-und-Neu-Strasse 9
    • 76131  Karlsruhe
    • Germany
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    • Max Rubner-Institut Bundesforschungsinstitut für Ernährung und Lebnsmittel
    • Ms.  Anne  Weiland 
    • Haid-und-Neu-Strasse 9
    • 76131  Karlsruhe
    • Germany
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Sources of Monetary or Material Support

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    • Max Rubner-Institut Bundesforschungsinstitut für Ernährung und Lebnsmittel
    • Haid-und-Neu-Strasse 9
    • 76131  Karlsruhe
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/07/14
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Trial Publications, Results and other Documents

  •   Weiland A, Bub A, Barth SW, Schrezenmeir J, Pfeuffer M (2016) Effects of dietary milk- and soy-phospholipids on lipid-parameters and other risk indicators for 1 cardiovascular diseases in overweight or obese men: 2 -Two double blind, randomized, controlled, clinical trials- J Nutr Sci 2016:vol. 5, e21, page 1 of 9. doi:10.1017/jns.2016.9
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* This entry means the parameter is not applicable or has not been set.