Trial document




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  DRKS00000589

Trial Description

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Title

Effect of a dietary supplement with tocotrienols and polymethoxylated flavones (PMF) on serum lipid parameters in probands with hypercholesterolemia and elevated hsCRP levels

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Influence of a nutritive supplement on hyperlipidemia, specifically LDL-hypercholesterolemia, and elevated inflammatory markers (e.g. high sensitive C-reactive protein). The investigation will be performed in a placebo-controlled double-blind study with three arms. The study sample will include approximately 120 probands with hypercholesterolemia and elevated hsCRP levels, which are not pre-treated with lipid-lowering medications. Probands will be screened for inclusion and exclusion criteria. Additionally, potential probands will be invited for a blood test. Only probands that fulfill inclusion criteria on LDL-Cholesterol (≥ 130 mg/dL) and hsCRP (≥ 2 mg/L) levels will be included in the study sample. Screening will be at week -2 and intervention time at week 0, week 6 and week 12.
Hypothesis: Decrease of blood lipids (especially LDL-cholesterol) and of inflammatory markers by a nutritive supplement with tocotrienols and flavones compared to placebo.

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Brief Summary in Scientific Language

The aim of the study is the examination of the efficacy and safety of a dietary supplement with tocotrienols and PMFs and a similar emulsified formulation in probands with hypercholesterolemia and elevated hsCRP levels compared to placebo. Moreover, differences in bioavailability and efficacy between the two verum preparations will be investigated.
The course of several serum lipid and inflammatory parameters will be monitored over the study duration of 12 weeks. Moreover, the tolerance of the dietary supplements will be monitored by documenting adverse events and measuring blood glucose levels during the observation period.

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Organizational Data

  •   DRKS00000589
  •   2010/10/20
  •   [---]*
  •   no
  •   Approved
  •   010/2106, Freiburger Ethik-Kommission International
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Secondary IDs

  •   U1111-1117-4527 
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Health Condition or Problem studied

  •   E78 -  Disorders of lipoprotein metabolism and other lipidaemias
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   verum 1: dietary supplement with tocotrienols (4.5 mg per capsule) and polymethoxylated flavones (PMF; 40.5 mg per capsule). One capsule twice a day together with food, un-chewed.
  •   verum 2: dietary supplement with tocotrienols (8.3 mg per capsules) and polymethoxylated flavones (PMF; 16.3 mg per capsules). One capsule twice a day together with food, un-chewed.
  •   placebo. One capsule twice a day together with food, un-chewed.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Other
  •   Parallel
  •   N/A
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Primary Outcome

LDL-Cholesterol, fasting blood sample every examination (week -2, week 0, week 6, week 12)

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Secondary Outcome

Lipid parameters (TC, TG, HDL), Inflammation parameters (hsCRP, TNF-a), Liver enzymes: AST, ALT, γGT, Blood glucose, Blood picture, Anthropometric data (height, weight, BMI)
Blood pressure and pulse, Family anamnesis. Fasting blood sample and questionnaires every examination (week -2, week 0, week 6, week 12).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/11/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Caucasians, LDL-C ≥ 130 mg/dL (≥ 3.3 mmol/L) and, persisting hsCRP ≥ 2 mg/L, written confirmation of participants after detailed oral and written explanation about the study contents, and - requirements, ability and willingness of the participants to attend the investigator's orders (compliance of the study conditions, consumption of the dietary study supplements according to the dosage recommendation)

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Exclusion Criteria

Triglyceride ≥ 400 mg/dL (≥ 4,5 mmol/L).
Total Cholesterol ≥ 500 mg/dL (≥ 13 mmol/L).
hsCRP ≥ 10 mg/L.
Body-Mass-Index (BMI) ≥ 35.
Simultaneous treatment with lipid lowering medication (e. g. Fibrates, bile acid exchanger resin, phytosteroles, Ezetimibe).
treatment with HMG-CoA-reductase inhibitors (statins) in the last three month.
Simultaneous consumption of coagulation-inhibiting drugs (for example Marcumar)
routine consumption of laxative.
taking any supplements with omega-3 fatty acids, Vitamine E, phytosteroles, polyglucosamines (Chitosan) or other lipid binding ingredients.
heavy chronic diseases (tumors, diabetes typ 1, etc.), documented coronary heart disease, blood clotting disorders, renal failure, liver diseases.
chronic inflammatory diseases (e. g. Colitis ulcerosa, Morbus Crohn, rheumatoid arthritis).
allergy or intolerance to any ingredients of the test products.
common exclusion criterias like
o pregnancy and lactation
o alcohol-, drug- and/or medicament dependence
o subjects who are not in agreement with the study conditions
o refusial or rather reset of the consent from the subject
o active participation in other clinical trial within the last 30 days

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Addresses

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    • Leibniz Universtiät Hannover Institut für Lebensmittelwissenschaft und Humanernährung
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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    • Leibniz Universtät Hannover Institut für Lebensmittelwissenschaft und Humanernährung
    • Mr.  Dr.  Jan Philipp  Schuchardt 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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    • Leibniz Universtät Hannover Institut für Lebensmittelwissenschaft und Humanernährung
    • Ms.  M.Sc.  Stefanie  Plötz 
    • Am Kleinen Felde 30
    • 30167  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Dr. Loges + Co GmbH
    • Schützenstr. 5
    • 21423   Winsen (Luhe)
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/07/28
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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.