Trial document





This trial has been registered retrospectively.
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  DRKS00005076

Trial Description

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Title

Human intervention study to examine interactions between alpha-linolenic acid and quercetin

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Trial Acronym

AlaQu

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URL of the Trial

[---]*

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Brief Summary in Lay Language

ALA is abundant in certain plant foods, including various vegetable oils, such as linseed, rapeseed (canola), and soy oils, and may protect against coronary heart disease. However, the data concerning the protective role of ALA are less definitive than that for the long-chain omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). It is difficult to determine the exact impact of ALA on cardiovascular disease, because there are only a small number of well-designed intervention studies that have focused exclusively on ALA. Therefore, at present it remains unclear whether ALA has its own specific physiological effects that are independent of its being a precursor for the long-chain n-3 PUFA. ALA was shown to be converted to long-chain n-3 PUFA, but the extent to which this occurs is unclear. The conversion is supposed to be influenced by several factors including age and gender.

Quercetin is one of the most abundant phytochemical in the Western European diet. So far, the biological effects of quercetin were particularly investigated in in-vitro studies, which indicated antioxidant, anti-inflammatory, vasodilatory and enzyme-modulatory effects. In a human intervention study we found that quercetin lowered arterial blood pressure (Egert et al. British Journal of Nutrition 2009, 102(7): 1065-74).

The aim of the present project is to systematically investigate the combined effects of plant ALA and quercetin on metabolism and vascular function in healthy men and women. We hypothezise that the combined ingestion of ALA and quercetin may be more effective than the isolated intake of ALA and quercetin.

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Brief Summary in Scientific Language

ALA is abundant in certain plant foods, including various vegetable oils, such as linseed, rapeseed (canola), and soy oils, and may protect against coronary heart disease (CHD). An inverse association between ALA consumption and the incidence of CHD was found in most epidemiological studies. However, the data concerning the protective role of ALA are less definitive than that for the long-chain n-3 PUFA eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oil. It is difficult to determine the exact impact of ALA on cardiovascular disease, because there are only a small number of well-designed intervention studies that have focused exclusively on ALA. Therefore, at present it remains unclear whether ALA has its own specific physiological effects that are independent of its being a precursor for the long-chain n-3 PUFA. ALA was shown to be converted to long-chain n-3 PUFA, but the extent to which this occurs is unclear. The conversion is supposed to be influenced by several factors including age and gender.

Quercetin is one of the most abundant phytochemical in the Western European diet. So far, the biological effects of quercetin were particularly investigated in in-vitro studies, which indicated antioxidant, anti-inflammatory, vasodilatory and enzyme-modulatory effects. In a human intervention study we found that quercetin lowered arterial blood pressure (Egert et al. British Journal of Nutrition 2009, 102(7): 1065-74).

The aim of the present project is to systematically investigate the potential independent and additive effects of plant ALA and quercetin on metabolism and vascular function. To this end, we will conduct a double-blinded, placebo-controlled crossover trial in healthy men and women.

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Organizational Data

  •   DRKS00005076
  •   2013/08/01
  •   [---]*
  •   yes
  •   Approved
  •   321/12, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Healthy volunteers
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Interventions/Observational Groups

  •   alpha-Linolenic acid (3 g/d; ingestion from rapeseed oil) and placebo (from hart gelatine capsules, 0 mg quercetin); duration: 8 weeks; 8-week wash-out period between both supplementation periods
  •   alpha-Linolenic acid (3 g/d; ingestion from rapeseed oil) and quercetin (from hart gelatine capsules, 150 mg/d); duration: 8 weeks; 8-week wash-out period between both supplementation periods
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Characteristics

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

Fatty acid composition (blood); measurement at the beginning of the intervention periods (week 0), after 4 weeks (halftime) and at the end of the intervention periods (week 8)

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Secondary Outcome

systolic and diastolic blood pressure, measurement at the beginning of the intervention periods (week 0), after 4 weeks (halftime) and at the end of the intervention periods (week 8); parameters of metabolism (triglycerides, cholesterol, LDL, HDL, apolipoproteine B and A1, glucose, C-reactive protein, antioxidants, oxidized LDL) at the beginning (week 0) and end (week 8) of the intervention periods.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/05/06
  •   74
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   19   Years
  •   35   Years
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Additional Inclusion Criteria

metabolically healthy, normal body weight

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Exclusion Criteria

Metabolic diseases (e.g. diabetes mellitus), overweight, obesity

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Addresses

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    • Universität Bonn IEL Ernährungsphysiologie
    • Ms.  Dr.  Sarah  Egert 
    • Endenicher Allee 11-13
    • 53115  Bonn
    • Germany
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    • Universität Bonn IEL Ernährungsphysiologie
    • Ms.  Dr.  Sarah  Egert 
    • Endenicher Allee 11-13
    • 53115  Bonn
    • Germany
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    • Universität Bonn IEL Ernährungsphysiologie
    • Ms.  Dr.  Sarah  Egert 
    • Endenicher Allee 11-13
    • 53115  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Union zur Förderung von Öl- und Proteinpflanzen (UFOP)
    • Claire-Waldoffstr. 7
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/01
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Trial Publications, Results and other Documents

  •   Burak C, Wolffram S, Zur B, Langguth P, Fimmers R, Alteheld B, Stehle P, Egert S: Effect of alpha-linolenic acid supplementation in combination with quercetin and conversion to n-3 long-chain polyunsaturated fatty acids in humans: a randomized double-blinded placebo-controlled crossover trial. British Journal of Nutrition 2017 Mar;117(5):698-711
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* This entry means the parameter is not applicable or has not been set.