Trial document





This trial has been registered retrospectively.
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  DRKS00006742

Trial Description

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Title

Pilot study regarding the influence of bioactive enriched food on markers of the metabolic syndrome.

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Trial Acronym

PATHWAY-27

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URL of the Trial

http://www.pathway27.eu/

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Brief Summary in Lay Language

Many naturally-occurring substances in foods have positive health effects and are generally referred to as „bioactives“. In many cases, certain foods are enriched with these natural compounds to achieve added health benefits („functional foods“). The compounds potential positive health effects for humans are presently being analyzed, particularly with regard to preventing the metabolic syndrome. The metabolic syndrome is a combination of various risk factors, such as high blood pressure, altered blood glucose and blood lipid values (elevated triglycerides, low HDL-cholesterol levels), as well as excessive abdominal fat. These dysfunctions of the metabolic pathways can lead to cardiovascular diseases and diabetes. In this context, the present study will examine the effects of bioactive enriched milk products on the metabolic pathways in humans. The following bioactives are being used: Docosahexaenoic acid: is part of the essential fatty acids resp. omega-3-fatty acids and is predominantly found in saltwater fish. These acids have a potentially protective effect towards cardiovascular diseases. Beta-glucans: are fibers from oats and barley and can help in lowering blood cholesterol values. Anthocyanins: are water-soluble plant pigments found mostly in red-violet berries, fruits, as well as certain vegetables. They can aid in protecting our DNA.

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Brief Summary in Scientific Language

Many naturally-occurring compounds in dietary plants and animal products possess a variety of physiological functions. These natural compounds are generally known as „bioactives“. The possible effects on human health are presently being researched, particularly with regard to the prevention of food-related diseases. So far the European Food Safety Authority (EFSA) has only approved a few health claims. Therefore it is important to clarify the effectiveness of „naturally“ enriched foods (bioactive-enriched food – BEF). In this context the EU-research project „PATHWAY-27“ has assembled an interdisciplinary team in order to analyze the effects and mechanisms of action of three bioactives: docosahexaenoic acid (DHA), beta-glucans (BG), and anthocyanins (AC) in three different food groups (baked goods, milk products, and egg-based products). DHA have a potentially protective effect towards cardiovascular diseases, BG assist in lowering blood cholesterol levels, and AC are considered to have antioxidative properties. The Max Rubner-Institut participates in this project with a human intervention study of „bioactive“ enriched milk products. The aim of this pilot study is to identify the physiological relevant effects of bioactives in foods on markers of the metabolic syndrome. 100 participants will take part in a randomized, double blind, parallel dietary intervention study without a placebo. The participants are men and women at risk for metabolic syndrome. For a period of 4 weeks five groups of 20 participants each will receive a BEF enriched with DHA, BG, or AC alone or DHA + BG, or DHA + AC. Aside from anthropometric data (body weight, height, BMI, waist circumference), blood pressure, blood glucose as well as triglycerides and HDL-cholesterol will be determined.

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Organizational Data

  •   DRKS00006742
  •   2015/06/17
  •   [---]*
  •   yes
  •   Approved
  •   F-2014-062, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   U1111-1160-5125 
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Health Condition or Problem studied

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

  •   Daily consumption of a milk product enriched with docosahexaenoic (250mg) acid for a period of 4 weeks
  •   Daily consumption of a milk product enriched with beta-glucans (3g) for a period of 4 weeks
  •   Daily consumption of a milk product enriched with anthocyanins (320mg) for a period of 4 weeks
  •   Daily consumption of a milk product enriched with docosahexaenoic (250mg) acid and beta-glucans (3g) for a period of 4 weeks
  •   Daily consumption of a milk product enriched with docosahexaenoic (250mg) acid and anthocyanins (320mg) for a period of 4 weeks
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Characteristics

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

Fasting concentrations of triglycerides and HDL-cholesterol (before intervention and after 28 days) in men and women at risk for metabolic syndrome.

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Secondary Outcome

Anthropometric parameters will be recorded before intervention and after 28 days (body weight, height, BMI, waist circumference) as well as determination of blood pressure and concentrations of blood glucose). In addition biomarkers of the uptake of anthocyanins, beta-glucans, and docosahexaenoic acid will be determined.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/04/07
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

MS is defined when three of the following criteria are met:
- elevated waist circumference (men ≥ 102 cm; women ≥ 88 cm)
- elevated fasting triglycerides (≥ 150 mg/dL)
- reduced fasting HDL-cholesterol (men ≤ 40 mg/dL; women ≤ 50 mg/dL)
- elevated blood pressure (systolic ≥ 130 mmHg and/or diastolic ≥ 85 mmHg) or
hypotensive treatment
- elevated fasting glucose (≥ 110 mg/dL)
Subjects will be eligible to the pilot study if they are considered at risk of MS, i.e. if they
present two to four of the MS criteria, at least one of them being alterated of fasting
triglycerides or HDL-Cholesterol”.

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Exclusion Criteria

Participants that meet more than four of the metabolic syndrome criteria; -regular drug therapy with impact on serum lipids (e.g. statins, fibrates, ...);
- diabetes (fasting glucose ≥ 1.26 g/L, or anti-diabetic treatment);
- celiac disease, lactose intolerance, allergy to milk or egg proteins;
- antibiotic treatment within the last 3 months;
- recent history of cancer or cancer treatment (less than 2 years);
- active or recently diagnosed intestinal malabsorption;
- familial dyslipidemia;
- illegal drug use or chronic alcoholism or active smoking (≥ 5 cigarettes/day);
- intensive physical exercise (≥ 5 hour/week);
- consumption of nutritional supplements containing DHA, BG or AC;
- history of allergy or intolerance to any components used in BEFs;
institutionalised patients, those who lack autonomy to consent or are unable to meet all
examinations;
- women who are pregnant, lactating, on contraceptive treatment or hormone replacement
therapy;
- participation in other clinical trials that may impact on outcome;
- subjects deprived of their liberty by judicial or administrative decision; -Participants that are expected to be non-compliant.

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Addresses

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    • Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
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    • Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
    • Mr.  Prof.Dr.med.  Achim  Bub 
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
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    • Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
    • Ms.  Anita  Kriebel 
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
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Sources of Monetary or Material Support

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    • Max Rubner-Institut
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
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    • 7.Forschungsrahmenprogramm der EU FP7/2007-2013 unter der Fördernummer 311876
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/28
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Trial Publications, Results and other Documents

  •   Bub, A.; Malpuech-Brugère, C.; Orfila, C.; Amat, J.; Arianna, A.; Blot, A.; Di Nunzio, M.; Holmes, M.; Kertész, Z.; Marshall, L.; Nemeth, I.; Ricciardiello, L.; Seifert, S.; Sutulic, S.; Ulaszewska, M.; Bordoni, A. A Dietary Intervention of Bioactive Enriched Foods Aimed at Adults at Risk of Metabolic Syndrome: Protocol and Results from PATHWAY-27 Pilot Study. Nutrients 2019, 11, 1814.
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* This entry means the parameter is not applicable or has not been set.