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Pilot study regarding the influence of bioactive enriched food on markers of the metabolic syndrome. - PATHWAY-27

Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel0 个研究点目标入组 68 人开始时间: 2015年6月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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”.

•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
•- 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.

发起方

Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel