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

Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel0 sites68 target enrollmentJune 17, 2015

Overview

Phase: 未知
Intervention: Not specified
Conditions: E88.9
Sponsor: Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
Enrollment: 68
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

June 17, 2015

End Date

May 28, 2015

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel

•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;