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

Not Applicable

• Conditions: E88.9; Metabolic disorder, unspecified

• Registration Number: DRKS00006742
• Lead Sponsor: Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-05-28
• Study Start: 2015-06-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

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”.

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.