Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry (PATHWAY-27)
Metabolic Syndrome
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring bioactive, enriched foods, anthocyanins (AC), beta-glucans (BG), docosahexaenoic acid (DHA)
Eligibility Criteria
Inclusion Criteria:
- subjects presenting with two to four diagnostic criteria for metabolic syndrome, at least one of them being elevated fasting triglycerides OR HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL).
Exclusion Criteria:
- subjects with five clinical criteria for metabolic syndrome
- Regular drug therapy with impact on serum lipids;
- 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;
- Diagnosis of organ failure
- Familial dyslipidemia (TG ≥ 4.5 mmol/l or 400 mg/dl);
- Illegal drug use or chronic alcoholism or smoking;
- 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 BEF;
- Women who are pregnant or lactating;
Sites / Locations
- Centre de Récherche en Nutrition Humaine d'Auvergne
- Max Rubner-Institut
- University of Bologna, Department of Medical and Surgical Sciences and Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi
- University of Leeds
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Dairy BEF + egg placebo + bakery placebo
Egg BEF + dairy placebo + bakery placebo
Bakery BEF + dairy placebo + egg placebo
All placebo
200 subjects consuming every day for 12 weeks: 1 portion of Dairy BEF + 1 portion of Egg placebo + 1 portion of Bakery placebo
200 subjects consuming every day for 12 weeks: 1 portion of Egg BEF + 1 portion of Dairy placebo + 1 portion of Bakery placebo
200 subjects consuming every day for 12 weeks: 1 portion of Bakery BEF + 1 portion of Dairy placebo + 1 portion of Egg placebo
200 subjects consuming every day for 12 weeks: 1 portion of Egg placebo + 1 portion of Dairy placebo + 1 portion of Bakery placebo