This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be recruited. Subjects will be eligible to the study if they present with two to four of the MS diagnostic criteria, at least one of them being: * fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR * HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL). Each of the four recruiting centres will recruit 200 volunteers. Participants will be randomly assigned to one of four groups to receive either: * Dairy BEF + egg placebo + bakery placebo * Egg BEF + dairy placebo + bakery placebo * Bakery BEF + dairy placebo + egg placebo * Dairy, egg and bakery placebo Participants will be required to consume all three of the allocated products each day for 12 weeks. Eligible volunteers will be included and randomly allocated to one of the four groups. At baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will complete questionnaires relating to their satisfaction with the food products, compliance to consumption of the study food products, and any gastrointestinal side effects or health-related adverse events that have occurred in the previous 3 weeks. At each recruiting centre 40 participants will be required to take part in additional activities, these are: stool sample collection, adipose tissue aspiration, body composition analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
325
Dairy BEF: Milkshake powder enriched with 250 mg of DHA and 3g beta-glucans
Egg BEF: Frozen pancakes enriched with 250 mg of DHA and 320 mg of anthocyanins
Bakery BEF: Biscuits enriched with 250 mg of DHA and 320 mg of anthocyanins
Bakery placebo: Biscuits without enrichment
Dairy placebo: Milkshake powder without enrichment
Egg placebo: Frozen pancakes without enrichment
Centre de Récherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, Auvergne, France
Max Rubner-Institut
Karlsruhe, Baden-Wurttemberg, Germany
University of Bologna, Department of Medical and Surgical Sciences and Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi
Bologna, BO, Italy
University of Leeds
Leeds, United Kingdom
Triglycerides blood levels (mg/dl)
Change from baseline in triglycerides blood levels after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
HDL-cholesterol blood levels (mg/dl)
Change from baseline in HDL-cholesterol blood levels after 12 weeks of consumption of foods
Time frame: Baseline and 12 weeks
Blood glucose (mg/dl).
Change from baseline in blood glucose levels after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
Blood pressure (mmHg)
Change from baseline in blood pressure after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
Waist circumference (cm).
Change from baseline in waist circumference after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
Urinary food metabolite levels (parts per millions).
Changes from baseline in urinary food metabolite levels, after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
Fecal microbiota composition (analysis of principal coordinates - PCOA)
Changes in fecal bacterial composition and diversity will be determined at baseline and after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS. The predominant microbial community and specific functional groups will be characterized by next-generation sequencing (NGS) of the 16S rDNA gene. The interindividual differences in the composition of the intestinal microbiota (beta-diversity) will be evaluated with the analysis of principal coordinates (PCOA). Appropriate statistical analysis will be performed to evaluate significant differences in the relative abundance of the microbial groups of intestinal microbiota between different groups of subjects.
Time frame: Baseline and 12 weeks
Fecal Short Chain Fatty Acids (parts per million).
Change from baseline in production/uptake in the stool of Short Chain Fatty Acids, after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
Dna methylation levels (%).
To test whether lymphocytes may be useful as a surrogate for adipose tissue to detect changes in DNA methylation and gene expression, genome-wide methylation differences will be performed in parallel in lymphocytes and fat cells from baseline and after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS. Expression of affected genes will be evaluated by qRT-PCR.
Time frame: Baseline and 12 weeks
Serum Hemoglobin A1c (HbA1c) levels (%)
Change from baseline in HbA1c levels, after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
Homeostasis Model Assessment (HOMA) Index levels.
Change from baseline in Homeostasis Model Assessment Index levels, after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
Fecal metabolite levels (parts per millions).
Change from baseline in food metabolite levels in the stools after 12 weeks of consumption of foods enriched with DHA, alone or in combination with AC or BG, in subjects at risk for or affected by MS.
Time frame: Baseline and 12 weeks
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