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The funding agency set a mandatory deadline for the study in order to be able to conclude the project.
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| Name | Class |
|---|---|
| Max Rubner-Institut | UNKNOWN |
| University of Leeds | OTHER |
| Centre de Recherche en Nutrition Humaine d'Auvergne | OTHER_GOV |
| University of Bologna |
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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:
Each of the four recruiting centres will recruit 200 volunteers. Participants will be randomly assigned to one of four groups to receive either:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dairy BEF + egg placebo + bakery placebo | Active Comparator | 200 subjects consuming every day for 12 weeks: 1 portion of Dairy BEF + 1 portion of Egg placebo + 1 portion of Bakery placebo |
|
| Egg BEF + dairy placebo + bakery placebo | Active Comparator | 200 subjects consuming every day for 12 weeks: 1 portion of Egg BEF + 1 portion of Dairy placebo + 1 portion of Bakery placebo |
|
| Bakery BEF + dairy placebo + egg placebo | Active Comparator | 200 subjects consuming every day for 12 weeks: 1 portion of Bakery BEF + 1 portion of Dairy placebo + 1 portion of Egg placebo |
|
| All placebo | Placebo Comparator | 200 subjects consuming every day for 12 weeks: 1 portion of Egg placebo + 1 portion of Dairy placebo + 1 portion of Bakery placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dairy BEF | Dietary Supplement | Dairy BEF: Milkshake powder enriched with 250 mg of DHA and 3g beta-glucans |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks |
| Blood pressure (mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Bordoni, MD | Department of Agro-Food Sciences and Technologies, University of Bologna | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Récherche en Nutrition Humaine d'Auvergne | Clermont-Ferrand | Auvergne | 63009 | France | ||
| Max Rubner-Institut |
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| Label | URL |
|---|---|
| Pathway-27 website | View source |
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Individual case report forms are available to collect study data into electronic form from all the recruiting centres. A central electronic database has been elaborated to capture, validate and manage the entered data by means of a variety of edit checks (e.g., subjecting the data to range checks, valid value checks, cross-checks, and manual review) that provide feedback to those entering/providing the data.
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| OTHER |
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| Egg BEF | Dietary Supplement | Egg BEF: Frozen pancakes enriched with 250 mg of DHA and 320 mg of anthocyanins |
|
| Bakery BEF | Dietary Supplement | Bakery BEF: Biscuits enriched with 250 mg of DHA and 320 mg of anthocyanins |
|
| Bakery placebo | Dietary Supplement | Bakery placebo: Biscuits without enrichment |
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| Dairy placebo | Dietary Supplement | Dairy placebo: Milkshake powder without enrichment |
|
| Egg placebo | Dietary Supplement | Egg placebo: Frozen pancakes without enrichment |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 12 weeks |
| Karlsruhe |
| Baden-Wurttemberg |
| 76131 |
| Germany |
| University of Bologna, Department of Medical and Surgical Sciences and Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi | Bologna | BO | 40138 | Italy |
| University of Leeds | Leeds | LS2 9JT | United Kingdom |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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