Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry

Summary

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.

Conditions

• Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

Dairy BEF

Dairy BEF: Milkshake powder enriched with 250 mg of DHA and 3g beta-glucans

DIETARY_SUPPLEMENT

Egg BEF

Egg BEF: Frozen pancakes enriched with 250 mg of DHA and 320 mg of anthocyanins

DIETARY_SUPPLEMENT

Bakery BEF

Bakery BEF: Biscuits enriched with 250 mg of DHA and 320 mg of anthocyanins

DIETARY_SUPPLEMENT

Bakery placebo

Bakery placebo: Biscuits without enrichment

DIETARY_SUPPLEMENT

Dairy placebo

Dairy placebo: Milkshake powder without enrichment

DIETARY_SUPPLEMENT

Egg placebo

Egg placebo: Frozen pancakes without enrichment

Sponsors & Collaborators

• Max Rubner-Institut

  collaborator UNKNOWN

• University of Leeds

  collaborator OTHER

• Centre de Recherche en Nutrition Humaine d'Auvergne

  collaborator OTHER_GOV

• University of Bologna

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  lead OTHER

Principal Investigators

• Alessandra Bordoni, MD · Department of Agro-Food Sciences and Technologies, University of Bologna

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2017-10-20

Completion

2017-10-20

Countries

• France
• Germany
• Italy
• United Kingdom

Study Locations