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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-10-20

Brief Summary

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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:

* 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.

Detailed Description

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Conditions

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Metabolic Syndrome

Keywords

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bioactive enriched foods anthocyanins (AC) beta-glucans (BG) docosahexaenoic acid (DHA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dairy BEF + egg placebo + bakery placebo

200 subjects consuming every day for 12 weeks: 1 portion of Dairy BEF + 1 portion of Egg placebo + 1 portion of Bakery placebo

Group Type ACTIVE_COMPARATOR