Clinical trial NCT02702713: Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry
Official title: Investigation of the Effect of Daily Consumption of Bioactive Enriched Foods (BEF) on Biochemical and Anthropometric Markers of Metabolic Syndrome (MS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: bioactive
enriched foods
anthocyanins (AC)
beta-glucans (BG)
docosahexaenoic acid (DHA)
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: Max Rubner-Institut
name: University of Leeds
name: Centre de Recherche en Nutrition Humaine d'Auvergne
name: University of Bologna
First posted: 2016-03-09
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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;

Primary outcomes:
measure: Triglycerides blood levels (mg/dl)
timeFrame: Baseline and 12 weeks
measure: HDL-cholesterol blood levels (mg/dl)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Blood glucose (mg/dl).
timeFrame: Baseline and 12 weeks
measure: Blood pressure (mmHg)
timeFrame: Baseline and 12 weeks
measure: Waist circumference (cm).
timeFrame: Baseline and 12 weeks
measure: Urinary food metabolite levels (parts per millions).
timeFrame: Baseline and 12 weeks
measure: Fecal microbiota composition (analysis of principal coordinates - PCOA)
timeFrame: Baseline and 12 weeks
measure: Fecal Short Chain Fatty Acids (parts per million).
timeFrame: Baseline and 12 weeks
measure: Dna methylation levels (%).
timeFrame: Baseline and 12 weeks
measure: Serum Hemoglobin A1c (HbA1c) levels (%)
timeFrame: Baseline and 12 weeks
measure: Homeostasis Model Assessment (HOMA) Index levels.
timeFrame: Baseline and 12 weeks
measure: Fecal metabolite levels (parts per millions).
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre de Récherche en Nutrition Humaine d'Auvergne
state: Auvergne
city: Karlsruhe
country: Germany
facility: Max Rubner-Institut
state: Baden-Württemberg
city: Bologna
country: Italy
facility: University of Bologna, Department of Medical and Surgical Sciences and Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi
state: BO
city: Leeds
country: United Kingdom
facility: University of Leeds
Study officials:
affiliation: Department of Agro-Food Sciences and Technologies, University of Bologna
name: Alessandra Bordoni, MD
role: STUDY_DIRECTOR
References: