NCT02702713

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
4 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

February 18, 2016

Last Update Submit

November 29, 2017

Conditions

Metabolic Syndrome

Keywords

bioactiveenriched foodsanthocyanins (AC)beta-glucans (BG)docosahexaenoic acid (DHA)

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (10)

  • Blood glucose (mg/dl).

    Baseline and 12 weeks

  • Blood pressure (mmHg)

    Baseline and 12 weeks

  • Waist circumference (cm).

    Baseline and 12 weeks

  • Urinary food metabolite levels (parts per millions).

    Baseline and 12 weeks

  • Fecal microbiota composition (analysis of principal coordinates - PCOA)

    Baseline and 12 weeks

  • +5 more secondary outcomes

Study Arms (4)

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

Dietary Supplement: Dairy BEFDietary Supplement: Bakery placeboDietary Supplement: Egg 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

Dietary Supplement: Egg BEFDietary Supplement: Bakery placeboDietary Supplement: Dairy 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

Dietary Supplement: Bakery BEFDietary Supplement: Dairy placeboDietary Supplement: 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

Dietary Supplement: Bakery placeboDietary Supplement: Dairy placeboDietary Supplement: Egg placebo

Interventions

Dairy BEFDIETARY_SUPPLEMENT

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

Dairy BEF + egg placebo + bakery placebo
Egg BEFDIETARY_SUPPLEMENT

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

Egg BEF + dairy placebo + bakery placebo
Bakery BEFDIETARY_SUPPLEMENT

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

Bakery BEF + dairy placebo + egg placebo
Bakery placeboDIETARY_SUPPLEMENT

Bakery placebo: Biscuits without enrichment

All placeboDairy BEF + egg placebo + bakery placeboEgg BEF + dairy placebo + bakery placebo
Dairy placeboDIETARY_SUPPLEMENT

Dairy placebo: Milkshake powder without enrichment

All placeboBakery BEF + dairy placebo + egg placeboEgg BEF + dairy placebo + bakery placebo
Egg placeboDIETARY_SUPPLEMENT

Egg placebo: Frozen pancakes without enrichment

All placeboBakery BEF + dairy placebo + egg placeboDairy BEF + egg placebo + bakery placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre de Récherche en Nutrition Humaine d'Auvergne

Clermont-Ferrand, Auvergne, 63009, France

Location

Max Rubner-Institut

Karlsruhe, Baden-Wurttemberg, 76131, Germany

Location

University of Bologna, Department of Medical and Surgical Sciences and Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi

Bologna, BO, 40138, Italy

Location

University of Leeds

Leeds, LS2 9JT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Alessandra Bordoni, MD

    Department of Agro-Food Sciences and Technologies, University of Bologna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Gastroenterology, University of Bologna

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 9, 2016

Study Start

February 1, 2016

Primary Completion

October 20, 2017

Study Completion

October 20, 2017

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

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.

Locations

GB(1)DE(1)FR(1)IT(1)