Metabolic SyndromePATHWAY-27NCT02702713
Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry
A study testing Dairy BEF, Egg BEF and Bakery BEF in people with Metabolic Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Dairy BEF, Egg BEF and Bakery BEF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2016to 20 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
Show all 14Show fewer
- 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;
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
France1 site
Centre de Récherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, Auvergne, 63009
Italy1 site
University of Bologna, Department of Medical and Surgical Sciences and Azienda Ospedaliero Universitaria di Bologna, Policlinico S.Orsola-Malpighi
Bologna, BO, 40138
About this study
Official title: Investigation of the Effect of Daily Consumption of Bioactive Enriched Foods (BEF) on Biochemical and Anthropometric Markers of Metabolic Syndrome (MS)
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).
Read more
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
- Being tested
- Dairy BEF, Egg BEF, Bakery BEF, Bakery placebo, Dairy placebo
- Keywords
- bioactive, enriched foods, anthocyanins (AC), beta-glucans (BG), docosahexaenoic acid (DHA)
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy BEFDietary supplement
Dairy BEF: Milkshake powder enriched with 250 mg of DHA and 3g beta-glucans
Egg BEFDietary supplement
Egg BEF: Frozen pancakes enriched with 250 mg of DHA and 320 mg of anthocyanins
Bakery BEFDietary supplement
Bakery BEF: Biscuits enriched with 250 mg of DHA and 320 mg of anthocyanins
Bakery placeboDietary supplement
Bakery placebo: Biscuits without enrichment
Dairy placeboDietary supplement
Dairy placebo: Milkshake powder without enrichment
Egg placeboDietary supplement
Egg placebo: Frozen pancakes without enrichment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Dairy BEF; Dietary Supplement: Bakery placebo; Dietary 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 Receives: Dietary Supplement: Egg BEF; Dietary Supplement: Bakery placebo; Dietary 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 Receives: Dietary Supplement: Bakery BEF; Dietary Supplement: Dairy placebo; Dietary 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 Receives: Dietary Supplement: Bakery placebo; Dietary Supplement: Dairy placebo; Dietary Supplement: Egg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and 12 weeks
Secondary outcomes (10)
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.
Measured: Baseline and 12 weeks
Blood pressure (mmHg)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Why it stopped: The funding agency set a mandatory deadline for the study in order to be able to conclude the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Max Rubner-Institut, University of Leeds, Centre de Recherche en Nutrition Humaine d'Auvergne, University of Bologna
- Responsible party
- Principal investigator, Luigi Ricciardiello, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Alessandra Bordoni, MD, Study director, Department of Agro-Food Sciences and Technologies, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702713
- Sponsor's protocol ID
- 147/2015/U/Sper
- Acronym
- PATHWAY-27
- Status last verified
- Nov 2017
- First submitted
- 18 Feb 2016
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Daily Consumption of Bioactive Enriched Foods (BEF) on Biochemical and Anthropometric Markers of Metabolic Syndrome (MS)
- ClinicalTrials.gov ID
- NCT02702713
- Acronym / sponsor ID
- PATHWAY-27 / 147/2015/U/Sper
- Conditions
- Metabolic Syndrome
- Keywords
- bioactive, enriched foods, anthocyanins (AC), beta-glucans (BG), docosahexaenoic acid (DHA)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding agency set a mandatory deadline for the study in order to be able to conclude the project.
- Enrolment
- 325 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Max Rubner-Institut, University of Leeds, Centre de Recherche en Nutrition Humaine d'Auvergne, University of Bologna
- Study start
- Feb 2016
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dairy BEF + egg placebo + bakery placebo | Active comparator | Dietary Supplement: Dairy BEF, Dietary Supplement: Bakery placebo, Dietary Supplement: Egg placebo200 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 | Dietary Supplement: Egg BEF, Dietary Supplement: Bakery placebo, Dietary Supplement: Dairy placebo200 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 | Dietary Supplement: Bakery BEF, Dietary Supplement: Dairy placebo, Dietary Supplement: Egg placebo200 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 | Dietary Supplement: Bakery placebo, Dietary Supplement: Dairy placebo, Dietary Supplement: Egg placebo200 subjects consuming every day for 12 weeks: 1 portion of Egg placebo + 1 portion of Dairy placebo + 1 portion of Bakery placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy BEFDairy BEF: Milkshake powder enriched with 250 mg of DHA and 3g beta-glucans | Dietary supplement | Dairy BEF + egg placebo + bakery placebo |
| Egg BEFEgg BEF: Frozen pancakes enriched with 250 mg of DHA and 320 mg of anthocyanins | Dietary supplement | Egg BEF + dairy placebo + bakery placebo |
| Bakery BEFBakery BEF: Biscuits enriched with 250 mg of DHA and 320 mg of anthocyanins | Dietary supplement | Bakery BEF + dairy placebo + egg placebo |
| Bakery placeboBakery placebo: Biscuits without enrichment | Dietary supplement | All placebo, Dairy BEF + egg placebo + bakery placebo, Egg BEF + dairy placebo + bakery placebo |
| Dairy placeboDairy placebo: Milkshake powder without enrichment | Dietary supplement | All placebo, Bakery BEF + dairy placebo + egg placebo, Egg BEF + dairy placebo + bakery placebo |
| Egg placeboEgg placebo: Frozen pancakes without enrichment | Dietary supplement | All placebo, Bakery BEF + dairy placebo + egg placebo, Dairy BEF + egg placebo + bakery placebo |
Primary outcome
Triglycerides blood levels (mg/dl)
Time frame: Baseline and 12 weeks
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.
HDL-cholesterol blood levels (mg/dl)
Time frame: Baseline and 12 weeks
Change from baseline in HDL-cholesterol blood levels after 12 weeks of consumption of foods
10 secondary outcomes
Blood glucose (mg/dl).
Time frame: Baseline and 12 weeks
Blood pressure (mmHg)
Time frame: Baseline and 12 weeks
Waist circumference (cm).
Time frame: Baseline and 12 weeks
Urinary food metabolite levels (parts per millions).
Time frame: Baseline and 12 weeks
Fecal microbiota composition (analysis of principal coordinates - PCOA)
Time frame: Baseline and 12 weeks
Fecal Short Chain Fatty Acids (parts per million).
Time frame: Baseline and 12 weeks
Dna methylation levels (%).
Time frame: Baseline and 12 weeks
Serum Hemoglobin A1c (HbA1c) levels (%)
Time frame: Baseline and 12 weeks
Homeostasis Model Assessment (HOMA) Index levels.
Time frame: Baseline and 12 weeks
Fecal metabolite levels (parts per millions).
Time frame: Baseline and 12 weeks
Results and safety
The study was stopped early (reason given: The funding agency set a mandatory deadline for the study in order to be able to conclude the project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Pathway-27 websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Bordoni, MD study director
Department of Agro-Food Sciences and Technologies, University of Bologna
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy BEF, Egg BEF and Bakery BEF in people with Metabolic Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The funding agency set a mandatory deadline for the study in order to be able to conclude the project.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglycerides blood levels (mg/dl) (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.