Ignite Creation Date:
2024-05-06 @ 8:16 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02702713
Status:
TERMINATED
Last Update Posted:
2017-12-02
First Post:
2016-02-18
Brief Title:
Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing From Human Genome to Food Industry
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
Official Title:
Investigation of the Effect of Daily Consumption of Bioactive Enriched Foods BEF on Biochemical and Anthropometric Markers of Metabolic Syndrome MS
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The funding agency set a mandatory deadline for the study in order to be able to conclude the project
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATHWAY-27
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 mgdL but 400 mgdL OR
HDL-cholesterol 50 mgmL in women 40mgmL in men with fasting triglycerides 110 mgdL
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
fasting triglycerides 150 mgdL but 400 mgdL OR
HDL-cholesterol 50 mgmL in women 40mgmL in men with fasting triglycerides 110 mgdL
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None