Ignite Creation Date:
2024-05-05 @ 11:21 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01317264
Status:
COMPLETED
Last Update Posted:
2011-03-17
First Post:
2011-03-11
Brief Title:
β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the potential disease preventive effects of β-glucans from oat and barley
Detailed Description:
Objective
The primary aim is to examine whether consumption of oat and two different barley β-glucans exhibits hypocholesterolemic effects and to understand the underlying mechanisms
Secondary aims are to investigate whether there are also effects on blood pressure appetite regulation insulin sensitivity hemostasis low-grade inflammation and the metabolic profile of different biological materials
Intervention
In each of the 4 intervention periods the participants drink a milk drink together with their three main meals for 21 days This way they consume 5g β-glucand form either oat or barley in the three treatment periods otherwise they maintain their habitual diet They are not however allowed to eat any oat- or barley-containing products during the trial
At the beginning and at the end of each intervention period the participants blood pressure is measured and a fasting blood sample is drawn
Further they collect feces for 72 hours and urine for 24 hours before and at the end of each intervention period
Before and at the end of each intervention period a 4-hour meal test is undertaken to measure their subject appetite sensation Here at first a fasting blood samples drawn and thereafter the milk drink is served Appetite sensation is assessed every 30 min for 4 hours Also blood samples are drawn at 2 hours and 4 hours at the meal tests which takes place before each intervention period
At the subsequent ad libitum lunch meal the food intake is measured and then a final appetite registration is made
Furthermore participants make 4-d food records before and at the end of each intervention period
The primary aim is to examine whether consumption of oat and two different barley β-glucans exhibits hypocholesterolemic effects and to understand the underlying mechanisms
Secondary aims are to investigate whether there are also effects on blood pressure appetite regulation insulin sensitivity hemostasis low-grade inflammation and the metabolic profile of different biological materials
Intervention
In each of the 4 intervention periods the participants drink a milk drink together with their three main meals for 21 days This way they consume 5g β-glucand form either oat or barley in the three treatment periods otherwise they maintain their habitual diet They are not however allowed to eat any oat- or barley-containing products during the trial
At the beginning and at the end of each intervention period the participants blood pressure is measured and a fasting blood sample is drawn
Further they collect feces for 72 hours and urine for 24 hours before and at the end of each intervention period
Before and at the end of each intervention period a 4-hour meal test is undertaken to measure their subject appetite sensation Here at first a fasting blood samples drawn and thereafter the milk drink is served Appetite sensation is assessed every 30 min for 4 hours Also blood samples are drawn at 2 hours and 4 hours at the meal tests which takes place before each intervention period
At the subsequent ad libitum lunch meal the food intake is measured and then a final appetite registration is made
Furthermore participants make 4-d food records before and at the end of each intervention period
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