β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
NCT ID: NCT01317264
Last Updated: 2011-03-17
Study Results
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Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2009-11-30
2011-03-31
Brief Summary
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Detailed Description
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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-glucan/d 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Placebo milk drink
no β-glucan
daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days
Millk drink with oat β-glucan
oat β-glucan
daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days
Milk drink with barley β-glucan
barley β-glucan
daily consumption of 5g β-glucan extracted from the barley-mutant mother "Bomi" in the form of milk drinks with the 3 main meals for 21 days
Milk drink with mutant-barley β-glucan
mutant-barley β-glucan
daily consumption of 5g β-glucan extracted from the high β-glucan barely mutant "lys. 5.f" in the form of milk drinks with the 3 main meals for 21 days
Interventions
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no β-glucan
daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days
oat β-glucan
daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days
barley β-glucan
daily consumption of 5g β-glucan extracted from the barley-mutant mother "Bomi" in the form of milk drinks with the 3 main meals for 21 days
mutant-barley β-glucan
daily consumption of 5g β-glucan extracted from the high β-glucan barely mutant "lys. 5.f" in the form of milk drinks with the 3 main meals for 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* elevated blood pressure
* hyperlipidemia
* consumption of dietary supplements during or 2 month prior to start of study (including vitamin tablets)
* consumption of oat and barley products from January 1st until the end of study
* smoking
* excess physical activity (\> 8h/week)
* medicine use (not included contraceptives or occasional pain killer consumption)
* pregnancy
* breast feeding
18 Years
40 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Department of Human Nutrition, University of Copenhagen
Principal Investigators
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Arne Astrup, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of human nutrition, University of Copenhagen
Locations
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University of Copenhagen
Copenhagen, , Denmark
Countries
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Other Identifiers
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M196
Identifier Type: -
Identifier Source: org_study_id
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