β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
|ClinicalTrials.gov Identifier: NCT01317264|
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: no β-glucan Other: oat β-glucan Other: barley β-glucan Other: mutant-barley β-glucan||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||March 2011|
|Placebo Comparator: Placebo milk drink||
Other: no β-glucan
daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days
|Experimental: Millk drink with oat β-glucan||
Other: 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
Other Name: "PromOat",Biovelop, Kimstad, Sweden
|Experimental: Milk drink with barley β-glucan||
Other: 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
|Experimental: Milk drink with mutant-barley β-glucan||
Other: 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
- change in total and LDL cholesterol concentration [ Time Frame: fasting blood sample at baseline and day 21 ]
- pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces) [ Time Frame: average over three days at baseline and after 3 weeks ]
- weight [ Time Frame: at baseline and after 1, 2 and 3 weeks ]
- food intake (in 4d records) [ Time Frame: at baseline and after 3 weeks ]
- height [ Time Frame: at baseline ]
- insulin, glucose, IL-6, CRP, TNF-α, fibrinogen, PAI-1, appetite regulation peptides, alkylresorcinol, metabolomics (in fasting and meal test blood samples) [ Time Frame: fasting blood sample at baseline and on day 21 ]
- appetite sensation (in meal tests) [ Time Frame: 3h appetite registrations at baseline and on day 21 ]
- metabolomics, isoprostanes (in 24h urine) [ Time Frame: at baseline and after 3 weeks ]
- metabolomics (in 72h feces) [ Time Frame: average over 3 days at baseline and after 3 weeks ]
- blood pressure [ Time Frame: at baseline and on day 21 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317264
|University of Copenhagen|
|Copenhagen, Denmark, 1165|
|Principal Investigator:||Arne Astrup, Professor||Department of human nutrition, University of Copenhagen|