NCT01317264

β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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-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

• Healthy

Interventions

Type	Name	Description
OTHER	no β-glucan	daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days
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	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
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

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2011-03-17
• Last updated: 2011-03-17

Locations

1 site across 1 country: Denmark