Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01317264
Enrollment
16
Registered
2011-03-17
Start date
2009-11-30
Completion date
2011-03-31
Last updated
2011-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

β-glucan, cholesterol, bile acids, blood glucose, appetite

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-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.

Interventions

OTHERno β-glucan

daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days

OTHERoat β-glucan

daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days

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

OTHERmutant-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

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* normal weight or moderately overweight (BMI 18.5-30 kg/m²)

Exclusion criteria

* chronic diseases (e.g. diabetes, cardiovascular disease) * 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

Design outcomes

Primary

MeasureTime frame
heightat baseline
change in total and LDL cholesterol concentrationfasting blood sample at baseline and day 21
pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces)average over three days at baseline and after 3 weeks
weightat baseline and after 1, 2 and 3 weeks
food intake (in 4d records)at baseline and after 3 weeks

Secondary

MeasureTime frame
blood pressureat baseline and on day 21
insulin, glucose, IL-6, CRP, TNF-α, fibrinogen, PAI-1, appetite regulation peptides, alkylresorcinol, metabolomics (in fasting and meal test blood samples)fasting blood sample at baseline and on day 21
appetite sensation (in meal tests)3h appetite registrations at baseline and on day 21
metabolomics, isoprostanes (in 24h urine)at baseline and after 3 weeks
metabolomics (in 72h feces)average over 3 days at baseline and after 3 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026