- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01317264
β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 1165
- University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo milk drink
|
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
|
daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days
Other Names:
|
Experimental: Milk drink with 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in total and LDL cholesterol concentration
Time Frame: fasting blood sample at baseline and day 21
|
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
|
average over three days at baseline and after 3 weeks
|
weight
Time Frame: at baseline and after 1, 2 and 3 weeks
|
at baseline and after 1, 2 and 3 weeks
|
food intake (in 4d records)
Time Frame: at baseline and after 3 weeks
|
at baseline and after 3 weeks
|
height
Time Frame: at baseline
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
3h appetite registrations at baseline and on day 21
|
metabolomics, isoprostanes (in 24h urine)
Time Frame: at baseline and after 3 weeks
|
at baseline and after 3 weeks
|
metabolomics (in 72h feces)
Time Frame: average over 3 days at baseline and after 3 weeks
|
average over 3 days at baseline and after 3 weeks
|
blood pressure
Time Frame: at baseline and on day 21
|
at baseline and on day 21
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arne Astrup, Professor, Department of Human Nutrition, University of Copenhagen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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