Clinical trial NCT01317264: β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
Official title: β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: β-glucan
cholesterol
bile acids
blood glucose
appetite
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in total and LDL cholesterol concentration
timeFrame: fasting blood sample at baseline and day 21
measure: pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces)
timeFrame: average over three days at baseline and after 3 weeks
measure: weight
timeFrame: at baseline and after 1, 2 and 3 weeks
measure: food intake (in 4d records)
timeFrame: at baseline and after 3 weeks
measure: height
timeFrame: at baseline
Secondary outcomes:
measure: insulin, glucose, IL-6, CRP, TNF-α, fibrinogen, PAI-1, appetite regulation peptides, alkylresorcinol, metabolomics (in fasting and meal test blood samples)
timeFrame: fasting blood sample at baseline and on day 21
measure: appetite sensation (in meal tests)
timeFrame: 3h appetite registrations at baseline and on day 21
measure: metabolomics, isoprostanes (in 24h urine)
timeFrame: at baseline and after 3 weeks
measure: metabolomics (in 72h feces)
timeFrame: average over 3 days at baseline and after 3 weeks
measure: blood pressure
timeFrame: at baseline and on day 21
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: Department of human nutrition, University of Copenhagen
name: Arne Astrup, Professor
role: PRINCIPAL_INVESTIGATOR
References: