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

University of Copenhagen

Status: Completed

Conditions: Healthy

Treatments: Other: no β-glucan; Other: mutant-barley β-glucan; Other: barley β-glucan; Other: oat β-glucan

Study type: Interventional

Funder types: Other

Identifiers

NCT01317264

M196

Details and patient eligibility

About

The aim of this study is to investigate the potential disease preventive effects of β-glucans from oat and barley.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 4 patient groups, including a placebo group

Placebo milk drink

Placebo Comparator group

Treatment:

Other: no β-glucan

Millk drink with oat β-glucan

Experimental group

Treatment:

Other: oat β-glucan

Milk drink with barley β-glucan

Experimental group

Treatment:

Other: barley β-glucan

Milk drink with mutant-barley β-glucan

Experimental group

Treatment:

Other: mutant-barley β-glucan