Skip to main content
OpenTrials
Completed

NCT Number: NCT01317264

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, 1165, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no β-glucan

Other

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

oat β-glucan

Other

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

Other names: "PromOat",Biovelop, Kimstad, Sweden

barley β-glucan

Other

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

mutant-barley β-glucan

Other

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

Primary outcomes

  1. change in total and LDL cholesterol concentration

    Time frame: fasting blood sample at baseline and day 21

  2. pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces)

    Time frame: average over three days at baseline and after 3 weeks

  3. weight

    Time frame: at baseline and after 1, 2 and 3 weeks

  4. food intake (in 4d records)

    Time frame: at baseline and after 3 weeks

  5. height

    Time frame: at baseline

Secondary outcomes

  1. 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

  2. appetite sensation (in meal tests)

    Time frame: 3h appetite registrations at baseline and on day 21

  3. metabolomics, isoprostanes (in 24h urine)

    Time frame: at baseline and after 3 weeks

  4. metabolomics (in 72h feces)

    Time frame: average over 3 days at baseline and after 3 weeks

  5. blood pressure

    Time frame: at baseline and on day 21

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 17, 2011
Registry last updated
Mar 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.