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

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01317264
First received: March 11, 2011
Last updated: March 16, 2011
Last verified: November 2009
  Purpose

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


Condition Intervention
Healthy
Other: no β-glucan
Other: oat β-glucan
Other: barley β-glucan
Other: mutant-barley β-glucan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • change in total and LDL cholesterol concentration [ Time Frame: fasting blood sample at baseline and day 21 ] [ Designated as safety issue: No ]
  • pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces) [ Time Frame: average over three days at baseline and after 3 weeks ] [ Designated as safety issue: No ]
  • weight [ Time Frame: at baseline and after 1, 2 and 3 weeks ] [ Designated as safety issue: No ]
  • food intake (in 4d records) [ Time Frame: at baseline and after 3 weeks ] [ Designated as safety issue: No ]
  • height [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • appetite sensation (in meal tests) [ Time Frame: 3h appetite registrations at baseline and on day 21 ] [ Designated as safety issue: No ]
  • metabolomics, isoprostanes (in 24h urine) [ Time Frame: at baseline and after 3 weeks ] [ Designated as safety issue: No ]
  • metabolomics (in 72h feces) [ Time Frame: average over 3 days at baseline and after 3 weeks ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: at baseline and on day 21 ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo milk drink Other: no β-glucan
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 Other: 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 Name: "PromOat",Biovelop, Kimstad, Sweden
Experimental: Milk drink with barley β-glucan Other: 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 Other: 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

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317264

Locations
Denmark
University of Copenhagen
Copenhagen, Denmark, 1165
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Arne Astrup, Professor Department of human nutrition, University of Copenhagen
  More Information

No publications provided

Responsible Party: Susanne Gjedsted Bügel, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01317264     History of Changes
Other Study ID Numbers: M196
Study First Received: March 11, 2011
Last Updated: March 16, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
β-glucan
cholesterol
bile acids
blood glucose
appetite

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014