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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
no β-glucan
oat β-glucan
barley β-glucan
mutant-barley β-glucan
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring β-glucan, cholesterol, bile acids, blood glucose, appetite

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo milk drink

Millk drink with oat β-glucan

Milk drink with barley β-glucan

Milk drink with mutant-barley β-glucan

Arm Description

Outcomes

Primary Outcome Measures

change in total and LDL cholesterol concentration
pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces)
weight
food intake (in 4d records)
height

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)
appetite sensation (in meal tests)
metabolomics, isoprostanes (in 24h urine)
metabolomics (in 72h feces)
blood pressure

Full Information

First Posted
March 11, 2011
Last Updated
March 16, 2011
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01317264
Brief Title
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

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
β-glucan, cholesterol, bile acids, blood glucose, appetite

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo milk drink
Arm Type
Placebo Comparator
Arm Title
Millk drink with oat β-glucan
Arm Type
Experimental
Arm Title
Milk drink with barley β-glucan
Arm Type
Experimental
Arm Title
Milk drink with mutant-barley β-glucan
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
no β-glucan
Intervention Description
daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days
Intervention Type
Other
Intervention Name(s)
oat β-glucan
Other Intervention Name(s)
"PromOat",Biovelop, Kimstad, Sweden
Intervention Description
daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days
Intervention Type
Other
Intervention Name(s)
barley β-glucan
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
mutant-barley β-glucan
Intervention Description
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 Outcome Measure Information:
Title
change in total and LDL cholesterol concentration
Time Frame
fasting blood sample at baseline and day 21
Title
pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces)
Time Frame
average over three days at baseline and after 3 weeks
Title
weight
Time Frame
at baseline and after 1, 2 and 3 weeks
Title
food intake (in 4d records)
Time Frame
at baseline and after 3 weeks
Title
height
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
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
Title
appetite sensation (in meal tests)
Time Frame
3h appetite registrations at baseline and on day 21
Title
metabolomics, isoprostanes (in 24h urine)
Time Frame
at baseline and after 3 weeks
Title
metabolomics (in 72h feces)
Time Frame
average over 3 days at baseline and after 3 weeks
Title
blood pressure
Time Frame
at baseline and on day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Professor
Organizational Affiliation
Department of human nutrition, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
ZIP/Postal Code
1165
Country
Denmark

12. IPD Sharing Statement

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

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