Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00981981
Registration number
NCT00981981
Ethics application status
Date submitted
18/09/2009
Date registered
22/09/2009
Date last updated
21/06/2011
Titles & IDs
Public title
Effect of the Molecular Weight of Oat ß-glucan on Its Ability to Lower Serum Cholesterol
Query!
Scientific title
Effect of Varying Dose and Molecular Weight on the Serum LDL-cholesterol-lowering Properties of Oat ß-glucan
Query!
Secondary ID [1]
0
0
GIL8034
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Bluebird
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Other metabolic disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - Wheat bran
Other interventions - 3g high MW
Other interventions - 4g medium MW
Other interventions - 3g medium MW
Other interventions - 4g low MW
Placebo Comparator: Control - Wheat bran cereal
Active Comparator: 3g high MW - Cereal containing 3g high molecular weight oat beta glucan
Active Comparator: 4g medium MW - Cereal containing 4g oat beta glucan with medium molecular weight
Active Comparator: 3g medium MW - Cereal containing 3g oat beta glucan with medium molecular weight
Active Comparator: 4g low MW - Cereal containing 4g oat beta glucan with low molecular weight
Other interventions: Wheat bran
21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan.
Other interventions: 3g high MW
20.2 grams per day of ready to eat cereal containing 6g total dietary fiber and 3g oat beta glucan with high molecular weight
Other interventions: 4g medium MW
28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight
Other interventions: 3g medium MW
21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight
Other interventions: 4g low MW
28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
4 weeks
Query!
Primary outcome [2]
0
0
Correlation between serum LDL-cholesterol lowering and log(MW*C)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
4 weeks
Query!
Secondary outcome [1]
0
0
Total cholesterol
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
4 weeks
Query!
Secondary outcome [2]
0
0
Serum triglycerides
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
4 weeks
Query!
Secondary outcome [3]
0
0
Serum HDL cholesterol
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
4 weeks
Query!
Secondary outcome [4]
0
0
Fasting serum glucose
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
4 weeks
Query!
Secondary outcome [5]
0
0
Serum aspartate transaminase
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
4 weeks
Query!
Secondary outcome [6]
0
0
serum c-reactive protein
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
4 weeks
Query!
Secondary outcome [7]
0
0
Serum urea
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
4 weeks
Query!
Secondary outcome [8]
0
0
Serum creatinine
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
4 weeks
Query!
Secondary outcome [9]
0
0
Time course of changes in blood lipids
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
4 weeks
Query!
Secondary outcome [10]
0
0
Blood pressure
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
4 weeks
Query!
Secondary outcome [11]
0
0
Macronutrient composition of diet
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
4 weeks
Query!
Secondary outcome [12]
0
0
Symptoms questionnaire
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
4 weeks
Query!
Secondary outcome [13]
0
0
apolipoprotein B
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
4 weeks
Query!
Secondary outcome [14]
0
0
Serum markers of cholesterol absorption and synthesis
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
4 weeks
Query!
Eligibility
Key inclusion criteria
- body mass index 18.5 to 40.0 kg/m^2
- no intention to lose or gain weight
- fasting total cholesterol 5.0 to 8.0 mmol/L
- fasting LDL cholesterol 3.0 to 5.0 mmol/L
- consuming diet containing <15% energy from saturated fat
Query!
Minimum age
35
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- use of any cholesterol-lowering drug, herbal or nutritional supplement
- regular consumption of oatmeal, oat bran or psyllium - containing cereals
- fasting serum triglycerides >4.0mmol/L
- serum aspartate transaminase >1.5 times upper limit of normal
- serum urea or creatinine >1.8 times upper limit of normal
- presence of diabetes or fasting glucose >6.9mmol/L
- presence or recent major surgical or medical event
- allergy to wheat or oats
- presence of condition or drug which alters digestion or absorption of foods
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
367
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2006 - Sydney
Query!
Recruitment outside Australia
Country [1]
0
0
Canada
Query!
State/province [1]
0
0
Ontario
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Quebec
Query!
Country [3]
0
0
United Kingdom
Query!
State/province [3]
0
0
Berkshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Glycemic Index Laboratories, Inc
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
CreaNutrition, AG
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
University of Guelph
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
University of Sydney
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
Laval University
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Commercial sector/Industry
Query!
Name [5]
0
0
Reading Scientific Services Ltd.
Query!
Address [5]
0
0
Query!
Country [5]
0
0
Query!
Other collaborator category [6]
0
0
Other
Query!
Name [6]
0
0
University of Toronto
Query!
Address [6]
0
0
Query!
Country [6]
0
0
Query!
Other collaborator category [7]
0
0
Other
Query!
Name [7]
0
0
Agriculture and Agri-Food Canada
Query!
Address [7]
0
0
Query!
Country [7]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purposes of this study were:
1. To determine if a breakfast cereal containing 3g of high molecular weight oat
beta-glucan fiber would lower low-density lipoprotein (LDL) - cholesterol (the "bad"
cholesterol) compared to a control cereal containing wheat fiber.
2. To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced
when the molecular weight of the fiber was reduced.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00981981
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Thomas MS Wolever, MD, PhD
Query!
Address
0
0
Glycemic Index Laboratories, Inc
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00981981
Download to PDF