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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Effect of Varying Dose and Molecular Weight on the Serum LDL-cholesterol-lowering Properties of Oat ß-glucan
Secondary ID [1] 0 0
GIL8034
Universal Trial Number (UTN)
Trial acronym
Bluebird
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan
Timepoint [1] 0 0
4 weeks
Primary outcome [2] 0 0
Correlation between serum LDL-cholesterol lowering and log(MW*C)
Timepoint [2] 0 0
4 weeks
Secondary outcome [1] 0 0
Total cholesterol
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Serum triglycerides
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Serum HDL cholesterol
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Fasting serum glucose
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Serum aspartate transaminase
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
serum c-reactive protein
Timepoint [6] 0 0
4 weeks
Secondary outcome [7] 0 0
Serum urea
Timepoint [7] 0 0
4 weeks
Secondary outcome [8] 0 0
Serum creatinine
Timepoint [8] 0 0
4 weeks
Secondary outcome [9] 0 0
Time course of changes in blood lipids
Timepoint [9] 0 0
4 weeks
Secondary outcome [10] 0 0
Blood pressure
Timepoint [10] 0 0
4 weeks
Secondary outcome [11] 0 0
Macronutrient composition of diet
Timepoint [11] 0 0
4 weeks
Secondary outcome [12] 0 0
Symptoms questionnaire
Timepoint [12] 0 0
4 weeks
Secondary outcome [13] 0 0
apolipoprotein B
Timepoint [13] 0 0
4 weeks
Secondary outcome [14] 0 0
Serum markers of cholesterol absorption and synthesis
Timepoint [14] 0 0
4 weeks

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
Minimum age
35 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Berkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Glycemic Index Laboratories, Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CreaNutrition, AG
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Guelph
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Sydney
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Laval University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/Industry
Name [5] 0 0
Reading Scientific Services Ltd.
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Toronto
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Agriculture and Agri-Food Canada
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00981981
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas MS Wolever, MD, PhD
Address 0 0
Glycemic Index Laboratories, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications