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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - Wheat bran
Treatment: Other - 3g high MW
Treatment: Other - 4g medium MW
Treatment: Other - 3g medium MW
Treatment: Other - 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


Treatment: Other: 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.

Treatment: Other: 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

Treatment: Other: 4g medium MW
28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight

Treatment: Other: 3g medium MW
21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight

Treatment: Other: 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
Treatment: Other
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
Sex
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
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
Accrual to date
Final
367
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
Government body
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/study/NCT00981981
Trial related presentations / publications
Wolever TM, Tosh SM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Thomson BA, Duss R, Wood PJ. Physicochemical properties of oat beta-glucan influence its ability to reduce serum LDL cholesterol in humans: a randomized clinical trial. Am J Clin Nutr. 2010 Oct;92(4):723-32. doi: 10.3945/ajcn.2010.29174. Epub 2010 Jul 21.
Tosh SM, Brummer Y, Miller SS, Regand A, Defelice C, Duss R, Wolever TM, Wood PJ. Processing affects the physicochemical properties of beta-glucan in oat bran cereal. J Agric Food Chem. 2010 Jul 14;58(13):7723-30. doi: 10.1021/jf904553u.
Wolever TM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Tosh SM, Duss R. Bioactive oat beta-glucan reduces LDL cholesterol in Caucasians and non-Caucasians. Nutr J. 2011 Nov 25;10:130. doi: 10.1186/1475-2891-10-130.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00981981