Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000033842
Ethics application status
Approved
Date submitted
13/12/2011
Date registered
9/01/2012
Date last updated
8/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of yoghurt and its probiotics on features of the metabolic syndrome, intestinal function, bone metabolism and quality of life; a randomised controlled trial.
Scientific title
In elderly persons at risk of metabolic syndrome, is yoghurt and/or its probiotics efficacious at improving features of metabolic syndrome?
Secondary ID [1] 262902 0
Nil
Universal Trial Number (UTN)
U1111-1123-9525
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 270631 0
Condition category
Condition code
Cardiovascular 270799 270799 0 0
Hypertension
Metabolic and Endocrine 270800 270800 0 0
Diabetes
Cardiovascular 270801 270801 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: 200g/d Probiotic yoghurt consumed over a total of 6 weeks

Arm 2: 3 x probiotic capsules/d consumed over a total of 6 weeks. Each capsule contains > 10 billion CFU probiotic bacteria
Intervention code [1] 269252 0
Prevention
Intervention code [2] 269253 0
Treatment: Other
Comparator / control treatment
Placebo arm 1: 250mL/d long-life milk consumed over a total of 6 weeks


Placebo arm 2: 3 x placebo capsules/dconsumed over a total of 6 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 279497 0
Change in low density lipoprotein cholesterol assessed by blood analysis
Timepoint [1] 279497 0
Baseline and 6 weeks after intervention commencement
Primary outcome [2] 279498 0
Change in systolic blood pressure assessed by sphygmomanometer
Timepoint [2] 279498 0
Baseline and 6 weeks after intervention commencement
Primary outcome [3] 279499 0
Change in fasting glucose concentration assessed by blood analysis
Timepoint [3] 279499 0
Baseline and 6 weeks after intervention commencement
Secondary outcome [1] 287750 0
Blood glucose control as indicated by glycated haemoglobin, insulin concentration and fasting blood glucose level.
Timepoint [1] 287750 0
Baseline and 6 weeks after intervention commencement
Secondary outcome [2] 287751 0
Gastrointestinal symptoms as assessed using the Irritable Bowel Syndrome Severity Scale
Timepoint [2] 287751 0
Baseline and 3 and 6 weeks after intervention commencement

Eligibility
Key inclusion criteria
1. Minimal usual probiotic intake (consuming less than 400 g yoghurt per week, and not taking probiotic supplements); AND 2. BMI greater than 25 kg/m2; AND 3. Waist circumference greater than 94 cm in men and 80cm in women OR blood pressure >120/80 mmHg
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unlikely to complete the 6 week study
2. Intolerance to dairy foods
3. Unable to attend the study centre on 4 occasions over 9 weeks
4. Current antibiotic use
5. Patients on immunosuppressive
6. Type two diabetes requiring pharmaceutical treatment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To maintain blinding of both participants and researchers, the placebo and active capsules bottles will be provided to study staff labelled with only with the study number which will preassigned according to randomisation code - see below
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of 4 intervention groups by computerised block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Participants will be blinded to capsule allocation, but not dairy allocation. The people assessing the outcomes and analysing results and data will be blinded to both capsule and dairy allocation
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4370 0
6000
Recruitment postcode(s) [2] 4371 0
6003
Recruitment postcode(s) [3] 4372 0
6004
Recruitment postcode(s) [4] 4373 0
6005
Recruitment postcode(s) [5] 4374 0
6006
Recruitment postcode(s) [6] 4375 0
6007
Recruitment postcode(s) [7] 4376 0
6008
Recruitment postcode(s) [8] 4377 0
6009
Recruitment postcode(s) [9] 4378 0
6010
Recruitment postcode(s) [10] 4379 0
6011
Recruitment postcode(s) [11] 4380 0
6014
Recruitment postcode(s) [12] 4381 0
6015
Recruitment postcode(s) [13] 4382 0
6016
Recruitment postcode(s) [14] 4383 0
6017
Recruitment postcode(s) [15] 4384 0
6018
Recruitment postcode(s) [16] 4385 0
6050
Recruitment postcode(s) [17] 4386 0
6051
Recruitment postcode(s) [18] 4387 0
6052
Recruitment postcode(s) [19] 4388 0
6059
Recruitment postcode(s) [20] 4389 0
6060
Recruitment postcode(s) [21] 4390 0
6100
Recruitment postcode(s) [22] 4391 0
6101
Recruitment postcode(s) [23] 4392 0
6102
Recruitment postcode(s) [24] 4393 0
6150
Recruitment postcode(s) [25] 4394 0
6151
Recruitment postcode(s) [26] 4395 0
6152
Recruitment postcode(s) [27] 4396 0
6153
Recruitment postcode(s) [28] 4397 0
6154
Recruitment postcode(s) [29] 4398 0
6156
Recruitment postcode(s) [30] 4399 0
6157
Recruitment postcode(s) [31] 4400 0
6158

Funding & Sponsors
Funding source category [1] 269725 0
University
Name [1] 269725 0
Bone and Vascular Research Group
Country [1] 269725 0
Australia
Primary sponsor type
Individual
Name
Professor Richard Prince
Address
Bone and Vascular Research Group
1st Floor, C Block
Department of Endocrinology and Diabetes
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 268765 0
None
Name [1] 268765 0
Address [1] 268765 0
Country [1] 268765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271691 0
the University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 271691 0
The University of Western Australia (M459)
Crawley, Perth
Western Australia 6009
Ethics committee country [1] 271691 0
Australia
Date submitted for ethics approval [1] 271691 0
Approval date [1] 271691 0
27/07/2011
Ethics approval number [1] 271691 0
RA/4/1/4873

Summary
Brief summary
This is a 6 week randomised controlled factorial study to evaluate the effects of yoghurt and its probiotics on risk of metabolic syndrome, quality of life, gastrointestinal health and bone metabolism.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33065 0
Address 33065 0
Country 33065 0
Phone 33065 0
Fax 33065 0
Email 33065 0
Contact person for public queries
Name 16312 0
Kerry Ivey
Address 16312 0
Bone and Vascular Research Group
1st Floor, C Block
Department of Endocrinology and Diabetes
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands WA 6009
Country 16312 0
Australia
Phone 16312 0
+61 (08) 9346 3478
Fax 16312 0
+61 (08) 9346 1317
Email 16312 0
[email protected]
Contact person for scientific queries
Name 7240 0
Kerry Ivey
Address 7240 0
Bone and Vascular Research Group
1st Floor, C Block
Department of Endocrinology and Diabetes
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands WA 6009
Country 7240 0
Australia
Phone 7240 0
+61 (08) 9346 3478
Fax 7240 0
+61 (08) 9346 1317
Email 7240 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe effects of probiotic bacteria on glycaemic control in overweight men and women: a randomised controlled trial2014https://doi.org/10.1038/ejcn.2013.294
N.B. These documents automatically identified may not have been verified by the study sponsor.