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 registered on ANZCTR
Registration number
ACTRN12613000401752
Ethics application status
Not yet submitted
Date submitted
8/04/2013
Date registered
12/04/2013
Date last updated
9/12/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Effects of increasing dairy food on cardio-metabolic risk factors
Query!
Scientific title
A meta-analysis of randomized studies evaluating the effects of increasing dairy food intake on cardio-metabolic risk factors.
Query!
Secondary ID [1]
282269
0
nil
Query!
Universal Trial Number (UTN)
U1111-1141-6173
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome
288804
0
Query!
Condition category
Condition code
Cardiovascular
289159
289159
0
0
Query!
Hypertension
Query!
Metabolic and Endocrine
289160
289160
0
0
Query!
Other metabolic disorders
Query!
Diet and Nutrition
289161
289161
0
0
Query!
Other diet and nutrition disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
A meta- analysis assessing the effects of dietary interventions to increase dairy intake for at least one one month- all randomised control studies with dairy as intervention that reported any of the outcome measures in healthy populations was eligible. All databases (science direct, Google, Chochrane database, medline) will be searched. Exclusion are if population has cardiovascular disease or diabetes, or if multiple interventions used (e.g. dairy with caloric restriction). All studies reported from 1990 to 2013 will b eligible
Query!
Intervention code [1]
286899
0
Not applicable
Query!
Comparator / control treatment
usual diet
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
289270
0
To see effects of increasing dairy on blood pressure, HOMA, weight, waist circumfernce, lipids, C- reactive protein
Query!
Assessment method [1]
289270
0
Query!
Timepoint [1]
289270
0
one month minimum (no maximum timepoint)
Query!
Secondary outcome [1]
302136
0
To see effects of increasing dairy on C reactive protein
Query!
Assessment method [1]
302136
0
Query!
Timepoint [1]
302136
0
One month minimum (no maximum timepoint)
Query!
Eligibility
Key inclusion criteria
Randomised studies with increased dairy for at least 4 weeks without other major concomitant interventions (e.g. caloric restriction, multiple dietary interventions.), have an appropriate control group without this dietary intervention, and sufficient data to calculate estimates of effect with standard deviations on weight, waist circumference, blood pressure, lipids, insulin resistance and inflammatory markers.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Studies are excluded if they were observational or otherwise non-randomized; were commentaries, reviews, or duplicate publications from the same study. We are restricting to studies in healthy adults who did not have diabetes, hypertension or vascular disease. We include both feeding trials and trials that utilized dietary advice; for both designs, the average change in dairy consumption was assessed.
Query!
Study design
Purpose
Screening
Query!
Duration
Longitudinal
Query!
Selection
Defined population
Query!
Timing
Retrospective
Query!
Statistical methods / analysis
Cases will be compared only with controls within the same study. For those studies with 3 treatment groups, comparison will be made with control and the high dairy group. Differences by dietary intervention are calculated as weighted mean difference divided by variance, expressed as a sample weighted mean effect size (95% confidence interval). A test for homogeneity will be performed for each cardio metabolic risk evaluated. Stratified analysis will be performed if there is enough data
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
15/04/2013
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
13
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
4989
0
New Zealand
Query!
State/province [1]
4989
0
Query!
Funding & Sponsors
Funding source category [1]
287037
0
University
Query!
Name [1]
287037
0
university of auckland
Query!
Address [1]
287037
0
22 Princess St
Auckland 1030
Query!
Country [1]
287037
0
New Zealand
Query!
Primary sponsor type
University
Query!
Name
University of Auckland
Query!
Address
22 princess st
auckland 1030
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
285815
0
None
Query!
Name [1]
285815
0
Query!
Address [1]
285815
0
Query!
Country [1]
285815
0
Query!
Ethics approval
Ethics application status
Not yet submitted
Query!
Ethics committee name [1]
289071
0
not applicable- meta analysis
Query!
Ethics committee address [1]
289071
0
Query!
Ethics committee country [1]
289071
0
New Zealand
Query!
Date submitted for ethics approval [1]
289071
0
08/04/2013
Query!
Approval date [1]
289071
0
Query!
Ethics approval number [1]
289071
0
Query!
Summary
Brief summary
This meta analysis is evaluating the effects of increasing dairy intake on a number of risk factors for heart disease; blood pressure, cholesterol, waist circumference, weight and insulin resistance. All randomised studies that have increasing dairy as an intervention wil be assessed. An analysis will be done to see if dairy does indeed have any effect on the risk of heart disease
Query!
Trial website
Query!
Trial related presentations / publications
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0076480
Published: October 11, 2013
DOI: 10.1371/journal.pone.0076480
Query!
Public notes
Query!
Contacts
Principal investigator
Name
39090
0
Dr jocelyne benatar
Query!
Address
39090
0
Cardiovascular Research Unit
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Query!
Country
39090
0
New Zealand
Query!
Phone
39090
0
+6421893886
Query!
Fax
39090
0
Query!
Email
39090
0
[email protected]
Query!
Contact person for public queries
Name
39091
0
Dr jocelyne benatar
Query!
Address
39091
0
Cardiovascular Research Unit
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Query!
Country
39091
0
New Zealand
Query!
Phone
39091
0
+6421893886
Query!
Fax
39091
0
Query!
Email
39091
0
[email protected]
Query!
Contact person for scientific queries
Name
39092
0
Dr jocelyne benatar
Query!
Address
39092
0
Cardiovascular Research Unit
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Query!
Country
39092
0
New Zealand
Query!
Phone
39092
0
+6421893886
Query!
Fax
39092
0
Query!
Email
39092
0
[email protected]
Query!
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
No additional documents have been identified.
Download to PDF