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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
Scientific title
A meta-analysis of randomized studies evaluating the effects of increasing dairy food intake on cardio-metabolic risk factors.
Secondary ID [1] 282269 0
nil
Universal Trial Number (UTN)
U1111-1141-6173
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome
288804 0
Condition category
Condition code
Cardiovascular 289159 289159 0 0
Hypertension
Metabolic and Endocrine 289160 289160 0 0
Other metabolic disorders
Diet and Nutrition 289161 289161 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 286899 0
Not applicable
Comparator / control treatment
usual diet
Control group
Active

Outcomes
Primary outcome [1] 289270 0
To see effects of increasing dairy on blood pressure, HOMA, weight, waist circumfernce, lipids, C- reactive protein
Timepoint [1] 289270 0
one month minimum (no maximum timepoint)
Secondary outcome [1] 302136 0
To see effects of increasing dairy on C reactive protein
Timepoint [1] 302136 0
One month minimum (no maximum timepoint)

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 4989 0
New Zealand
State/province [1] 4989 0

Funding & Sponsors
Funding source category [1] 287037 0
University
Name [1] 287037 0
university of auckland
Address [1] 287037 0
22 Princess St
Auckland 1030
Country [1] 287037 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
22 princess st
auckland 1030
Country
New Zealand
Secondary sponsor category [1] 285815 0
None
Name [1] 285815 0
Address [1] 285815 0
Country [1] 285815 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289071 0
not applicable- meta analysis
Ethics committee address [1] 289071 0
Ethics committee country [1] 289071 0
New Zealand
Date submitted for ethics approval [1] 289071 0
08/04/2013
Approval date [1] 289071 0
Ethics approval number [1] 289071 0

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
Trial website
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
Public notes

Contacts
Principal investigator
Name 39090 0
Dr jocelyne benatar
Address 39090 0
Cardiovascular Research Unit
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Country 39090 0
New Zealand
Phone 39090 0
+6421893886
Fax 39090 0
Email 39090 0
jbenatar@adhb.govt.nz
Contact person for public queries
Name 39091 0
Dr jocelyne benatar
Address 39091 0
Cardiovascular Research Unit
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Country 39091 0
New Zealand
Phone 39091 0
+6421893886
Fax 39091 0
Email 39091 0
jbenatar@adhb.govt.nz
Contact person for scientific queries
Name 39092 0
Dr jocelyne benatar
Address 39092 0
Cardiovascular Research Unit
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Country 39092 0
New Zealand
Phone 39092 0
+6421893886
Fax 39092 0
Email 39092 0
jbenatar@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary