Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000574842
Ethics application status
Approved
Date submitted
28/05/2012
Date registered
29/05/2012
Date last updated
29/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The objective of this study is to see the effects of changing dairy intake in healthy New Zealand participants on blood levels of ruminant trans fats, and on the metabolic syndrome
Scientific title
single centre randomised controlled study to assess the effects of changing dairy intake for 1 month on components of the metabolic syndrome and on fatty acids in healthy volunteers
Secondary ID [1] 280563 0
nil known
Universal Trial Number (UTN)
U1111-1131-2385
Trial acronym
DAISY NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metabolic syndrome 286566 0
Condition category
Condition code
Metabolic and Endocrine 286836 286836 0 0
Metabolic disorders
Diet and Nutrition 286842 286842 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1- increased dairy consumption by 2 standards servings/day
Arm 2- eliminate all dairy as much as possible
Arm 3- no change
for 4 weeks. All participants had a one to one session with a study co ordinator with exerience in giving dietary advice on on one. A sheet with tips on how to change dairy intake(when applicable) was also given to all participants
Intervention code [1] 284947 0
Lifestyle
Intervention code [2] 284950 0
Prevention
Comparator / control treatment
no change
Control group
Active

Outcomes
Primary outcome [1] 287195 0
To determine whether dietary advice to increase or decrease dairy intake significantly changes plasma levels of vaccenic acid and palmitelaidic acid in participants.
Timepoint [1] 287195 0
at 1 month
Secondary outcome [1] 297596 0
To determine whether dietary changes in TFA are associated with changes in serum CRP levels
Timepoint [1] 297596 0
at 1 month
Secondary outcome [2] 297597 0
To determine whether dietary changes in TFA are associated with changes in BP levels at the 1 month clinic visit
Timepoint [2] 297597 0
at 1 month
Secondary outcome [3] 297598 0
To determine whether dietary changes in TFA are associated with changes in plasma lipids levels
Timepoint [3] 297598 0
at 1 month
Secondary outcome [4] 297599 0
To determine whether dietary changes in TFA are associated with changes in insulin resistance levels as calculated using the HOMA model of fasting serum insulin and plasma glucose levels
Timepoint [4] 297599 0
at 1 month

Eligibility
Key inclusion criteria
Aged over 18 years of age
Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unwilling to trial dietary intervention
2. lactose intolerant/milk allergy
3. pregnant/lactating
4. Known vitamin D deficiency or hypocalcaemia
5. Osteoporosis.
6. Inflammatory conditions e.g. rheumatoid arthritis
7. On a statin
8. Known cardiovascular disease (stroke, ischemic heart disease, peripheral vascular disease)

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)
Allocation was concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random allocation- blocks of 60
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 4335 0
New Zealand
State/province [1] 4335 0

Funding & Sponsors
Funding source category [1] 285328 0
Charities/Societies/Foundations
Name [1] 285328 0
Greenlane Reseach and Educational Fund
Country [1] 285328 0
New Zealand
Primary sponsor type
Hospital
Name
auckland city hospital
Address
park Rd, grafton, Auckland,1030
Country
New Zealand
Secondary sponsor category [1] 284182 0
None
Name [1] 284182 0
Address [1] 284182 0
Country [1] 284182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287343 0
Northern X
Ethics committee address [1] 287343 0
3rd floor, Unisys building
650 Great South Rd
Penrose
Auckland
1030
Ethics committee country [1] 287343 0
New Zealand
Date submitted for ethics approval [1] 287343 0
Approval date [1] 287343 0
29/11/2010
Ethics approval number [1] 287343 0

Summary
Brief summary
It is well established that industrial trans fatty acids (TFA) are harmful to health however, little is known about the effects of the natural TFA found in dairy. Some like the FDA feel that all TFA is harmful and have recommended that intake be limited as much as possible. An observational study by CVRU suggests that dairy TFAs may be harmful to cardiac health. Conversely a recent Harvard University observational cross sectional study observed that these isomers reduced insulin resistance. This interventional study is a randomised clinical study in 180 participants and assesses the effects of changing dairy intake on TFA, inflammatory markers, lipids, insulin resistance and anthropomorphic parameters.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34230 0
Address 34230 0
Country 34230 0
Phone 34230 0
Fax 34230 0
Email 34230 0
Contact person for public queries
Name 17477 0
jocelyne benatar
Address 17477 0
cardiology level 3
auckland city hospital
park rd
grafton
1030
Country 17477 0
New Zealand
Phone 17477 0
+64 9 3074949
Fax 17477 0
Email 17477 0
[email protected]
Contact person for scientific queries
Name 8405 0
jocelyne benatar
Address 8405 0
cardiology level 3
auckland city hospital
park rd
grafton
1030
Country 8405 0
New Zealand
Phone 8405 0
+64 9 3074949
Fax 8405 0
Email 8405 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
EmbaseAltered dairy protein intake does not alter circulatory branched chain amino acids in healthy adults: A randomized controlled trial.2018https://dx.doi.org/10.3390/nu10101510
N.B. These documents automatically identified may not have been verified by the study sponsor.