Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000441718
Ethics application status
Approved
Date submitted
16/04/2013
Date registered
17/04/2013
Date last updated
4/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Red meat, dairy and insulin sensitivity
Scientific title
The effect of a high red meat diet and a high dairy diet on insulin sensitivity in people with normal and with impaired glucose tolerance as measured by oral glucose tolerance tests.
Secondary ID [1] 282348 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin Sensitivity 288912 0
Condition category
Condition code
Diet and Nutrition 289251 289251 0 0
Obesity
Metabolic and Endocrine 289252 289252 0 0
Diabetes
Cardiovascular 289253 289253 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a dietary intervention study to test the impact of three diets on insulin sensitivity:
1. A high lean red meat diet (200g-250g/day with minimal dairy for 6 days/week)
2. A high low-fat dairy diet (4-6 serves/day 6 days/week with reduced chicken/fish, <150g/day) and no red meat
3. A diet with no dairy or red meat with 200-250g meat coming from chicken, fish or other sources.
All dietary periods will be 4 weeks long, weight stable and have a 2 week wash-out period in between. All dietary periods will be randomised.
Overweight and obese volunteers (BMI 25-45) over the age of 20, will be divided into two groups: those with normal glucose tolerance and those with impaired glucose tolerance as demonstrated by a 75g oral glucose tolerance test administered after recruitment. All participants will follow the three diets.
Height and weight will be measured at baseline, along with lean body mass which will be assessed by a DEXA scan. Weight will be measured at the beginning, middle and end of each 4-week diet period. A 75g oral glucose tolerance test will be performed at baseline and at the end of each diet period with blood samples taken at baseline, 30, 60 and 90 and 120 minutes for measurements of insulin and glucose. Instructions for each diet will be provided at the beginning of each intervention, and dietary compliance will be assessed by daily checklists and by weighed food records.
Intervention code [1] 286969 0
Prevention
Intervention code [2] 286985 0
Lifestyle
Comparator / control treatment
Two groups; one with normal glucose tolerance and one with impaired glucose tolerance. All participants will follow the same three diets.
Control group
Active

Outcomes
Primary outcome [1] 289362 0
Insulin Sensitivity as measured by oral glucose tolerance tests.
Timepoint [1] 289362 0
After each 4 week diet period.
Secondary outcome [1] 302317 0
None
Timepoint [1] 302317 0
none

Eligibility
Key inclusion criteria
Men and women aged over 20
Divided into two groups - normal glucose tolerance and impaired glucose tolerance
Eligible BMI >25
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major metabolic illness such as kidney or liver disease; cardiovascular disease, type 2 diabetes; anyone on drugs influencing glucose metabolism (eg Metformin)

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Diet order will be randomised using a computer generated sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
11/07/2013
Date of last participant enrolment
Anticipated
Actual
21/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287107 0
University
Name [1] 287107 0
University of South Australia
Country [1] 287107 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 285888 0
None
Name [1] 285888 0
None
Address [1] 285888 0
None
Country [1] 285888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289121 0
University of South Australia
Ethics committee address [1] 289121 0
City East Campus
North Terrace
Adelaide SA 5000
Ethics committee country [1] 289121 0
Australia
Date submitted for ethics approval [1] 289121 0
15/04/2013
Approval date [1] 289121 0
22/05/2013
Ethics approval number [1] 289121 0

Summary
Brief summary
The aim is to investigate the effect on insulin sensitivity of a high lean red meat diet with minimal dairy; a high dairy diet with no red meat; and a diet that has no red meat and minimal dairy with protein coming from chicken, fish and other sources. Evidence is conflicting about the benefits or risks of consuming meat and dairy products and there is little understanding of the mechanisms behind the findings observed in epidemiological studies. The primary hypothesis was that the red meat diet would produce greater insulin resistance than the high dairy diet with secondary hypotheses that the high dairy diet would produce greater insulin sensitivity than the diet without dairy and that these changes would be greater in those with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) than in those with normal glucose tolerance (NGT).
Trial website
Trial related presentations / publications
Turner, K. M., Keogh, J. B., & Clifton, P. M. (2015). Red meat, dairy, and insulin sensitivity: a randomized crossover intervention study. The American journal of clinical nutrition, 101(6), 1173-1179.
Public notes

Contacts
Principal investigator
Name 39338 0
A/Prof Jennifer Keogh
Address 39338 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 39338 0
Australia
Phone 39338 0
61 8 8302 2579
Fax 39338 0
Email 39338 0
jennifer.keogh@unisa.edu.au
Contact person for public queries
Name 39339 0
A/Prof Jennifer Keogh
Address 39339 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 39339 0
Australia
Phone 39339 0
61 8 8302 2579
Fax 39339 0
Email 39339 0
jennifer.keogh@unisa.edu.au
Contact person for scientific queries
Name 39340 0
A/Prof Jennifer Keogh
Address 39340 0
University of South Australia
City East Campus
North Terrace
Adelaide SA 5000
Country 39340 0
Australia
Phone 39340 0
61 8 8302 2579
Fax 39340 0
Email 39340 0
jennifer.keogh@unisa.edu.au

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
EmbaseChanges in lipids and inflammatory markers after consuming diets high in red meat or dairy for four weeks.2017https://dx.doi.org/10.3390/nu9080886
EmbaseRed meat, dairy, and insulin sensitivity: A randomized crossover intervention study.2015https://dx.doi.org/10.3945/ajcn.114.104976
N.B. These documents automatically identified may not have been verified by the study sponsor.