Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial registered on ANZCTR


Registration number
ACTRN12615000164594
Ethics application status
Approved
Date submitted
1/12/2014
Date registered
19/02/2015
Date last updated
4/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effects of red meat and dairy on glucose metabolism
Scientific title
The acute effect of a high red meat diet and a high dairy diet on glucose metabolism in overweight and obese adults with normal and with impaired glucose tolerance as measured by meal tolerance tests.
Secondary ID [1] 285763 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin sensitivity 293647 0
Condition category
Condition code
Diet and Nutrition 293942 293942 0 0
Obesity
Metabolic and Endocrine 293943 293943 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A crossover meal study will be performed to evaluate the acute effects of red meat and dairy on glucose and insulin levels. Two isoenergetic test meals, equal in protein, carbohydrate and fat content, with one meal containing red meat and the other containing dairy products will be consumed by each participant on two separate occasions, one week apart. The red meat meal is made up of 90g beef, 59g bread, 13g butter and 250g of orange juice. The dairy meal is made up of 260g milk, 75g yoghurt, 36g cheese, 62g bread and 11g margarine. Overweight and obese adults (BMI >25) over the age of 20 will be recruited for this study. They will be separated into two groups; normal glucose tolerance and impaired glucose tolerance, as established by a 75g OGTT performed at the baseline visit, or from a previous medical diagnosis of impaired glucose tolerance.
Participants will attend on three occasions following an overnight fast. The first visit is a screening visit and participants will have their fasting blood glucose concentrations determined from capillary whole blood. A 75g OGTT will be conducted, with a second glucose concentration measured 120 minutes after consumption of the drink. The glucometer readings will determine which group the participants are assigned to. Body mass will be measured by dual-energy x-ray absorptiometry (DEXA).
Height will be measured at the first visit and weight at each visit. Venous blood samples will be taken at baseline, then 30, 60, 90, 120, 150 and 180 minutes after consumption of each test meal for measurement of glucose, insulin, C-peptide and triglycerides.
Intervention code [1] 290722 0
Prevention
Intervention code [2] 290723 0
Lifestyle
Comparator / control treatment
Two groups of participants; one with normal glucose tolerance and one with impaired glucose tolerance. All participants have both meals.
Control group
Active

Outcomes
Primary outcome [1] 293718 0
Insulin sensitivity as assessed by meal tolerance tests.
Plasma glucose will be measured using an automated spectrophotometric analyzer and serum insulin will be measured by commercial ELISA kits
Timepoint [1] 293718 0
Blood samples are taken fasting, and then 30, 60, 90, 120, 150 and 180 minutes after consumption of each test meal.
Secondary outcome [1] 311655 0
Triglyceride concentrations as assessed by meal tolerance tests. Triglycerides will be measured using an automated spectrophotometric analyser.
Timepoint [1] 311655 0
Blood samples are taken fasting, and then 30, 60, 90, 120, 150 and 180 minutes after consumption of each test meal.
Secondary outcome [2] 312968 0
C-peptide concentrations as assessed by meal tolerance tests. C-peptide will be measured by commercial ELISA kits.
Timepoint [2] 312968 0
Blood samples are taken fasting, and then 30, 60, 90, 120, 150 and 180 minutes after consumption of each test meal.

Eligibility
Key inclusion criteria
Men and women with a BMI >25, with normal glucose tolerance or with impaired fasting glucose or impaired glucose tolerance.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Major metabolic illness such as kidney or liver 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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2014
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
30/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 290330 0
University
Name [1] 290330 0
University of South Australia
Country [1] 290330 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East Campus
North Terrace and Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 289048 0
None
Name [1] 289048 0
Address [1] 289048 0
Country [1] 289048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292036 0
University of South Australia
Ethics committee address [1] 292036 0
Ethics committee country [1] 292036 0
Australia
Date submitted for ethics approval [1] 292036 0
Approval date [1] 292036 0
16/07/2014
Ethics approval number [1] 292036 0
HREC 033062

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53158 0
A/Prof Jennifer Keogh
Address 53158 0
University of South Australia
PO BOX 2471
Adelaide SA 5000
Country 53158 0
Australia
Phone 53158 0
+61 8 8302 2579
Fax 53158 0
Email 53158 0
[email protected]
Contact person for public queries
Name 53159 0
Jennifer Keogh
Address 53159 0
University of South Australia
PO BOX 2471
Adelaide SA 5000
Country 53159 0
Australia
Phone 53159 0
+61 8 8302 2579
Fax 53159 0
Email 53159 0
[email protected]
Contact person for scientific queries
Name 53160 0
Jennifer Keogh
Address 53160 0
University of South Australia
PO BOX 2471
Adelaide SA 5000
Country 53160 0
Australia
Phone 53160 0
+61 8 8302 2579
Fax 53160 0
Email 53160 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
No additional documents have been identified.