ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Insulin Sensitivity

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

Diabetes

Cardiovascular

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]

Prevention

Intervention code [2]

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]

Insulin Sensitivity as measured by oral glucose tolerance tests.

Timepoint [1]

After each 4 week diet period.

Secondary outcome [1]

None

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Address [1]

City East Campus
North Terrace
Adelaide, SA 5000

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia

Ethics committee address [1]

City East Campus
North Terrace 
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/04/2013

Approval date [1]

22/05/2013

Ethics approval number [1]

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

A/Prof Jennifer Keogh

Address

University of South Australia
City East Campus
North Terrace
Adelaide SA 5000

Country

Australia

Phone

61 8 8302 2579

Fax

jennifer.keogh@unisa.edu.au

Contact person for public queries

Name

Jennifer Keogh

Address

University of South Australia
City East Campus
North Terrace
Adelaide SA 5000

Country

Australia

Phone

61 8 8302 2579

Fax

jennifer.keogh@unisa.edu.au

Contact person for scientific queries

Name

Jennifer Keogh

Address

University of South Australia
City East Campus
North Terrace
Adelaide SA 5000

Country

Australia

Phone

61 8 8302 2579

Fax

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

Source	Title	Year of Publication	DOI
Embase	Red meat, dairy, and insulin sensitivity: A randomized crossover intervention study.	2015	https://dx.doi.org/10.3945/ajcn.114.104976
Embase	Changes in lipids and inflammatory markers after consuming diets high in red meat or dairy for four weeks.	2017	https://dx.doi.org/10.3390/nu9080886

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically