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Trial registered on ANZCTR


Registration number
ACTRN12610000562077
Ethics application status
Approved
Date submitted
12/07/2010
Date registered
12/07/2010
Date last updated
12/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Real Dairy Diets for Human Health
Scientific title
Immune and metabolic responses to high versus low fat and dairy versus non-dairy breakfasts in lean and overweight males (aged 40-60 years).
Secondary ID [1] 252193 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-meal inflammatory and metabolic responses to high and low fat meals. 257726 0
Condition category
Condition code
Diet and Nutrition 257898 257898 0 0
Obesity
Inflammatory and Immune System 257900 257900 0 0
Normal development and function of the immune system
Cardiovascular 257901 257901 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Male participants (aged 40-60 years) will randomise to ingest differing breakfasts. Four possible breakfast meals (treatment arms) will be provided. These include; Arm 1: High fat dairy breakfast. Arm 2: High fat non-dairy breakfast. Arm 3: Low fat dairy brekfast. Arm 4: Low fat non-dairy breakfast. Subjects will be randomised to ingest either arms 1 and 2 or 3 and 4, with sequence of each meal being further randomly allocated.

Arms 1 and 2 are equal in total energy (3120kJ Arm 1 versus 3250kJ Arm 2), and equal for macronutrients (54g fat, 20g protein and 37g carbohydrate). Arms 3 and 4 are equal in total energy (1860kJ Arm 3 versus 2010kJ Arm 4), and equal for macronutrients (19g fat, 29g protein and 39g carbohydrate).

Subjects will arrive at the laboratory in a fasted stated. Breakfast will be supplied and eaten within 15 minutes. Following each breakfast, blood samples, as well as adipose and muscle samples (via biopsy) will be taken. These will be used to determine what biological and metabolic responses occur after food ingestion. Breakfasts meals will be separated by a 4 week wash-out period.
Intervention code [1] 256784 0
Lifestyle
Intervention code [2] 256786 0
Prevention
Comparator / control treatment
Men will be classified as either lean and healthy or overweight with the metabolic syndrome (at risk of type 2 diabetes and heart disease)
Control group
Active

Outcomes
Primary outcome [1] 258762 0
Immune responses to a meal: - inflammatory signals and gene expression in immune cells found in the blood
Timepoint [1] 258762 0
Blood is taken before the meal and at hourly intervals after the meal for 6 hours.
Secondary outcome [1] 264819 0
Adipose and muscle responses to a meal; - Adipose and muscle gene and protein signaling responses to the meal will be measured.
Timepoint [1] 264819 0
Adipose and skeletal muscle will be taken using needle biopsy before the meal and again 2 and 4 hours after each meal.

Eligibility
Key inclusion criteria
Lean subjects are included based on a waist circumference less than 94cm.

Metabolic Syndrome subjects are included based on having a waist circumference greater than 94cm, plus two of the following; fasting serum triglycerides greater or equal to 1.7mmol/l, fasting plasma glucose greater or equal to 5.6mmol/l; serum high density lipoprotein cholesterol (HDL) less than 1.03mg/l; systolic blood pressure either greater than or equal to systolic 130mmHG.
Minimum age
40 Years
Maximum age
60 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
The presence of confirmed diabetes or heart 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)
Participants will be complete a medical questionnaire, physical examination and undergo a blood test. Based on weight and heart disease risk, participants will be recruited into one of two groups (lean or metabolic syndrome). Subjects will then be randomly allocated (allocation is not concealed) to one of two interventions, either high or low-fat breakfasts. Within each intervention arm the subjects will be further randomised to recieve either a dairy breakfast or a non-dairy breakfast.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence generated by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257273 0
Commercial sector/Industry
Name [1] 257273 0
Dairy Health and Nutrition Consortium
Address [1] 257273 0
Dairy Innovation Australia
671 Sneydes Road
Werribee, Victoria 3030
Country [1] 257273 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Pigdons Road
Waurn Ponds
Geelong
Victoria
3217
Country
Australia
Secondary sponsor category [1] 256515 0
None
Name [1] 256515 0
Address [1] 256515 0
Country [1] 256515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259297 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 259297 0
Research Services
Office of the Deputy Vice-Chancellor (Research) (Melbourne Campus)
Deakin University
221 Burwood Highway
Burwood
Victoria
3125
Ethics committee country [1] 259297 0
Australia
Date submitted for ethics approval [1] 259297 0
Approval date [1] 259297 0
22/05/2009
Ethics approval number [1] 259297 0
EC120-2008

Summary
Brief summary
The reponses of the human body to a high fat meal are largely unknown. This study aims to examine the responses of the immune system, fat cells and muscle cells to a breakfast meal containing saturated fats or polyunsaturated fats. This study will specifically investigate the saturated fat that comes fom dairy foods, including milk, butter, yoghurt and cheese. Our hypothesis is that although dairy is rich in saturated fat, many of these fats are beneficial for human health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31381 0
Address 31381 0
Country 31381 0
Phone 31381 0
Fax 31381 0
Email 31381 0
Contact person for public queries
Name 14628 0
Associate Professor David Cameron-Smith
Address 14628 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood
Victoria
3125
Country 14628 0
Australia
Phone 14628 0
+61 3 9244 6502
Fax 14628 0
+61 3 9244 6017
Email 14628 0
davidcs@deakin.edu.au
Contact person for scientific queries
Name 5556 0
Associate Professor David Cameron-Smith
Address 5556 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway
Burwood
Victoria
3125
Country 5556 0
Australia
Phone 5556 0
+61 3 9244 6502
Fax 5556 0
+61 3 9244 6017
Email 5556 0
davidcs@deakin.edu.au

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