Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000021875
Ethics application status
Approved
Date submitted
4/01/2012
Date registered
5/01/2012
Date last updated
4/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of dairy-based high-protein, variable-carbohydrate diets and exercise on muscle maintenance and movement
Scientific title
In overweight sedentary adults, is a high protein, dairy based calorie restricted diet combined with exercise, compared with high carbohydrate, adequate protein calorie restricted diet combined with exercise, more effective in maintaining skeletal muscle mass during weight loss
Secondary ID [1] 279663 0
Nil
Universal Trial Number (UTN)
U1111-1126-7965
Trial acronym
DAIRY-FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 285476 0
Sarcopenia 285477 0
Condition category
Condition code
Diet and Nutrition 285657 285657 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Modification of diet into two groups:
G1 = High dairy, high protein moderate carbohydrate (CHO) diet
G2 = High dairy, high protein, high CHO diet
Both groups will have their diet modified for a period of 16 weeks by a qualified dietitian. Group 1's (G1) diet will consist of foods that will make up 40% energy needs from Carbohydrates, 30% energy needs from Protein sources and 30% energy needs from Fat sources and will be individualised for each subject. Group 2's (G2) diet will consist of foods that will make up 55% of energy needs from Carbohydrates, 30% energy needs from Protein sources and 15% energy needs from Fat sources and will be individualised for each subject.
During the 16 week dietary modification period, participants will complete 3 supervised and 3 unsupervised exercise sessions per week for the entire duration. The supervised exercise sessions will take place at RMIT University Bundoora by CERT3/4 qualified fitness instructors or equivalent.
The diets will not be provided to participants but the dietitian will work with each individual to ensure they achieve the required energy ratios. There are no set number of meals, again this is based on the individual.
Intervention code [1] 283944 0
Treatment: Other
Intervention code [2] 283945 0
Prevention
Intervention code [3] 283946 0
Lifestyle
Comparator / control treatment
The comparator group (G3) will undertake a “healthy” diet (high CHO, adequate protein) for 16 weeks and complete the same exercise regime as G1 and G2. The healthy diet will consist of 55% energy needs from Carbohydrates, 30% energy needs from Fat sources and 15% energy needs from Protein sources.
Control group
Active

Outcomes
Primary outcome [1] 286207 0
Change in body composition: lean mass (kg) and fat mass (kg) as measured by Dual-energy X-ray absorptiometry (DXA) and anthropometric measures
Timepoint [1] 286207 0
Measured at baseline and at 8 and 16 weeks after intervention commencement
Secondary outcome [1] 295390 0
Strength and Cardio-respiratory fitness.
Strength will be assessed using four common resistance exercises (seated leg extension, hamstring curls, seated row and chest-press) through 1 repetition maximum (1RM) tests. Cardio-respiratory fitness will be measured through a VO2 max test where a facemask and heart rate monitor are worn throughout an increasing intensity test to fatigue.
Timepoint [1] 295390 0
Measured at baseline and at 8 and 16 weeks after intervention commencement
Secondary outcome [2] 295391 0
Blood profile (lipids; glucose and insulin (HOMA index)
Timepoint [2] 295391 0
Measured at baseline and at 8 and 16 weeks after intervention commencement
Secondary outcome [3] 295392 0
Daily energy expenditure will be measured using Sensewear armbands which measures motion, accelerometry, galvanic skin response, skin temperature and heat flux to give a measure of energy expenditure over several days
Timepoint [3] 295392 0
Measured at baseline and at 8 and 16 weeks after intervention commencement

Eligibility
Key inclusion criteria
Body Mass Index (BMI) between 27-40 kg/m2 i.e. classified as overweight, class I Obese or class II Obese; Sedentary
Minimum age
35 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Metabolic risk factors (hypercholesterolemia, hyperinsulinemia, and hyperglycemia, hypertenisive), heart and other organ disease, orthopaedic injury, gastrointestinal disease, clinically diagnosed dairy protein allergy, clinically diagnosed lactose intolerance.

Study design
Purpose of the study
Treatment
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)
The randomization will be initially stratified by baseline BMI values (27–29, 30–34, and 35–40 kg/m2) and sex. Subsequently, simple randomisation by roll of dice within the stratified segregation will be used to allocate individuals to each of the 3 groups. This will ensure that an equal number of subjects from each category of BMI will be allocated to a dietary intervention group.
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
1/03/2012
Actual
12/03/2012
Date of last participant enrolment
Anticipated
Actual
3/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 4845 0
3083

Funding & Sponsors
Funding source category [1] 284444 0
Commercial sector/Industry
Name [1] 284444 0
Dairy Health & Nutrition Consortium
Country [1] 284444 0
Australia
Primary sponsor type
Individual
Name
Professor John Hawley
Address
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 283366 0
Individual
Name [1] 283366 0
Professor Louise Burke
Address [1] 283366 0
Department of Sports Nutrition
Australian Institute of Sport
PO Box 176
BELCONNEN
ACT 2616
Country [1] 283366 0
Australia
Other collaborator category [1] 260415 0
Individual
Name [1] 260415 0
Dr Vernon Coffey
Address [1] 260415 0
Exercise Metabolism Group
School of Medical Sciences
Building 223.2.51
RMIT University
PO Box 71
Bundoora
Victoria 3083
Country [1] 260415 0
Australia
Other collaborator category [2] 260416 0
Individual
Name [2] 260416 0
Ms Evelyn Parr
Address [2] 260416 0
Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne VIC 3000
Country [2] 260416 0
Australia
Other collaborator category [3] 260417 0
Individual
Name [3] 260417 0
Professor Stuart Phillips
Address [3] 260417 0
Ivor Wynne Centre, Room E210
Department of Kinesiology
McMaster University
1280 Main Street West
Hamilton, ON L8S 4K1
Country [3] 260417 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286421 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 286421 0
Ethics committee country [1] 286421 0
Australia
Date submitted for ethics approval [1] 286421 0
15/12/2011
Approval date [1] 286421 0
20/01/2012
Ethics approval number [1] 286421 0
76/11

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

Contacts
Principal investigator
Name 33579 0
Prof John Hawley
Address 33579 0
Centre for Exercise and Nutrition, Mary MacKillop Institute for Health Research, Australian Catholic University, Level 5, 215 Spring Street, Melbourne VIC 3000
Country 33579 0
Australia
Phone 33579 0
+61 3 9953 3552
Fax 33579 0
Email 33579 0
[email protected]
Contact person for public queries
Name 16826 0
John Hawley
Address 16826 0
Centre for Exercise and Nutrition, Mary MacKillop Institute for Health Research, Australian Catholic University, Level 5, 215 Spring Street, Melbourne VIC 3000
Country 16826 0
Australia
Phone 16826 0
+61 3 9953 3552
Fax 16826 0
+61-3-9467 8181
Email 16826 0
[email protected]
Contact person for scientific queries
Name 7754 0
John Hawley
Address 7754 0
Centre for Exercise and Nutrition, Mary MacKillop Institute for Health Research, Australian Catholic University, Level 5, 215 Spring Street, Melbourne VIC 3000
Country 7754 0
Australia
Phone 7754 0
+61 3 9953 3552
Fax 7754 0
+61-3-9467 8181
Email 7754 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
EmbaseCirculating microrna responses between 'high' and 'low' responders to a 16-Wk diet and exercise weight loss intervention.2016https://dx.doi.org/10.1371/journal.pone.0152545
N.B. These documents automatically identified may not have been verified by the study sponsor.