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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]

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

Sarcopenia

Condition category

Condition code

Diet and Nutrition

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]

Treatment: Other

Intervention code [2]

Prevention

Intervention code [3]

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]

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]

Measured at baseline and at 8 and 16 weeks after intervention commencement

Secondary outcome [1]

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]

Measured at baseline and at 8 and 16 weeks after intervention commencement

Secondary outcome [2]

Blood profile (lipids; glucose and insulin (HOMA index)

Timepoint [2]

Measured at baseline and at 8 and 16 weeks after intervention commencement

Secondary outcome [3]

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]

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

Accrual to date

Final

115

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3083

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Dairy Health & Nutrition Consortium

Address [1]

Dairy Innovation Australia
671 Sneydes Road
Werribee, Victoria 3030

Country [1]

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]

Individual

Name [1]

Professor Louise Burke

Address [1]

Department of Sports Nutrition
Australian Institute of Sport
PO Box 176
BELCONNEN
ACT 2616

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr Vernon Coffey

Address [1]

Exercise Metabolism Group
School of Medical Sciences
Building 223.2.51
RMIT University
PO Box 71
Bundoora
Victoria 3083

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Ms Evelyn Parr

Address [2]

Centre for Exercise and Nutrition
Mary MacKillop Institute for Health Research
Australian Catholic University
Level 5, 215 Spring Street
Melbourne VIC 3000

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Professor Stuart Phillips

Address [3]

Ivor Wynne Centre, Room E210
Department of Kinesiology
McMaster University
1280 Main Street West
Hamilton, ON L8S 4K1

Country [3]

Canada

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RMIT Human Research Ethics Committee

Ethics committee address [1]

Research & Innovation, 
RMIT University, 
GPO Box 2476V, 
Melbourne, 3001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/12/2011

Approval date [1]

20/01/2012

Ethics approval number [1]

76/11

Summary

Brief summary

The willingness of the majority of Australians to adopt a sedentary lifestyle accompanied by an excess energy intake underpins the current epidemic of lifestyle diseases. In an effort to prevent the rise of inactivity-related conditions, medical and health professionals prescribe energy-restricted weight-loss programmes combined with increased physical activity as a means to reduce body mass (weight) and improve health outcomes. However, typical diet-induced weight loss leads to an imbalance in body composition that reduces an individuals’ functional capacity (i.e., movement and activity patterns) and increases their susceptibility to metabolic disorders. Specifically, the complex interactions between elevated levels of body fat and a reduced muscle size result in a high fat: muscle ratio, leading to a cascade of events that accelerate pre-existing health conditions (i.e., sarcopenia) and simultaneously predispose an individual to further (new) health risks. 
At present, the optimal diet to achieve weight loss and promote favourable body composition changes in overweight adults remains highly controversial. More information is needed to determine the effects of different diets on energy metabolism, energy balance and body composition. Indeed, the biggest concern for the majority of Australian adults is how to lose fat mass while preserving muscle mass and the health benefits that accrue from a nutrient-rich high-quality protein diet and physical activity. Accordingly, the aim of this project is to discover and characterise the best composition of mildly energy restricted high-protein (dairy-based), variable-carbohydrate diets consumed in association with resistance training to improve health.

Trial website

http://www.rmit.edu.au/browse;ID=6b379xz4gl2a;STATUS=A;SECTION=2;PAGE_AUTHOR=Julia%20Wong

Trial related presentations / publications

Parr, E.B., Coffey, V.G., Cato, L.E., Phillips, S.M., Burke, L.M., Hawley, J.A. A randomized trial of high-dairy-protein, variable-carbohydrate diets and exercise on body composition in adults with obesity, Obesity (Silver Spring), 2016, 24(5): 1035-45.

Public notes

Contacts

Principal investigator

Name

Prof 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

Phone

+61 3 9953 3552

Fax

john.hawley@acu.edu.au

Contact person for public queries

Name

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

Phone

+61 3 9953 3552

Fax

+61-3-9467 8181

john.hawley@acu.edu.au

Contact person for scientific queries

Name

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

Phone

+61 3 9953 3552

Fax

+61-3-9467 8181

john.hawley@acu.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	Circulating microrna responses between 'high' and 'low' responders to a 16-Wk diet and exercise weight loss intervention.	2016	https://dx.doi.org/10.1371/journal.pone.0152545

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