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Trial registered on ANZCTR


Registration number
ACTRN12611000248965
Ethics application status
Approved
Date submitted
7/03/2011
Date registered
7/03/2011
Date last updated
2/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of lutein with milk on physical activity
Scientific title
Efficacy of lutein-milk for improving exercise self-efficacy and exercise participation in older adults
Secondary ID [1] 259732 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 261311 0
Condition category
Condition code
Diet and Nutrition 259461 259461 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be encouraged to undertake regular physical activity involving the performance of at least 150 min/week of moderate to vigorous activity in accordance with the national physical activity guidelines for Australian adults for 3 weeks (Week 1-4). The physical activity will be left up to the participant to perform.
In addition to undertaking regular physical activity, participants will be allocated to the treatment group (capsules containing 21 mg/day of lutein) or the placebo group. Participants will be required to consume a capsule and 250 ml of full cream milk at the same time everyday, preferably in the morning, for 4 weeks (Week 0-4).
Intervention code [1] 264165 0
Treatment: Other
Comparator / control treatment
placebo capsules contain 155 mg of microcrystalline cellulose and 155 mg of lactose
Control group
Placebo

Outcomes
Primary outcome [1] 262275 0
Physical activity levels (measured using accelerometry)
Timepoint [1] 262275 0
An accelerometer will be worn the week prior to beginning supplementation (Week -1) and again after 4 weeks of supplementation (Week 4).
Secondary outcome [1] 273438 0
Physical activity levels (step counts from pedometer)
Timepoint [1] 273438 0
Pedometers will be worn for the entire 5 week study period and daily step counts will be recorded
Secondary outcome [2] 273439 0
Self-efficacy to regulate exercise will be assessed using a validated questionnaire portraying different levels of exercise task demands against which participants rate the strength of their belief in their ability to perform their exercise routine regularly using a 100 point scale. The higher the total score the greater the exercise-self efficacy.
Timepoint [2] 273439 0
Exercise self-efficacy will be assessed at the start of Week -1 and again a week later before supplementation begins (week 0) and then again after one week of supplementation (Week 1) and again at the end of the study period (Week 4)
Secondary outcome [3] 273440 0
Blood concentration of lutein
Timepoint [3] 273440 0
fasting blood samples will be taken at baseline (Week -1) and at the end of the study period (Week 4)

Eligibility
Key inclusion criteria
Aged between 60 and 80 yrs Not currently participating in sufficient physical activity levels to meet Australia guidelines BMI between 18.5 and 29.9 kg/m2
Minimum age
60 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Typically consume more than two standard serves of dairy products per day
Non weight-stable (body weight change of >3 kg in last 3 months)
Acute or terminal illness
Moderate or severe cognitive impairment (inability to understand and provide written informed consent and/or follow instructions)
Any medical condition that might be exacerbated by exercise or might limit exercise training
Current smoker or only recently quit smoking (smoked any cigarettes within the last 12 months)
Alcohol consumption (more than four alcoholic drinks per day)
Coeliac disease
Lactose intolerance
Allergy to cow’s milk protein
Diabetes
Medications (or supplements) changed significantly during the last 12 weeks
Consume carotenoids (lutein, astaxanthin, zeaxanthin) supplements daily
Any other condition which in the opinion of the investigators might confound the outcomes of the study

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)
Subjects will be recruited by newspaper advertisement and flyers. Volunteers will be screened via questionnaire and a medical screening visit to access their eligibility for the trial. Eligibility will be determined by the study coordinator and medical physician. Treatment will be randomised by an investigator not involved in data collection and allocation will be concealed from the participant and study staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to treatments will be via the process of minimisation (1) on the basis of gender, age, and current levels of physical activity (assessed by pedometry in the week prior to treatment allocation).
Masking / blinding
Blinded (masking 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
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] 264612 0
Commercial sector/Industry
Name [1] 264612 0
Meiji Dairies Corporation
Address [1] 264612 0
540 Naruda, Odawara, Kanagawa 250-0862
Country [1] 264612 0
Japan
Primary sponsor type
Commercial sector/Industry
Name
Meiji Dairies Corporation
Address
540 Naruda, Odawara, Kanagawa 250-0862
Country
Japan
Secondary sponsor category [1] 263750 0
None
Name [1] 263750 0
Address [1] 263750 0
Country [1] 263750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260614 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 260614 0
General Purpose Building, Mawson Lakes Campus Mawson Lakes Boulevard Mawson Lakes, SA 5095
Ethics committee country [1] 260614 0
Australia
Date submitted for ethics approval [1] 260614 0
Approval date [1] 260614 0
21/02/2011
Ethics approval number [1] 260614 0
21020

Summary
Brief summary
The aim of this study is to determine whether the consumption of lutein with milk increases exercise-self efficacy, leading to increased exercise participation in older adults. The overall purpose is to provide scientific substantiation for a novel nutritional supplement aimed at increasing physical activity to improve health and reduce disability in an ageing population.

Preliminary research in rats demonstrated that the consumption of lutein-fortified milk increased the duration of voluntary wheel running. This increased wheel running was associated with enhanced muscle development and reduced body fat. The mechanism by which the lutein-fortified milk stimulated the rats to increase the volume of wheel running is not known, but it seems likely that there was some change in their mood which promoted exercise behaviour. If this supplement were to elicit a similar effect in people being encouraged to undertake regular physical activity this might result in them undertaking a greater volume of exercise and thus potentially achieving health benefits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32303 0
Address 32303 0
Country 32303 0
Phone 32303 0
Fax 32303 0
Email 32303 0
Contact person for public queries
Name 15550 0
Dr Rebecca Thomson
Address 15550 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 15550 0
Australia
Phone 15550 0
+61 8 8302 1822
Fax 15550 0
Email 15550 0
rebecca.thomson@unisa.edu.au
Contact person for scientific queries
Name 6478 0
Associate Professor Jon Buckley
Address 6478 0
Nutritional Physiology Research Centre
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 6478 0
Australia
Phone 6478 0
+61 8 8302 1853
Fax 6478 0
Email 6478 0
jon.buckley@unisa.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