Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001549415
Ethics application status
Approved
Date submitted
4/11/2016
Date registered
10/11/2016
Date last updated
7/08/2020
Date data sharing statement initially provided
7/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of combining omega-3, vitamin D and protein with exercise on cognition in older people
Scientific title
A multi-faceted intervention to enhance cognition in older people at risk of cognitive decline: the Protein, Omega-3 aNd vitamin D Exercise Research (PONDER) study
Secondary ID [1] 290350 0
N/A
Universal Trial Number (UTN)
U1111-1188-8145
Trial acronym
Protein, Omega-3 aNd vitamin D Exercise Research (PONDER)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 300635 0
Frailty 300638 0
Age-related cognitive decline 300639 0
Condition category
Condition code
Neurological 300481 300481 0 0
Studies of the normal brain and nervous system
Mental Health 300482 300482 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 300483 300483 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take part in a community based exercise program which will be conducted in local leisure centres twice per week for 6 months. Participants will be allocated to either a 6 month multi-modal exercise program combining moderate intensity resistance training or a flexibility, stretching and agility program. The multi-modal exercise program will include 2 sets of 8 resistance exercises, with 8-12 reps completed at an intensity of at least 13/20 on the BORG RPE scale. All exercise sessions will be delivered by qualified personal trainers and each session will last approximately 60 minutes. Participants will also consume a daily supplement drink containing 1.5 grams combined EPA and DHA omega 3 fatty acids, 1000 IU vitamin D3 and 25 grams whey protein for 6 months or a placebo drink. The supplement will be provided in powder form to be mixed with water. Outcomes will be assessed 6 months post-baseline after the exercise program has been completed and at 12 months post baseline to assess the longer term effects of the intervention. Adherence to the exercise programs will be monitored by the personal trainers and recorded on the participants exercise cards. Participants will record supplement intake on calendars which will be reviewed monthly.
Intervention code [1] 296166 0
Lifestyle
Intervention code [2] 296333 0
Prevention
Comparator / control treatment
A placebo drink will be matched for appearance and caloric content.
Control group
Active

Outcomes
Primary outcome [1] 299912 0
Cognitive function assessed using the CogState battery and the Trail Making Test
Timepoint [1] 299912 0
baseline, 6 months
Secondary outcome [1] 328501 0
Cognitive function assessed using the CogState battery, the Trail Making Test and the Montreal Cognitive Assessment (MoCA)
Timepoint [1] 328501 0
baseline, 12 months
Secondary outcome [2] 328503 0
Mood as assessed by the Depression, Anxiety and Stress Scale (DASS)
Timepoint [2] 328503 0
baseline, 6 and 12 months
Secondary outcome [3] 328504 0
Quality of life as assessed by the Short Form Health Survey (SF-36)
Timepoint [3] 328504 0
baseline, 6 and 12 months
Secondary outcome [4] 328505 0
Physical function as assessed by maximal muscle testing, the four metre walk test, the four square step test, the two minute step test, the grip strength test and 30 second site to stand test
Timepoint [4] 328505 0
baseline, 6 and 12 months
Secondary outcome [5] 328506 0
Body composition as assessed by whole body dual energy X-ray absorptiometry (DXA)
Timepoint [5] 328506 0
baseline, 6 and 12 months
Secondary outcome [6] 328507 0
Red blood cell omega 3 profile
Timepoint [6] 328507 0
baseline, 6 and 12 months
Secondary outcome [7] 328508 0
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index
Timepoint [7] 328508 0
baseline, 6 and 12 months
Secondary outcome [8] 328509 0
Blood pressure
Timepoint [8] 328509 0
baseline, 6 and 12 months
Secondary outcome [9] 329037 0
Serum Vitamin D
Timepoint [9] 329037 0
baseline, 6 and 12 months
Secondary outcome [10] 329039 0
Hip to waist ratio
Timepoint [10] 329039 0
baseline, 6 months and 12 months
Secondary outcome [11] 329040 0
Pulse wave veolcity
Timepoint [11] 329040 0
baseline, 6 months and 12 months
Secondary outcome [12] 329141 0
Areal bone mineral density as assessed by dual energy X-ray absorptiometry (DXA)
Timepoint [12] 329141 0
baseline, 6 months and 12 months

Eligibility
Key inclusion criteria
1. Healthy adults aged 60 to 85
2. Subjective memory complaints defined as a positive response to the question “do you feel like your memory is becoming worse?” and a score of >17 on the Montreal Cognitive Assessment.
3. Fluent in written and spoken English
4. Normal, or corrected to normal vision and hearing
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diagnosis of Alzheimer’s disease or other dementia, parkinson’s disease
2 .Past history of brain damage including significant head trauma, stroke, or
serious neurological disorder
3. Clinical diagnosis of psychiatric disorder likely to affect cognition
4. Alcohol or drug dependency within the last 2 years
5. Existing diagnosed gastrointestinal disorders likely to impact absorption of fatty acids
6. Known allergy to fish or any other component in the dietary supplement
7. Insufficient mobility to exercise
8. Body mass index >40
9. Current smokers
10. Participating in progressive resistance training >1 week or more >150 minutes per week of moderate intensity physical activity
11. Daily use of omega-3 rich supplement, or vitamin D supplements >500 IU within the past 12 weeks
12. Use of cholinesterase inhibitors, benzodiazepines, antipsychotics, high dose antidepressants, warfarin or high dose blood thinners
13. Resistance hypertension
14. Type 2 diabetes
15. Oily fish consumption (>1/week)

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)
An independent holder of the randomisation schedule who will have no contact with the volunteers or be involved in data analysis, will perform treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated simple randomization, stratified for age and gender
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
4/04/2017
Date of last participant enrolment
Anticipated
Actual
15/06/2018
Date of last data collection
Anticipated
1/10/2020
Actual
Sample size
Target
148
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294731 0
Government body
Name [1] 294731 0
NHMRC
Country [1] 294731 0
Australia
Funding source category [2] 294733 0
Government body
Name [2] 294733 0
ARC
Country [2] 294733 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Institute for Physical Activity and Nutrition Research
221 Burwood Hwy
Victoria 3125
Country
Australia
Secondary sponsor category [1] 293579 0
None
Name [1] 293579 0
Address [1] 293579 0
Country [1] 293579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296150 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 296150 0
Ethics committee country [1] 296150 0
Australia
Date submitted for ethics approval [1] 296150 0
08/08/2016
Approval date [1] 296150 0
11/10/2016
Ethics approval number [1] 296150 0
2016-260

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

Contacts
Principal investigator
Name 69766 0
Dr Helen Macpherson
Address 69766 0
Institute for Physical Activity and Nutrition
Deakin University
221 Burwood Hwy
Burwood
Vic 3125
Country 69766 0
Australia
Phone 69766 0
+61 3 9244 5317
Fax 69766 0
Email 69766 0
[email protected]
Contact person for public queries
Name 69767 0
Sarah Brownell
Address 69767 0
Institute for Physical Activity and Nutrition
Deakin University
221 Burwood Hwy
Burwood
Vic 3125
Country 69767 0
Australia
Phone 69767 0
+61 3 9246 8660
Fax 69767 0
Email 69767 0
[email protected]
Contact person for scientific queries
Name 69768 0
Helen Macpherson
Address 69768 0
Institute for Physical Activity and Nutrition
Deakin University
221 Burwood Hwy
Burwood
Vic 3125
Country 69768 0
Australia
Phone 69768 0
+61 3 9244 5317
Fax 69768 0
Email 69768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseMultifaceted intervention to enhance cognition in older people at risk of cognitive decline: Study protocol for the Protein Omega-3 and Vitamin D Exercise Research (PONDER) study.2019https://dx.doi.org/10.1136/bmjopen-2018-024145
EmbaseOmega-3 Long-Chain Polyunsaturated Fatty Acids: Are They Beneficial for Physical and Cognitive Functioning in Older Adults?.2021https://dx.doi.org/10.1007/s12603-020-1553-7
N.B. These documents automatically identified may not have been verified by the study sponsor.