None listed
Conditions
Brief summary
The Protein, Omega-3 aNd vitamin D Exercise Research (PONDER) study is a randomised controlled trial which will investigate the effects of combining a structured exercise program with dietary supplements on cognition and muscle mass and function in people aged 60 -85 years. The PONDER study is being run by researchers from the Institute of Physical Activity and Nutrition (IPAN) at Deakin University in Burwood. People who take part in this research will be assigned to one of two exercise programs run in a community based gym. Participants will either receive a dietary supplement drink which contains a combination of protein, omega 3 fish oil and vitamin D, or a placebo. The exercise programs will be run for 6 months in community based gyms under the supervision of qualified trainers. Participants will be asked to attend Deakin University in Burwood on 4 occasions over 12 months to undergo cognitive and health testing and to visit a local pathology centre on 3 occasions for a blood test. Participants in this study will attend 2 x 60 min supervised exercise sessions per week at a local gym, for a period of six months and will be asked to consume a dietary supplement daily during this time.
Interventions
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 se
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Healthy volunteers
Yes
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
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)
Outcome results
None listed