None listed
Conditions
Brief summary
This study aims to assess the effects of creatine monohydrate (CrM) supplementation on cognitive function in New Zealand's older adult population with mild cognitive function impairment (MCFI) age-related, non-clinical. The objective is to estimate the effect size and potential clinical utility of CrM supplementation on performance in cognitive domains, including memory, executive function, and attention. We hypothesise that taking this amount for creatine monohydrate for shorter duration will improve cognitive function in the older adults. The study will be a randomised, double-blind, placebo-controlled, baseline and post-test crossover design. Eighteen older adults, aged >60 years, with mild cognitive impairment, will be recruited from the local Auckland community, retirement villages, and regular health check-up facilities through promotional advertisements and activities. The initial screening will be done at the local facility, Nutrition & Dietetics Lab, based at the IC building, Massey University, Auckland Campus. Following an initial screening period (comprising the complete assessment of health parameters and cognitive functions), participants will be randomised into CrM (intervention; 20 g/day dose of CrM) or placebo (PLA; maltodextrin) groups. Each group will consume the supplement at 2 x 10 g /day for 7 days before undertaking a 35-day washout period, followed by the second study period. The total study duration will be 52 days, including 5 weeks of washout. A battery of three cognitive function tests will be performed pre-supplementation and post-supplementation. Mini Mental State Examination (MMSE) for general cognitive function (orientation, memory, attention, language, and visuospatial abilities), Montreal Cognitive Assessment (MoCA) for attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation, and Raven's Advanced Progressive Matrices (RAPM) for abstract reasoning and pattern recognition estimate fluid intelligence that does not rely on verbal ability.
Interventions
Creatine monohydrate (CrM) will be the Intervention. The CrM as the intervention involves the administration of 2 x 10 g / day (total 20 g /day) of CrM for 7 days. The total daily dose will be divided into two equal doses, with 10 g taken in the morning and 10 g in the afternoon, both dissolved in 250 mL of water with artificial flavour and sweetener.
Adherence Monitoring Strategies (Brief Description)
Adherence to the intervention will be monitored by asking participants to return unused study
Creatine monohydrate (CrM) will be the Intervention. The CrM as the intervention involves the administration of 2 x 10 g / day (total 20 g /day) of CrM for 7 days. The total daily dose will be divided into two equal doses, with 10 g taken in the morning and 10 g in the afternoon, both dissolved in 250 mL of water with artificial flavour and sweetener. Adherence Monitoring Strategies (Brief Description) Adherence to the intervention will be monitored by asking participants to return unused study product at each visit, maintaining a simple daily intake log, and completing brief check-ins with study staff to confirm compliance. Returned supplement counts will be used to estimate adherence. Cross-Over Design and Washout Period This study uses a cross-over design, in which each participant receives both the creatine intervention and the placebo control in different periods. A washout period of [5 weeks] will occur between treatment phases to minimise carry-over effects and to ensure that any residual impact of the first treatment has dissipated before starting the second phase.
Sponsors
Professor David S Rowlands (College of Health, Massey University, Auckland).
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Older adults aged 60 years and over with mild cognitive function impairment (MCFI) using the MoCA scale. Who pass a general health questionnaire and provide written consent, may volunteer for the study.
Exclusion criteria
• Don’t meet the health requirements defined in the health questionnaire. • Having known dementia or a neurodegenerative disease, e.g., Alzheimer’s, Parkinson's, or conditions that may alter cognitive function /memory loss or interfere with the test supplement. • Taking medications thought to interfere with the study outcomes. • Currently participating or having participated in another clinical study during the last four weeks before the beginning of this study that may affect the results of the current study. • Habitual creatine monohydrate user or planning on starting supplementation during the study. • Recent change in high dietary creatine-containing food (e.g., meat, fish) intake or plan to change dietary pattern during participation in the study. • Unable to meet study requirements, having known dementia or any other clinical brain condition.
Outcome results
None listed