None listed
Conditions
Brief summary
The aim of the present study is to investigate the effects of Brain and Body protein powder on sleep quality and other health-related outcomes—including cognition, mood, brain activity and biochemical parameters— in ageing adults 55-to-75 years of age. The Brain and Body protein powder may have the potential to affect benefits in the outcomes noted. This will be an 8-day randomised, double-blind placebo-controlled trial where 40 participants will be recruited. The trial will consist of two arms: 1) Dairy-based protein powder (Brain & Body Protein Powder) and 2) Rice starch placebo control.
Interventions
Arm 1:
Brain & Body Protein Powder
Participants will be required to consume 1 x 30g serve of Brain & Body Protein Powder per day. Each serve is to be mixed with around 200ml water and consumed 90 minutes prior to bedtime. Participants consume the intervention daily for 7 days.
Compliance will be monitored throughout the study. Participants will be assisted with this process through the completion of a consumption calendar that requires them to mark off each serving at time of its consumption.
Arm 1: Brain & Body Protein Powder Participants will be required to consume 1 x 30g serve of Brain & Body Protein Powder per day. Each serve is to be mixed with around 200ml water and consumed 90 minutes prior to bedtime. Participants consume the intervention daily for 7 days. Compliance will be monitored throughout the study. Participants will be assisted with this process through the completion of a consumption calendar that requires them to mark off each serving at time of its consumption. Participants who consume less than 80% of the required product throughout the duration of the study (equal to more than 1 missed serve) will be excluded from final analysis.
Sponsors
Fonterra
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 55 to 64 years of age (inclusive) at phone screen 2. Self-reported answer of yes to the following: “Do you feel as though you have poor sleep quality?” 3. BMI equal to or more than 18.5 or equal to or less than 35 at time of phone screen 4. Willing and able to provide informed consent 5. Access to a personal (i.e., not shared) and valid email address
Exclusion criteria
1. Previous adverse reaction to milk or dairy proteins 2. Known allergy to rice, soy or soy lecithin 3. Current or recent participation, within the last 6 months, in any other clinical trial involving the administration of an active intervention for any purpose. 4. Current or previous sleep disorder diagnosis (e.g., sleep apnoea, insomnia) 5. Undiagnosed sleep apnoea (positive score in 2 or more categories of the Berlin Questionnaire) 6. Currently undergoing treatment to improve sleep (including psychotherapy and/or medication, e.g., Restavit, melatonin) 7. Currently engaged in ongoing shift work (i.e., any shift work undertaken in the last month) 8. Recent (approximately 2 weeks) travel across time zones/jetlag 9. Score of equal to or less than 11 on the MoCA-5min 10. Self-reported history of events that impact cognitive function defined as: concussion or brain injury requiring hospitalisation, transient ischemic attacks (mini-stroke), stroke, heart attack, coronary artery bypass surgery, or open-heart surgery. 11. Known history of Intellectual Disability or other developmental disorder (e.g., language disorder, ADHD, Autism) 12. A mental health condition that is being actively treated either pharmacologically or by a licensed mental-health professional (e.g., major depressive disorder, PTSD) 13. Diagnosed neurological disease including dementia (any type), Parkinsons Disease, Amyotrophic Lateral Sclerosis, Motor-neuron Disease, hippocampal damage, or Huntingtons Disease 14. Known type 1 or 2 Diabetes 15. Known digestive disorder diagnosis (e.g., GERD, IBS) 16. Blood pressure systolic more than 160 mmHg and diastolic more than 100 mmHg 17. Recent (i.e., in the last 3 months) medication use related to or likely to affect sleep, cognition, mood or serotonin levels, or medication which is not recommended to be used with tryptophan 18. Current smoker/vaper (or history of smoking including within last 12 months) 19. Recent (~6-month) use of illicit or psychoactive drugs 20. Individuals living with children under 12 months of age 21. Needle phobia or fainting due to fear of needles 22. Alcohol consumption more than 7 standard drinks per week 23. Known eosinophilia or liver/kidney diseases 24. Known carcinoid syndrome
Outcome results
None listed