Brain & Body Protein Powder and Sleep in Older Adults
- Conditions
- SleepCognitive functionPsychological wellnessMental Health - Studies of normal psychology, cognitive function and behaviourNeurological - Studies of the normal brain and nervous system
- Registration Number
- ACTRN12624000088549
- Lead Sponsor
- Fonterra
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective sleep quality[Leeds Sleep Evaluation Questionnaire (Quality of Sleep) On day 8 (7 days after first dose of study treatment)]
- Secondary Outcome Measures
Name Time Method