None listed
Conditions
Brief summary
This research project is aiming to determine the effects of 3 months supplementation with a proprietary spearmint extract, on cognitive functioning in healthy individuals. Participants will be required to complete 4 testing sessions and 1 screening session. During these sessions they will be asked to complete a variety of measures assessing cognitive function and general health. Participants will be asked to take one of the following treatments for a 90 day period: - Proprietary spearmint extract - Matched placebo
Interventions
This study is a randomised, double-blind, placebo-controlled, parallel intervention trial. A total of 128 individuals aged 50 to 70 years will take part in the study with an intervention period of 90 days.
Participants will be required to complete four testing sessions (day 0, day 7, day 30 and day 90), and one screening session. At each session participants will be required to complete a series of measures assessing cognitive function.
Following visit 1 participants will be randomly allo
This study is a randomised, double-blind, placebo-controlled, parallel intervention trial. A total of 128 individuals aged 50 to 70 years will take part in the study with an intervention period of 90 days. Participants will be required to complete four testing sessions (day 0, day 7, day 30 and day 90), and one screening session. At each session participants will be required to complete a series of measures assessing cognitive function. Following visit 1 participants will be randomly allocated to receive one of the two treatments (administered in capsules) - Proprietary spearmint extract (900 mg/day) - Matched placebo (of microcrystalline cellulose) The study product (two capsules) will be administered orally (self-administered at home) daily for 90 days. Compliance will be assessed by capsule count at each study visit.
Sponsors
Centre for Human Psychopharmacology, Swinburne University.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
People who meet the following inclusion criteria will be included in the trial: - Male or female, aged 50 to 70 years, inclusive. - Willing and able to provide written informed consent. - Understands and is willing and able to comply with all study procedures. - Fluent in written and spoken English. - Are in good general health as judged by the Investigator on the basis of medical history and biochemical assessment.
Exclusion criteria
Participants who display any of the following will be excluded from the trial: - Participant is unable to understand and/or perform required tests according to the practice test results. - Participant has a history of repeated minor head injury (e.g., in boxing) or a single injury resulting in a period of unconsciousness for 1 h or more. - Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer. - Subject has an active infection or signs/symptoms of an infection at clinic visit. Clinic visits will be rescheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days. - Subject has recently used antibiotics (within 5 days of any clinic visit). - Currently participating in or has participated in any other study involving an investigational product in the last 4 weeks.
Outcome results
None listed