Can a proprietary spearmint extract improve cognitive function?

Category Primary study
Registry of TrialsANZCTR
Year 2015
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. 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. Cognitive function as assessed by the COMPASS cognitive assessment battery. The assessment battery includes tasks that assess attention, working memory, episodic memory and executive function domains. Measures of general health as assessed by the following questionnaires: ‐ Profile of Mood States (POMS) ‐ Leeds Sleep Evaluation Questionnaire (LSEQ) ‐ Everyday Memory Questionnaire (EMQ) ‐ Quality of Life Index (QLI) ;Biomarkers of oxidative stress as assessed by serum analysis.
Epistemonikos ID: 184cfaf3ff5509780635fae974590436fbcb9658
First added on: Aug 21, 2024