Effect of Bacopa Monniera Extract on Cognition and Anxiety and Exploration of PK Properties

The study is proposed to be a randomised, double blind, placebo-controlled study with parallel groups. The duration of the study will be 12 weeks.

For cognition and Anxiety part, each selected subject will be paying 4 visits to clinical site for the whole study. Screening/selection will be done on visit 1, baseline on visit 2 and post-intervention assessment on visit 3. Subjects will be asked to appear for an interview before the investigators once more within one month of completion of intervention to take care of issues, if any. This will be 4th and last visit.

Each subject will be assessed at baseline (Week 1, Day 1); while post intervention assessment will be carried out immediately on the completion of the 12 weeks. Considering the 84 days duration of the study, + 3 days for the intervention period will be acceptable. The exact intervention duration will be documented in days for each subject.

On each of the two measurement days (baseline and post intervention), the same test battery will be administered by the same examiner. The outcome measures of this battery include Verbal Learning and Memory, Information Processing, Attention and Interference and Anxiety. The test battery will be administered in English.

On each of the measurement day the subject will spend a maximum of 1½ hours at the clinical site. Subjects will be examined in the morning at approximately the same time during both measurement days to keep conditions constant across the subjects and for baseline and post intervention assessments.

Each subject participating in Pharmacokinetics (PK) part, will pay 6 visits. Visit 1 will be screening, Visit 2,3 and 4 for initial blood withdrawal and visit 5 will post intervention blood sampling. Subjects will be asked to appear for an interview before the investigators once more within one month of completion of intervention to take care of issues, if any, which will be visit 6.

Blood sampling will be done at 0,1,2,4,8,24,48 hours and one sample at the endo of 12 weeks intervention.

Inclusion criteria

• Male and female subjects in the age between 35 and 60 at start of the study
• BMI BETWEEN 20 and 30 kg/m2
• Apparently mentally and physically healthy
• Willing to refrain from foods and supplements that contain caffeine, such as coffee, tea, chocolate, cola and energy drinks from 9 PM on the evening before each test day.
• Willing to refrain from supplements that are likely to have an effect on cognitive performance
• Having Haemoglobin counts more than 11 mg/ DL and normal blood profile in Physician's opinion (only for pharmacokinetic part)

Exclusion criteria

• Being on a medically prescribed- or slimming diet
• Reported weight loss/gain > 10% of body weight in the 6 month preceding pre-study examination
• Using herbal supplements or dietary supplements meant for improving cognitive performance
• Undergoing medical treatment that may interfere with the study outcome
• Using systemic antibiotics in the period of 3 months prior to or during the run-in period of the study
• Scoring above the cut off 9 on the GHQ28
• Pregnancy during the study period or in the six months prior to pre-study investigation
• Reported lactating 6 weeks before pre-study investigation and during the study
• Intense exercise >10 h/w
• Being colour-blind or dyslexic
• Hearing or vision impairments
• High alcohol consumption as indicated by a score of 4 or more on the AUDIT-C
• Smoking and/ or chewing tobacco during the past 6 months
• Recreational drug use during the past 6 months