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

Anxiety Clinical Trial

— Yaaddasht  

Official title:

Chronic Effect of Brahmi on Cognition Performance and Anxiety in Healthy Indian Adults and Exploration of Pharmacokinetic Properties of Brahmi Components in Healthy Adult Males.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462642
• Other study ID #: 08068B
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: June 1, 2015
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: June 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The Indian Ayurvedic herb Brahmi (Bacopa monniera) has been used to improve cognitive functions in Indian sub-continent for many years and previous intervention studies have shown positive effects of Brahmi on cognitive performance in adults. However, the studies are conducted on various fractions and extracts and there is high likelihood of variability of composition amongst the fractions/extracts tested in these studies. Furthermore, although the findings of the previous studies overlap to some extent, they are not consistent and there is a need to replicate these findings.

Further, even though Brahmi has been studied for its chemical composition and its therapeutic benefits as a whole, there are still severe gaps with respect to the complete composition of the Brahmi plant or its extracts. No published data exist on the Pharmacokinetics (PK) properties of Brahmi components. Hitherto, the evidence and the mechanistic details are still speculative and the biological activity is still phenomenological. Because of this severe knowledge gap, this study will try to repeat the findings on cognitive performance and at the same time also explore the plasma levels of its components in order to initiate the understanding of ADME aspects and its linkages to the biological effect.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cognition
• Pharmacokinetics

Intervention

Dietary Supplement:
• Brahmi
Brahmi extract - 225 mg filled in each hard gelatin capsule. Two such capsules per day, to be taken by the subjects for 12 weeks.

Other:
• Placebo
Dry maize starch filled in identical hear gelatin capsule. Two such capsules will be taken by each subject per day for 12 weeks.

Dietary Supplement:
• Brahmi
Brahmi Extract 225 mg filled in hard gelatin capsule. Two such capsules will be consumed by the subjects each day for 84 days.

Other:
• Placebo
Placebo capsules - Dry starch filled in identical hard gelatin capsules

Locations

Country	Name	City	State
India	St Johns Research Institute	Bangalore	Karnataka

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	St. John's Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Delayed recall from Baseline at day 0 to post intervention at day 84	Rey Auditory Verbal Learning Test, Delayed recall	"0" (baseline) day and "84" day (Post Intervention)	No
Secondary	Total learning, change between baseline at day 0 to post intervention at day 84	Rey Auditory Verbal Learning Test, total learning,	"0" day and "84" day	No
Secondary	Pro-active interference, change between baseline at day 0 to post intervention at day 84	Rey Auditory Verbal Learning Test, pro-active interference	"0" day and "84" day	No
Secondary	Retro-active interference, change between baseline at day 0 to post intervention at day 84	Rey Auditory Verbal Learning Test, retro-active interference	"0" day and "84" day	No
Secondary	Inspection Time, change between baseline at day 0 to post intervention at day 84	Inspection Time Task: Inspection Time	"0" day and "84" day	No
Secondary	Reaction time, correct responses, change between baseline at day 0 to post intervention at day 84	Rapid Visual Information Processing Test, reaction time, correct responses	"0" day and "84" day	No
Secondary	Reaction time, errors, change between baseline at day 0 to post intervention at day 84	Rapid Visual Information Processing Test, reaction time, errors	"0" day and "84" day	No
Secondary	Interference, change between baseline at day 0 to post intervention at day 84	Stroop Task, Interference	"0" day and "84" day	No
Secondary	State, change between baseline at day 0 to post intervention at day 84	State-trait Anxiety Inventory, state	"0" day and "84" day	No
Secondary	Trait, change between baseline at day 0 to post intervention at day 84	State-trait Anxiety Inventory, trait	"0" day and "84" day	No
Secondary	Absorption constant	Constant of absorption of the Brahmi components	"0" day and "84" day	No
Secondary	Tmax	Time of highest concentration in blood of the Brahmi components	"0" day and "84" day	No
Secondary	T1/2	Half-life of the of the Brahmi components	"0" day and "84" day	No
Secondary	Metabolites	Scan for potential metabolites of the Brahmi components	"0" day and "84" day	No