Last updated: 11/03/2018 22:17:09
fMRI study to investigate hemodynamic changes in brain resulting from supplementation of Bacopa Monnieri extract and multiple micronutrient supplementation.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Impact of a multiple micronutrient (MMN) fortified powder supplemented with Bacopa monnieri extract (EBM) on hemodynamic responses as measured by Functional Magnetic Resonance Imaging (fMRI) in Indian school children (11-12 yrs; inclusive) after approximately 4 months of intervention: an exploratory, randomized, double-blind, controlled trial
Trial description: The study will aim to compare the effects of a beverage powder fortified with multiple micronutrients and Bacopa monnieri extract (test product) to a non-fortified isocaloric beverage powder (control product) on cognitive outcomes of attention and working memory.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Changes in regional brain hemodynamic response during attention task, as measured by cognitive Functional Magnetic Resonance Imaging (fMRI)
Timeframe: At Baseline and week 17
Secondary outcomes:
Changes in regional brain hemodynamic response during working memory task, as measured by cognitive fMRI
Timeframe: At Baseline and week 17
Changes in functional hemodynamic response in cognitive network, as measured by resting-state fMRI
Timeframe: At Baseline and week 17
Changes in gray matter density, as measured by structural MRI
Timeframe: At Baseline and week 17
Change in Spatial Working Memory - Between Error Score
Timeframe: At Baseline and week 17
Change in Spatial Working Memory - Strategy Score
Timeframe: At Baseline and Week 17
Change in Rapid Visual Information Processing - Prime Score
Timeframe: At Baseline and week 17
Change in Rapid Visual Information Processing - Median Latency Score
Timeframe: At Baseline and week 17
Change in Rapid Visual Information Processing - False Alarm Score
Timeframe: At Baseline and week 17
Correlation between the changes in regional brain hemodynamic response during working memory tasks, as measured using cognitive fMRI with the scores of working memory, as measured by the CANTAB
Timeframe: At baseline and Week 17
Change in Rapid Visual Information Processing - Median Latency Score Per-Participant Over all Blocks
Timeframe: At Baseline and week 17
Interventions:
Enrollment:
80
Primary completion date:
2015-06-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Growth and Development
Product
Not applicable
Collaborators
Mahajan Imaging Center
Study date(s)
October 2014 to April 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
11 - 12 years
Accepts healthy volunteers
Yes
- Voluntary written informed consent from participant’s parents/ legally acceptable representative (LAR) and voluntary written assent from the subject and a signed, dated copy of the informed consent and assent forms.
- Right handed, School going children (participants) aged 11-12 years, inclusive
- Child in Care (CiC); A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. A CiC does not include a child who is adopted or has an appointed legal guardian.
- Known or suspected intolerance or hypersensitivity to the study materials, any of their stated ingredients or any known food allergies like nut allergy, gluten allergy or lactose intolerance.
Inclusion and exclusion criteria
Inclusion criteria:
- Voluntary written informed consent from participant’s parents/ legally acceptable representative (LAR) and voluntary written assent from the subject and a signed, dated copy of the informed consent and assent forms.
- Right handed, School going children (participants) aged 11-12 years, inclusive
- Satisfactory completion of baseline imaging scan basis participant’s ability to stay still, with acceptable MRI/fMRI image quality as determined by technical expert at the imaging centre
- Compliance of participant and participant’s parents/LAR with all study procedures and restrictions.
- Participant is able to read and comprehend one of the languages used for cognitive assessment (English or Hindi)
- Participant with Z-scores of Body Mass Index (BMI) for age of >-2 to <+1
Exclusion criteria:
- Child in Care (CiC); A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. A CiC does not include a child who is adopted or has an appointed legal guardian.
- Known or suspected intolerance or hypersensitivity to the study materials, any of their stated ingredients or any known food allergies like nut allergy, gluten allergy or lactose intolerance.
- Severe anemia with hemoglobin<8g/Dl, Attention Deficit Hyperactivity Disorder (ADHD), reading dyslexia or any other behavioral disorder.
- Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit or previous participation in this study.
- Participation in any nutritional study within 6 months prior to the screening visit.
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder
- Health conditions affecting food metabolism including food allergies, kidney disease, liver disease and/or gastrointestinal diseases.
- Use of concomitant medication that might interfere with the outcome of the study or increases the risk to the participant.
- Currently taking any other health food drinks/beverages or supplements (including nutritional supplements) or has been on supplements within a month prior to study start.
- Participant whose sibling is already a participant of this study.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-06-04
Actual study completion date
2015-06-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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