Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cognition

Treatments: Dietary Supplement: Beverage powder fortified with micronutrients and Bacopa monnieri extract; Other: Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02416245

202379

Details and patient eligibility

About

The aim of the current study is to investigate the beneficial impact of 4 month consumption of a beverage powder fortified with Brahmi (Bacopa monnieri) extract and multiple vitamins and minerals on short term memory as assessed using standardised cognitive test battery.

Full description

Bacopa monnieri (Brahmi) from Scrophulariaceae family has been traditionally used in India as 'memory tonic'. Brahmi's use as a cognitive enhancer has led to recent research to investigate a broad spectrum of cognitive domains. Additionally, micronutrient deficiency in children can impair cognitive functions, and micronutrient supplementation can help reduce/prevent deficiencies in those at risk. Several studies have been conducted so far which establish the cognition enahncing abilities of Brahmi, with no major side effects. The aim of the current study is to investigate the beneficial impact of 4 month consumption of a beverage powder fortified with Brahmi extract and multiple vitamins and minerals on short term memory as assessed using standardised cognitive test battery.

Enrollment: 310 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Z-score of Body Mass Index (BMI) for age of >-2 to <-1
• Participant and participant's parents/legally authorized representatives (LAR) understand and are willing, able and likely to comply with all the study procedures
• Participant is in good general health; has no condition that could affect the safety of participant

Exclusion criteria

• Child in care: A child who is placed under the control/protection of an agency/organization/institution by the court/government
• Allergy/Intolerance/Hypersensitivity any study ingredient
• Severe anaemia (Hb<8g/dL); Attention Deficit Hyperactivity Disorder; Reading dyslexia or behavioral disorders
• Health condition that could affect food metabolism; any physical or psychiatric illness that could lead to non-completion of study
• Concurrent use of other health food drinks/supplements, within 1 month prior to study start
• Sibling participation in study

Trial design

310 participants in 2 patient groups, including a placebo group

Test beverage powder

Experimental group

Description:

Test beverage powder is fortified with micronutrients and Bacopa monnieri extract. Each sachet contains 32g of treatmemt product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily

Treatment:

Dietary Supplement: Beverage powder fortified with micronutrients and Bacopa monnieri extract

Control beverage powder

Placebo Comparator group

Description:

Control beverage powder is the non-fortified isocaloric powder i.e. without micronutrients and Bacopa Monnieri extract. Each sachet contains 32g of placebo product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily

Treatment:

Other: Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)