Impact of a Beverage Powder Fortified With Multiple Micronutrients (MMN) and Bacopa Monnieri Extract (EBM) on Cognitive Variables in Indian School Children (7-12yrs; Inclusive) After 4 Months of Intervention: a Double Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- 'Between errors' in CANTAB task 'Spatial working memory'
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
'Between errors' in CANTAB task 'Spatial working memory'
时间窗: Baseline to 4 months
'Spatial working memory' task measures the 'Short term memory' (working memory). In this task, participants search through a series of boxes until they find a blue chip, which they move to the "home" area on right side of screen. They then look for the next blue chip but NOT in same box as before. For each problem, the participant must NOT return to a box they have previously found a blue chip in. Number of boxes is gradually increased from 3 to 8. 'Between errors' is defined as times the participant revisits a box in which a token has previously been found. This is calculated for all trials of four or more tokens only. Scale ranges from 0 to 180 with lower score indicating a better performance.
'Strategy' in CANTAB task 'Spatial working memory'
时间窗: Baseline to 4 months
'Spatial working memory' task measures the 'Short term memory' (working memory). In this task, participants search through a series of boxes until they find a blue chip, which they move to the "home" area on right side of screen. They then look for the next blue chip but NOT in same box as before. Number of boxes is gradually increased from 3 to 8. 'Strategy' is defined as number of distinct boxes used by the participant to begin a new search for a token, within the same problem. Scale ranges from 4 to 28 with a lower score indicating a better performance.
次要结局
- 'A Prime' in CANTAB task 'Rapid Visual Information Processing'(Baseline to 4 months)
- 'Total errors (adjusted)' in CANTAB task 'Paired associate learning'(Baseline to 4 months)
- 'Problems solved in minimum moves' in CANTAB task 'Stockings of Cambridge'(Baseline to 4 months)
- 'Median latency' in CANTAB task 'Rapid Visual Information Processing'(Baseline to 4 months)
- 'Total false alarms' in CANTAB task 'Rapid Visual Information Processing'(Baseline to 4 months)
- CANTAB Score on 'Raven's colored progressive matrices'(Baseline to 4 months)