A Double Blind Randomized Controlled Trial in School Going Children, to Evaluate the Impact of a Multiple Micronutrient Fortified Nutritional Powder on Physical Performance Measures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months
研究概览
简要总结
The purpose of this study is to evaluate the effect of nutritional supplement on physical performance measures of apparently healthy school going children in India.
详细描述
Nutritional status may be important in achieving optimal physical performance. There is evidence of significant improvements in physical fitness, aerobic capacity and anaerobic threshold of children and adolescents with nutritional intervention, albeit in children with initial sub-optimal nutritional status. This may be of particular relevance in developing countries like India, where there is limited data on physical fitness and a wide-spread prevalence of concurrent micronutrient deficiencies even in apparently normal school age children. The present study therefore, is designed to assess the effect of a nutritional supplement on the physical performance measures of school going children. This is a randomized, double blind placebo-controlled study of three treatment groups (1 test, 1 positive control (placebo) and 1 'no intervention') conducted in equal numbers of male or female children [ages 7-11] attending day schools in Bangalore. Subjects in the intervention (test and positive control) groups will receive study treatments (fortified or un-fortified nutritional powder) once a day for 4 months. The treatments will be administered under supervision on all school working days; for the weekend and other holidays, sachets will be provided for home consumption. At baseline and 4months, physical performance tests will be administered and blood sample drawn to assess nutritional status. Other selected outcome measures such as nutrition status and muscle strength/ endurance will also be assessed. It is hypothesized that after 4 months of intervention, children consuming fortified nutritional powder will have statistically significant improvements in physical performance/ fitness measures as compared to the two control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Boys and girls between ages 7-10.5 years
- •Z score of height for age and weight for age of 0 to < -3
- •Good general health at screening
- •Understands and is willing, able and likely to comply with all study procedures and restrictions
- •Written informed consent from the parents/ guardians and writtent assent by the study participant
排除标准
- •Severe anemia (Hb<8 g% )
- •Cardiovascular disease on clinical examination or history
- •Any underlying respiratory disease with impairment of lung function
- •Physical disability Children consuming nutritional supplements (tonics, syrups, tablets or chews) and/ or health food drinks on a regular basis
- •Recent history [3mo] of serious infections, injuries and/ or surgeries
- •Participation in any nutritional study in the last 1 year
- •Indication that they are likely to move within the period of study intervention
- •Any known food allergies like peanut allergy, gluten allergy
- •Family members of an employee of the Sponsor or the study site.
结局指标
主要结局
Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months
时间窗: Baseline, after 4 months
Maximal aerobic capacity (VO2max) is defined as the maximum rate of oxygen consumption, measured during incremental exercise. VO2max was measured with the help of an externally placed 12-inch step test to assess the aerobic fitness/cardio-respiratory endurance of the study participants. In this test, participants were asked to step at 22 steps a minute for 3 minutes. The pulse rate was recorded manually, within 15sec of stopping the test. VO2max was calculated as (VO2 x HRmax) divided by HR observed, where HRmax = 220-Age in years. HRmax= maximum heart rate. VO2 is equal to (0.2 x Stepping Rate) + (2.4 x Step height x Stepping Rate) + 3.5 mL/kg/min. mL/kg/min.= milliliter per kilogram per minute.
Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months
时间窗: Baseline, after 4 months
A 40m sprint was used to assess speed with time taken to complete the sprint being recorded manually using a digital stopwatch. The moment any part of the designated participant's body reached the marker level, the corresponding examiner stopped their watches and recorded the time for the sprint.
Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months
时间窗: Baseline, after 4 months
Aerobic capacity(VO2peak) is defined as maximum rate of oxygen consumption attained on a particular exercise test. VO2peak was measured by 20m shuttle run test to assess aerobic \& whole body endurance. In this test, participants were asked to move around one cone to another placed at 19m distance, reversing direction \& in accordance with a pace dictated by sound signal, that got progressively faster at one minute intervals. The initial pace was set at 4.0 km/hr \& with subsequent increases of 0.5 km/hr every subsequent minute. This test was conducted in groups (of at least 3 children per group). The shuttle was stopped when either the participant chose to stop because of exhaustion or when participant was \> 1m away from cone at 2 consecutive paced signals. The number of shuttles at stoppage was noted. VO2peak was calculated as 31.025 + (3.325 x speed) - (3.248 x age). Speed is speed attained in previous level of shuttle, computed as speed (km/hr) = v + 0.5 x n/60; and age is in years.
Change From Baseline in Visual Reaction Time After 4 Months
时间窗: Baseline, after 4 months
Visual reaction time was assessed using a customized computer based programme. Participant was provided with a periodic random test visual stimulus among many other 'non test' stimuli. Participant was required to tap the space bar of the computer as fast as possible on the appearance of the test visual stimulus. Three test visual cues were provided at each sitting to allow for training effects. The shortest visual reaction time of the three visual cues was used in analyses.
次要结局
- Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months(Baseline, after 4 months)
- Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months(Baseline, after 4 months)
- Change From Baseline in Ferritin Level After 4 Months(Baseline, after 4 months)
- Change From Baseline in C-reactive Protein Level After 4 Months(Baseline, after 4 months)
- Change From Baseline in Rate of Decline of Muscle Strength After 4 Months(Baseline, after 4 months)
- Change From Baseline in Vitamin B2 Level After 4 Months(Baseline, after 4 months)
- Change From Baseline in Folate Level After 4 Months(Baseline, after 4 months)
- Change From Baseline in Time to Fatigue After 4 Months(Baseline, after 4 months)
- Change From Baseline in Hemoglobin Level After 4 Months(Baseline, after 4 months)
- Change From Baseline in Vitamin B6 Level After 4 Months(Baseline, after 4 months)
- Change From Baseline in Vitamin B12 Level After 4 Months(Baseline, after 4 months)
- Change From Baseline in Vitamin C Level After 4 Months(Baseline, after 4 months)