Nutrition, Physical Performance & Fitness in Indian School Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Physical Fitness, Nutritional Status

Intervention / Treatment
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* Other: Nutritional supplement
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>No intervention | |
| Experimental: Nutritional supplement<br>Fortified nutritional powder | Other: Nutritional supplement<br>* Fortified nutritional powder<br>|
| Placebo Comparator: Placebo<br>Un-fortified nutritional powder | Other: Placebo<br>* Un-fortified nutritional powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test 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. | Baseline, after 4 months | 
| Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) 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. | Baseline, after 4 months | 
| Change From Baseline in Time Taken for 40 Meter (m) Sprint 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. | Baseline, after 4 months | 
| Change From Baseline in Visual Reaction Time 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. | Baseline, after 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months | Maximal handgrip strength was measured using a Jamar handgrip dynamometer in dominant and non-dominant arms. The width of the grip was noted during the pre-intervention assessment and kept constant for an individual during the subsequent post-intervention assessment. Muscle strength was recorded as the best (highest) value for the dominant and non-dominant sides as well as average value of the 3 measurements. | Baseline, after 4 months | 
| Change From Baseline in Time to Fatigue After 4 Months | Time to fatigue is defined as the time in seconds taken for the handgrip to fall from maximal value to 50% of the maximal value. Time to fatigue was measured using Jamar hand dynamometer to assess the muscle strength. In this test, participants were required to sustain a maximal contraction until the force dropped to 50% of its maximal value. | Baseline, after 4 months | 
| Change From Baseline in Rate of Decline of Muscle Strength After 4 Months | Rate of decline of muscle strength was assessed to measure the muscle endurance of forearm. Sustained isometric contraction of forearm flexors to 50% of maximal handgrip was measured using the Jamar hand dynamometer and was performed on the non-dominant arm. The participant was required to sustain a maximal contraction until the force dropped to 50% of its maximal value. Rate of decline of muscle strength was calculated as 50 percent of maximal value of contraction divided by time to fatigue (50%maximal value of contraction (MVC)/Time to fatigue). | Baseline, after 4 months | 
| Change From Baseline in Hemoglobin Level After 4 Months | Hemoglobin level was measured to assess the iron status in study participants. | Baseline, after 4 months | 
| Change From Baseline in Ferritin Level After 4 Months | Ferritin level was measured to assess the iron status of study participants. | Baseline, after 4 months | 
| Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months | Soluble transferring receptors (sTr) was measured to assess the iron status of study participants. | Baseline, after 4 months | 
| Change From Baseline in C-reactive Protein Level After 4 Months | C-reactive protein level was measured. | Baseline, after 4 months | 
| Change From Baseline in Vitamin B2 Level After 4 Months | Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants. | Baseline, after 4 months | 
| Change From Baseline in Vitamin B6 Level After 4 Months | Vitamin B6 level was measured as micronutrient markers in study participants. | Baseline, after 4 months | 
| Change From Baseline in Vitamin B12 Level After 4 Months | Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants. | Baseline, after 4 months | 
| Change From Baseline in Folate Level After 4 Months | Folate level was measured as micronutrient markers in study participants. | Baseline, after 4 months | 
| Change From Baseline in Vitamin C Level After 4 Months | Vitamin C level was measured as micronutrient markers in study participants. | Baseline, after 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical performance, micronutrients, physical fitness, healthy children