Nutrition, Physical Performance & Fitness in Indian School Children

NCT00876018 | Completed Phase 4 Results

• 1 other identifier: IND 001/2008
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Fitness; Nutritional Status

Keywords

physical performance; micronutrients; physical fitness; healthy children

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand 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 Rate of Decline of Muscle Strength After 4 Months

  Baseline, after 4 months

• Change From Baseline in Hemoglobin Level After 4 Months

  Baseline, after 4 months

• Change From Baseline in Ferritin Level After 4 Months

  Baseline, after 4 months

Study Arms (3)

No intervention

NO INTERVENTION

No intervention

Nutritional supplement

EXPERIMENTAL

Fortified nutritional powder

Other: Nutritional supplement

Placebo

PLACEBO COMPARATOR

Un-fortified nutritional powder

Other: Placebo

Interventions

Nutritional supplement OTHER

Fortified nutritional powder

Nutritional supplement

Placebo OTHER

Un-fortified nutritional powder

Placebo

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bangalore, Karnataka, 560034, India

Location

Related Publications (2)

• Desai IK, Kurpad AV, Chomitz VR, Thomas T. Aerobic fitness, micronutrient status, and academic achievement in Indian school-aged children. PLoS One. 2015 Mar 25;10(3):e0122487. doi: 10.1371/journal.pone.0122487. eCollection 2015.

  PMID: 25806824 DERIVED

• Vaz M, Pauline M, Unni US, Parikh P, Thomas T, Bharathi AV, Avadhany S, Muthayya S, Mehra R, Kurpad AV. Micronutrient supplementation improves physical performance measures in Asian Indian school-age children. J Nutr. 2011 Nov;141(11):2017-23. doi: 10.3945/jn.110.135012. Epub 2011 Sep 14.

  PMID: 21918063 DERIVED

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: July 7, 2008
• Primary Completion: December 19, 2008
• Study Completion: December 19, 2008
• Last Updated: March 1, 2018
• Results First Posted: August 3, 2017

Record last verified: 2018-02

Locations

IN (1)