MedPath

Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players

Not Applicable
Active, not recruiting
Conditions
Growth
Nutritional Supplementation
Interventions
Dietary Supplement: Placebo
Dietary Supplement: Nutritional Sport Formula
Registration Number
NCT04213456
Lead Sponsor
Rabin Medical Center
Brief Summary

Research has clearly shown that lacking sufficient calories, macro- and micro-nutrients may impair an athlete's training adaptations, while athletes who consume a balanced diet that meets energy needs can enhance physiological training adaptations. Maintaining an energy and nutrient deficient diet during training may lead to loss of muscle mass, strength, and bone mineral density, in addition to an increased susceptibility to illness and injuries, disturbances in immune, endocrine and reproductive function, and an increased prevalence of overreaching and/or overtraining. In children and adolescent athletes, an insufficient diet may additionally result in impaired physical growth. Incorporating good dietary practices as part of a training program is one way to help optimize training adaptations and prevent overtraining.

Based on this, nutritional supplementation is an effective and safe approach for attaining the high nutritional requirements of adolescent athletes, to help them maintain healthy growth. Nutritional supplementation could also improve their body composition, sport performance and general health. The primary objective of the proposed study is to evaluate the effect of dietary supplement versus placebo on growth and physical activity performance in young athletes. A total of 50 young soccer players (25 in each group) will participate in this Double blind, randomized, placebo controlled study.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Male
Target Recruitment
50
Inclusion Criteria
  • Young soccer players aged 8-15 years old
Exclusion Criteria
  • Diagnosis of GH Deficiency or treatment with GH
  • Any known chronic disease or dysmorphic syndrome including: organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, gastrointestinal disease including malabsorption and bone dysplasia.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboLow caloric formula (Powder added to water), without added vitamins and minerals.
Nutritional supplementationNutritional Sport FormulaPowder added to water,high protein and multi vitamin and minerals
Primary Outcome Measures
NameTimeMethod
Agility test scoreat 4 months

Change in Agility test score between baseline and 4 months(agility is the ability to change the direction of the body rapidly and is a result of a combination of strength, speed, balance and coordination)

Height SDS (standard deviation score)at 4 months

Change in standard deviation score of participant's height between baseline and 4 months

10m sprint scoreat 4 months

Change in 10m sprint score between baseline and 4 months (test the speed and acceleration of the player)

20m sprint scoreat 4 months

Change in 20m sprint score between baseline and 4 months (test the speed and acceleration of the player)

Countermovement Jump (CMJ) scoreat 4 months

Change in Countermovement Jump (CMJ) score between baseline and 4 months (assess explosive strength of the lower extremity muscles)

The Yo-Yo Intermittent Recovery Test Level 1 (Yo-Yo IR1) scoreat 4 months

Change in the Yo-Yo IR1 score between baseline and 4 months (The Yo-Yo IR test measure the ability to recover from intense exercise)

Secondary Outcome Measures
NameTimeMethod
weight-SDSat 4 months

Change in standard deviation score of subject's weight between baseline and 4 months

BMI-SDSat 4 months

Change in standard deviation score of subject's BMI between baseline and 4 months

Trial Locations

Locations (1)

Schnider Children's Medical Center

🇮🇱

Petach-Tikva, Israel

© Copyright 2025. All Rights Reserved by MedPath