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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Growth; Nutritional Supplementation
• Intervention / Treatment: Dietary supplement: Nutritional Sport Formula; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach-Tikva, Israel, 4920235
    • Schnider Children's medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional supplementation; Powder added to water,high protein and multi vitamin and minerals	Dietary supplement: Nutritional Sport Formula; Powder added to water,high protein and multi vitamins and minerals
Placebo Comparator: Placebo; Low caloric formula (Powder added to water), without added vitamins and minerals.	Dietary supplement: Placebo; Low caloric formula (Powder added to water), without added vitamins and minerals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height SDS (standard deviation score)	Change in standard deviation score of participant's height between baseline and 4 months	at 4 months
10m sprint score	Change in 10m sprint score between baseline and 4 months (test the speed and acceleration of the player)	at 4 months
20m sprint score	Change in 20m sprint score between baseline and 4 months (test the speed and acceleration of the player)	at 4 months
Countermovement Jump (CMJ) score	Change in Countermovement Jump (CMJ) score between baseline and 4 months (assess explosive strength of the lower extremity muscles)	at 4 months
Agility test score	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)	at 4 months
The Yo-Yo Intermittent Recovery Test Level 1 (Yo-Yo IR1) score	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)	at 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight-SDS	Change in standard deviation score of subject's weight between baseline and 4 months	at 4 months
BMI-SDS	Change in standard deviation score of subject's BMI between baseline and 4 months	at 4 months

Other Outcome Measures

Outcome Measure	Time Frame
Average daily caloric intake	at 4 months
Average daily macronutrients intake	at 4 months
Average daily micronutrients intake	at 4 months
Average weekly duration of physical activity	at 4 months
Average daily duration of sedentary activity	at 4 months

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: NG Solutions Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: December 26, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: sport performance
• Other Study ID Numbers: RMC0888-18ctil

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No