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

Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04213456
• Other study ID #: RMC0888-18ctil
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 8 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Growth
• Nutritional Supplementation

Intervention

Dietary Supplement:
• Nutritional Sport Formula
Powder added to water,high protein and multi vitamins and minerals
• Placebo
Low caloric formula (Powder added to water), without added vitamins and minerals.

Locations

Country	Name	City	State
Israel	Schnider Children's Medical Center	Petach-Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	NG Solutions Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Average daily caloric intake		at 4 months
Other	Average daily macronutrients intake		at 4 months
Other	Average daily micronutrients intake		at 4 months
Other	Average weekly duration of physical activity		at 4 months
Other	Average daily duration of sedentary activity		at 4 months
Primary	Height SDS (standard deviation score)	Change in standard deviation score of participant's height between baseline and 4 months	at 4 months
Primary	10m sprint score	Change in 10m sprint score between baseline and 4 months (test the speed and acceleration of the player)	at 4 months
Primary	20m sprint score	Change in 20m sprint score between baseline and 4 months (test the speed and acceleration of the player)	at 4 months
Primary	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
Primary	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
Primary	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	weight-SDS	Change in standard deviation score of subject's weight between baseline and 4 months	at 4 months
Secondary	BMI-SDS	Change in standard deviation score of subject's BMI between baseline and 4 months	at 4 months