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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04213456
Other study ID # RMC0888-18ctil
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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