Clinical trial NCT04213456: Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players
Official title: Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nutritional Supplementation
Growth
Keywords: sport performance
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: NG Solutions Ltd
First posted: 2019-12-30
Enrollment: 50
Sex: MALE
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Height SDS (standard deviation score)
timeFrame: at 4 months
measure: 10m sprint score
timeFrame: at 4 months
measure: 20m sprint score
timeFrame: at 4 months
measure: Countermovement Jump (CMJ) score
timeFrame: at 4 months
measure: Agility test score
timeFrame: at 4 months
measure: The Yo-Yo Intermittent Recovery Test Level 1 (Yo-Yo IR1) score
timeFrame: at 4 months
Secondary outcomes:
measure: weight-SDS
timeFrame: at 4 months
measure: BMI-SDS
timeFrame: at 4 months
Other outcomes:
measure: Average daily caloric intake
timeFrame: at 4 months
measure: Average daily macronutrients intake
timeFrame: at 4 months
measure: Average daily micronutrients intake
timeFrame: at 4 months
measure: Average weekly duration of physical activity
timeFrame: at 4 months
measure: Average daily duration of sedentary activity
timeFrame: at 4 months
Locations:
city: Petach-Tikva
country: Israel
facility: Schnider Children's Medical Center
Study officials:
References: