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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04213456
Enrollment
50
Registered
2019-12-30
Start date
2020-02-03
Completion date
2025-03-31
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth, Nutritional Supplementation

Keywords

sport performance

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.

Interventions

DIETARY_SUPPLEMENTNutritional Sport Formula

Powder added to water,high protein and multi vitamins and minerals

DIETARY_SUPPLEMENTPlacebo

Low caloric formula (Powder added to water), without added vitamins and minerals.

Sponsors

NG Solutions Ltd
CollaboratorUNKNOWN
Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
8 Years to 15 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

MeasureTime frameDescription
BMI-SDSat 4 monthsChange in standard deviation score of subject's BMI between baseline and 4 months
weight-SDSat 4 monthsChange in standard deviation score of subject's weight between baseline and 4 months

Other

MeasureTime frame
Average daily caloric intakeat 4 months
Average daily duration of sedentary activityat 4 months
Average weekly duration of physical activityat 4 months
Average daily micronutrients intakeat 4 months
Average daily macronutrients intakeat 4 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026