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

NCT04213456 | Active Not Recruiting

• 1 other identifier: RMC0888-18ctil
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Supplementation; Growth

Keywords

sport performance

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• weight-SDS

  at 4 months

• BMI-SDS

  at 4 months

Other Outcomes (5)

• Average daily caloric intake

  at 4 months

• Average daily macronutrients intake

  at 4 months

• Average daily micronutrients intake

  at 4 months

Study Arms (2)

Nutritional supplementation

EXPERIMENTAL

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

Dietary Supplement: Nutritional Sport Formula

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Nutritional Sport Formula DIETARY_SUPPLEMENT

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

Nutritional supplementation

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Young soccer players aged 8-15 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead
• NG Solutions Ltd: collaborator

Study Sites (1)

Schnider Children's Medical Center

Petah Tikva, 4920235, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: December 30, 2019
• Study Start: February 3, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

IL (1)