Nutritional SupplementationNCT04213456
Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players
A study testing Nutritional Sport Formula in people with Nutritional Supplementation and Growth, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 8 to 15 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional Supplementation, Growth
- What is being tested?
- Nutritional Sport Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Feb 2020to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Young soccer players aged 8-15 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Nutritional Sport Formula, Placebo
- Keywords
- sport performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Sport FormulaDietary supplement
Powder added to water,high protein and multi vitamins and minerals
PlaceboDietary supplement
Low caloric formula (Powder added to water), without added vitamins and minerals.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplementation | Experimental | Powder added to water,high protein and multi vitamin and minerals Receives: Dietary Supplement: Nutritional Sport Formula |
| Placebo | Placebo comparator | Low caloric formula (Powder added to water), without added vitamins and minerals. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height SDS (standard deviation score)
Change in standard deviation score of participant's height between baseline and 4 months
Measured: at 4 months
10m sprint score
Change in 10m sprint score between baseline and 4 months (test the speed and acceleration of the player)
Measured: at 4 months
20m sprint score
Change in 20m sprint score between baseline and 4 months (test the speed and acceleration of the player)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 4 months
Secondary outcomes (2)
weight-SDS
Change in standard deviation score of subject's weight between baseline and 4 months
Measured: at 4 months
BMI-SDS
Change in standard deviation score of subject's BMI between baseline and 4 months
Measured: at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start3 Feb 2020
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NG Solutions Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213456
- Sponsor's protocol ID
- RMC0888-18ctil
- Status last verified
- Mar 2024
- First submitted
- 26 Dec 2019
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo Controlled Pilot Study to Evaluate the Effect of Nutritional Supplementation on Physical Activity Performance of Young Soccer Players
- ClinicalTrials.gov ID
- NCT04213456
- Acronym / sponsor ID
- RMC0888-18ctil
- Conditions
- Nutritional Supplementation, Growth
- Keywords
- sport performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- NG Solutions Ltd
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplementation | Experimental | Dietary Supplement: Nutritional Sport FormulaPowder added to water,high protein and multi vitamin and minerals |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboLow caloric formula (Powder added to water), without added vitamins and minerals. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Young soccer players aged 8-15 years old
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Sport FormulaPowder added to water,high protein and multi vitamins and minerals | Dietary supplement | Nutritional supplementation |
| PlaceboLow caloric formula (Powder added to water), without added vitamins and minerals. | Dietary supplement | Placebo |
Primary outcome
Height SDS (standard deviation score)
Time frame: at 4 months
Change in standard deviation score of participant's height between baseline and 4 months
10m sprint score
Time frame: at 4 months
Change in 10m sprint score between baseline and 4 months (test the speed and acceleration of the player)
20m sprint score
Time frame: at 4 months
Change in 20m sprint score between baseline and 4 months (test the speed and acceleration of the player)
Countermovement Jump (CMJ) score
Time frame: at 4 months
Change in Countermovement Jump (CMJ) score between baseline and 4 months (assess explosive strength of the lower extremity muscles)
Agility test score
Time frame: at 4 months
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)
The Yo-Yo Intermittent Recovery Test Level 1 (Yo-Yo IR1) score
Time frame: at 4 months
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)
2 secondary outcomes
weight-SDS
Time frame: at 4 months
BMI-SDS
Time frame: at 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Sport Formula in people with Nutritional Supplementation and Growth, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height SDS (standard deviation score) (time frame: at 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.