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

Clalit Health Services

Status: Active, not recruiting

Conditions: Nutritional Supplementation; Growth

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Nutritional Sport Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT04213456

RMC0888-18ctil

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 8 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Nutritional supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nutritional Sport Formula

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo