Effect of zinc gluconate supplementation on nutritional status, exercise performance and some of the biochemical parameters in Boccia paralympic athletes

Determining the effect of zinc gluconate supplementation on nutritional status, athletic performance, and some biochemical parameters in Paralympic Boccia athletes

a double-blind, randomized controlled clinical trial that will be conducted on 24boccia athletes in Tabriz.

This study will be conducted on boccia athletes in Tabriz. Eligible individuals will complete a written consent form and general information. Individuals will be randomly divided into two groups using RASS software. Anthropometric measurements including weight, height, BMI calculation, arm circumference and skinfold fat thickness of the triceps muscle area will be taken at the beginning and end of the study, and weighing with and without a wheelchair on a scale will be used to determine weight. Questionnaires on general characteristics, appetite, and a three-day food record will be completed. Also, a 5-cc blood sample will be taken up to 24 hours after the training session, to determine serum levels of biochemical indicators. also Evaluations related to sports performance will be taken.

Inclusion criteria included athletes with physical and motor disabilities; age between 18 and 40 years; at least 2 years of training experience and willingness to participate in the study. Exclusion criteria: less than 2 years of training experience; swallowing disorders; chronic diseases such as diabetes, lipid disorders, liver failure, etc.; use of epilepsy drugs and corticosteroids; severe allergic reaction to the supplement or placebo; use of smoking, alcohol, and hookah.

The intervention group will take a daily supplement of 30 mg zinc gluconate and the control group will take the same dose, volume, shape, and taste of a maltodextrin placebo, preferably with a snack other than milk, for 8 weeks.

Nutritional status, athletic performance, and some biochemical parameters

Participants will be randomly assigned to either the intervention or placebo group using simple randomization through the Random Allocation Software (RASS). This software will automatically generate a random allocation sequence in which each participant will have an equal probability (50%) of being assigned to one of the two groups. In this method, the allocation of each individual will be entirely independent of others, and the order of participant enrollment will not influence the randomization process. To ensure allocation concealment, the random codes generated by the software will be placed in sealed, opaque, and sequentially numbered envelopes, to be opened in the order of participant enrollment. These codes will only indicate group designation (Group A or Group B), and both the investigators and participants will remain blinded to the actual content of the intervention (supplement or placebo) until data collection is complete. This procedure is intended to minimize allocation bias and enhance the internal validity of the study.

In this study, in order to minimize bias and enhance the validity of the results, a double-blind design will be employed, whereby neither the participants nor the principal investigator will be aware of the group assignments (intervention or control). The blinding process will be implemented according to the following steps: First, eligible participants will be randomly assigned to either the intervention or control group. To maintain impartiality, the allocation will be performed by an independent individual who will not be involved in data collection or data analysis. The intervention supplement and the placebo will be identical in appearance, color, size, odor, and packaging, and will be prepared by a pharmaceutical company. Each participant will receive the assigned product based on numerical coding (e.g., A and B). These codes will remain confidential with the individual responsible for blinding until the completion of data analysis. All participants will receive standardized instructions on how to consume the supplement, without any knowledge of their group assignment. Furthermore, the researcher responsible for data collection and analysis will remain blinded to the group allocations throughout the study. After the data collection phase is complete, the codes will be unblinded and the data will be analyzed accordingly. The use of this approach is expected to minimize the risk of both conscious and unconscious bias on the part of the researcher and the participants, thereby improving the internal validity of the study.

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