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IRCT20250506065624N2 IRCT 2025-05-24 Tabriz University of Medical Sciences Effect of zinc gluconate supplementation on nutritional status, exercise performance and some of the biochemical parameters in Boccia paralympic athletes Effect of zinc gluconate supplementation on nutritional status, exercise performance and some of the biochemical parameters in Boccia paralympic athletes 2025-05-26 anticipated 24 Complete https://irct.ir/trial/83413 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Boccia athletes with cerebral palsy. Intervention 1: Intervention group: 12 athletes from Tabriz city, whose anthropometric measurements, sports performance, blood sampling and questionnaire completion will be taken at the beginning of the study. Then, these individuals will receive 30 mg zinc gluconate supplement, 1 tablet daily for 8 weeks, and again at the end of the study, measurements related to anthropometry, sports performance, blood sampling and questionnaire completion will be taken. Intervention 2: Control group: 12 Boccia athletes from Tabriz city, who will have anthropometric measurements, sports performance, blood sampling, and questionnaire completion at the beginning of the study. Then, these individuals will receive 1 tablet of maltodextrin placebo with the same dose, volume, shape, size, taste, and smell daily for 8 weeks, and again at the end of the study, measurements related to anthropometry, sports performance, blood sampling, and questionnaire completion will be taken. No - There is not a plan to make this available Justification or reason for not sharing IPD is there are not extra data more than results presented in our articles
public Seyed Sajjad Niknam
Faculty of Nutrition and Food Sciences, Attar Neishabouri Street, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665931 +98 21 6511 4742 sajjadniknam257@gmail.com Tabriz University of Medical Sciences scientific Vahideh Ebrahimzadeh Attari
Faculty of Nutrition and Food Sciences, Attar Neishabouri Street, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5165665931 +98 41 3727 5552 ebrahimzadehv@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Athletes with physical and mobility disabilities Age between 18 years and 40 years At least two years of practice experience Willing to participate in the study 18 years 40 years Both Treatment - Drugs Treatment - Drugs Intervention group: 12 athletes from Tabriz city, whose anthropometric measurements, sports performance, blood sampling and questionnaire completion will be taken at the beginning of the study. Then, these individuals will receive 30 mg zinc gluconate supplement, 1 tablet daily for 8 weeks, and again at the end of the study, measurements related to anthropometry, sports performance, blood sampling and questionnaire completion will be taken. Control group: 12 Boccia athletes from Tabriz city, who will have anthropometric measurements, sports performance, blood sampling, and questionnaire completion at the beginning of the study. Then, these individuals will receive 1 tablet of maltodextrin placebo with the same dose, volume, shape, size, taste, and smell daily for 8 weeks, and again at the end of the study, measurements related to anthropometry, sports performance, blood sampling, and questionnaire completion will be taken. Nutritional status (energy intake, macronutrients, micronutrients, anthropometric indices, appetite). Timepoint: Beginning and end of the study. Method of measurement: Anthropometric measurements including weight, height, BMI calculation, determination of arm circumference and thickness of skinfold fat of the triceps muscle area using calipers will be performed by the researcher at the beginning and end of the study. Considering the severe physical and motor disability of the athletes, weighing with and without a wheelchair on a scale with an accuracy of 0.1 kg will be used to determine weight. A tape measure with an accuracy of 0.1 cm will be used to measure height and alternative methods of determining height such as ulna or determining the length of the lower leg. Initially, the study participants will use a 5-item questionnaire based on a Likert scale (answers 0 to 10) to determine appetite, the validity and reliability of which have been previously determined, and a 3-day food record will be performed to determine calorie and nutrient intake. Athletic performance (throwing distance, muscle strength). Timepoint: Beginning and end of the study. Method of measurement: At the beginning and end of the study, after the eligible individuals have been selected and grouped, the researcher and the assistant coach in charge measure the participants' throwing distance and the individuals' muscular strength using a hand grip device, and the results before and after are compared and evaluated based on existing standards. On some biochemical parameters (serum levels of lactate dehydrogenase, creatine kinase, serum zinc, growth hormone, IGF1 and testosterone). Timepoint: Beginning and end of the study. Method of measurement: At the beginning and end of the study, a 5cc blood sample will be taken the morning after the training session, following a 10 to 12 hour fast, to determine serum levels of some biochemical indicators, including serum levels of creatine kinase, growth hormone, IGF1, lactate dehydrogenase, serum zinc, testosterone, fasting blood sugar, and lipid profile. Tabriz University of Medical Sciences Approved 2025-04-14 Ethics committee of Tabriz University of Medical Sciences Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)