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IRCT20150205020965N8 IRCT 2021-02-13 Tabriz University of Medical Sciences The effect of Tribulus terrestris in runners The effect of Tribulus terrestris supplementation on the nutritional, oxidative, inflammatory, and anti-inflammatory status and sport performance in runners 2021-02-20 anticipated 34 Complete https://irct.ir/trial/54158 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: After stratified random matching, individuals will be divided into two groups of intervention (Tribulus terrestris supplementation and physical activity; 17 persons) and control (maltodextrin supplementation and physical activity; 17 persons) based on gender and VO2max using RAS software, Blinding description: The intervention group and the control group will consume two capsules of Tribulus terrestris (500 mg) and two capsules of maltodextrin (500 mg) each day respectively for two weeks, which is accompanied by high-intensity interval training. Supplement and placebo will be coded with codes 1 and 2. Until the release of the patient study results, the researcher and data analyzer will not be aware of the assigned codes. 3 runners. Intervention 1: Intervention group: The intervention group will consume two capsules of Tribulus terrestris (500 mg) each day, which is accompanied by high-intensity interval training. One of the capsules would be taken after breakfast and the other one would be taken after lunch. To ensure the supplement consumption and follow up the recreational runners' problems, the delivery of unused capsules will be requested at the end of each week. Study subjects will be asked to report any problems too. To apply the exercise protocol, the study subjects will do high-intensity interval training for five days each week (during two weeks). Intervention 2: Control group: The control group will consume two capsules of maltodextrin (500 mg) each day, which is accompanied by high-intensity interval training. One of the capsules would be taken after breakfast and the other one would be taken after lunch. To ensure the supplement consumption and follow up the recreational runners' problems, the delivery of unused capsules will be requested at the end of each week. Study subjects will be asked to report any problems too. To apply the exercise protocol, the study subjects will do high-intensity interval training for five days each week (during two weeks). Yes - There is a plan to make this available What will be shared: Reporting the results When: After finishing the study and publishing the project articles To whom: Academic researchers Conditions: With permission of Project Researcher and Project Sponsor - Nutrition Research Center Where to obtain: Dr. Parvin Dehghan, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences Email: Dehghan.nut@gmail.com Phone: +98 914 471 0299 How to obtain: The applicant can send an application to the responsible person by email Comments:
public Parvin Dehghan
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3334 0634 dehghan.nut@gmail.com Tabriz University of Medical Sciences scientific Parvin Dehghan
Attar Neyshabori Street, Golghash street, Nutrition Faculty, Tabriz University Of Medical Sciences,
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 dehghanp@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) The age range of 18 to 35 years Do running workouts for at least 3 days a week (240 minutes per week) during the last 2 years Complete health (confirmed by PAR-Q questionnaire under the supervision of a doctor) The body mass index of 18.5-25 Not receiving Tribulus terrestris supplement in the last three months Not doing high-intensity interval training during the last two weeks Willingness to cooperate in the study 18 years 35 years Both Musculoskeletal injuries Smoking Alcohol consumption Hormone therapy Long-term use of drugs and dietary supplements Intake of antihypertensives, diuretics and antidiabetics Pregnancy Lactation Diabetes Anemia (Hb <13g / dl) Cardiovascular disease Infectious diseases Gastrointestinal problems Malignancies Cognitive disorders Y93.02 Activity, running Prevention Placebo Intervention group: The intervention group will consume two capsules of Tribulus terrestris (500 mg) each day, which is accompanied by high-intensity interval training. One of the capsules would be taken after breakfast and the other one would be taken after lunch. To ensure the supplement consumption and follow up the recreational runners' problems, the delivery of unused capsules will be requested at the end of each week. Study subjects will be asked to report any problems too. To apply the exercise protocol, the study subjects will do high-intensity interval training for five days each week (during two weeks). Control group: The control group will consume two capsules of maltodextrin (500 mg) each day, which is accompanied by high-intensity interval training. One of the capsules would be taken after breakfast and the other one would be taken after lunch. To ensure the supplement consumption and follow up the recreational runners' problems, the delivery of unused capsules will be requested at the end of each week. Study subjects will be asked to report any problems too. To apply the exercise protocol, the study subjects will do high-intensity interval training for five days each week (during two weeks). Malondialdehyde. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Total antioxidant capacity. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Superoxide dismutase. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Hs-CRP. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. IL-6. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. IL-10. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Creatine kinase. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Lactate dehydrogenase. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Sport performance. Timepoint: At baseline and two weeks after baseline. Method of measurement: questionnaire. Ferritin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Serum iron. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Insulin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Glucose. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Insulin-like Growth Factor-1. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Adiponectin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. PGC-1alpha expression. Timepoint: At baseline and two weeks after baseline. Method of measurement: pcr. Tumor necrosis factor alpha. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. α1-acid glycoprotein. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Myoglobin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Irisin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Cortisol. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Brain-Derived Neurotrophic Factor. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. F2-isoprostanes. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. 8-Oxo-2'-deoxyguanosine. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. GSH. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Carbonyl. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Nitric Oxide. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Neopterin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Nutritional status (energy and macronutrients intake). Timepoint: At baseline and two weeks after baseline. Method of measurement: 3-days food intake record. Body composition. Timepoint: At baseline and two weeks after baseline. Method of measurement: (BIA, BC-418 MA). Transferrin. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. CBC. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Serum iron. Timepoint: At baseline and two weeks after baseline. Method of measurement: Kit. Sleep. Timepoint: At baseline and two weeks after baseline. Method of measurement: Questionnaire. Recovery and stress. Timepoint: At baseline and two weeks after baseline. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2021-01-25 Ethics committee of Tabriz University of Medical Sciences Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street. Tabriz East Azarbaijan Iran (Islamic Republic of)