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IRCT20190906044711N1 IRCT 2020-08-03 Sports Science Unit, School of Medical Sciences, Universiti Sains Malaysia Effect of Carbohydrate and Protein Ingestion in Exercise EFFECTS OF COMBINED SAGO–SOY SUPPLEMENTATION ON CYCLING TIME TRIAL PERFORMANCE IN THE HEAT 2010-09-16 anticipated 15 Complete https://irct.ir/trial/48571 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this research, a randomised single–blind, placebo–controlled cross–over trial was applied. The study was designed to investigate the effects of iso–caloric sago and soy supplementations through a cycling performance. The protocol was similar to an actual race in which each cyclist consumed a type supplementation in one of the experimental trials with a one week washout period between the crossover phases. There were four experimental trials in this design where the participants were randomly assigned to consume either Sago, Soy, Sago+Soy, or Placebo before and during the experimental trials. Random number tables have been used for each supplement to assign the treatments among the participants, Blinding description: In the current study, all of the cyclists were blinded, and they were not informed about the type of supplementation as their taste was similar. In addition, the laboratory technicians were also not informed about the type of supplementation. The only person who was aware of the type of supplements was the Ph.D. candidate acting as the investigator. 3 To investigate the effects of sago (daily used local food containing mostly CHO), soy (daily used local food containing PRO), and iso–caloric sago+soy combined (CHO and PRO combined supplementation) supplementation during a 90–min endurance cycling at 60 % of VO2max on cycling performance in the heat. Intervention 1: Intervention group: Sago-These ingredients were sago flour (75 gr in 1 liter) that obtained from Sim Company Sdn. Bhd. Penang (Ghosh et al., 2010), and it was mixed with 5 mL of non–caloric chocolate flavour (Star Brand, FFM Marketing Sdn. Bhd., Selangor, Malaysia) in 1000 mL of each drink. The sago supplement was iso–caloric, and the energy value of them was estimated ~ 300 kcal. All participants were supplemented 5 times at 0, 20, 40, 60, and 80 minutes in the cycling. Intervention 2: Intervention group: Soy-These ingredients were soy flour (75 gr in 1 liter) that obtained from Sim Company Sdn. Bhd. Penang (Ghosh et al., 2010), and it was mixed with 5 mL of non–caloric chocolate flavour (Star Brand, FFM Marketing Sdn. Bhd., Selangor, Malaysia) in 1000 mL of each drink. The soy supplement was iso–caloric, and the energy value of them was estimated ~ 300 kcal. All participants were supplemented 5 times at 0, 20, 40, 60, and 80 minutes in the cycling. Intervention 3: Intervention group: Sago+Soy-The preparation of this supplement was similar to the sago or soy ingestions, but 60 g of sago flour and 15 g of soy flour were used (Ghosh et al., 2010). This supplement was mixed with 5 mL of non–caloric chocolate flavour (Star Brand, FFM Marketing Sdn. Bhd., Selangor, Malaysia) in 1000 mL of each drink. The Sago+Soy supplement was iso–caloric, and the energy value of them was estimated ~ 300 kcal. All participants were supplemented 5 times at 0, 20, 40, 60, and 80 minutes in the cycling. Intervention 4: Intervention group: Placebo-The non–caloric chocolate flavour was added to the boiled 1000 mL of distilled water. This solution was consumed as non–caloric supplementation of a placebo trial. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Daniel Tarmast
Department of Physical Education & Sport Sciences, Faculty of Humanities, Parand Branch, Islamic Azad University
Tehran Iran (Islamic Republic of) 3761396361 +98 21 5673 3125 danieltarmast@gmail.com Islamic Azad University scientific Daniel Tarmast
Parand new city-Bahonar street
تهران Iran (Islamic Republic of) 3761396361 +98 938 941 9439 danieltarmast@gmail.com Islamic Azad University Malaysia Non–smoker Non–diabetic Not using dietary supplements at the time of the study Having, at least, two years of participation in cycling training and competitions 15 years 30 years Male Y93.79 Activity, other specified sports and athletics Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: Sago-These ingredients were sago flour (75 gr in 1 liter) that obtained from Sim Company Sdn. Bhd. Penang (Ghosh et al., 2010), and it was mixed with 5 mL of non–caloric chocolate flavour (Star Brand, FFM Marketing Sdn. Bhd., Selangor, Malaysia) in 1000 mL of each drink. The sago supplement was iso–caloric, and the energy value of them was estimated ~ 300 kcal. All participants were supplemented 5 times at 0, 20, 40, 60, and 80 minutes in the cycling. Intervention group: Soy-These ingredients were soy flour (75 gr in 1 liter) that obtained from Sim Company Sdn. Bhd. Penang (Ghosh et al., 2010), and it was mixed with 5 mL of non–caloric chocolate flavour (Star Brand, FFM Marketing Sdn. Bhd., Selangor, Malaysia) in 1000 mL of each drink. The soy supplement was iso–caloric, and the energy value of them was estimated ~ 300 kcal. All participants were supplemented 5 times at 0, 20, 40, 60, and 80 minutes in the cycling. Intervention group: Sago+Soy-The preparation of this supplement was similar to the sago or soy ingestions, but 60 g of sago flour and 15 g of soy flour were used (Ghosh et al., 2010). This supplement was mixed with 5 mL of non–caloric chocolate flavour (Star Brand, FFM Marketing Sdn. Bhd., Selangor, Malaysia) in 1000 mL of each drink. The Sago+Soy supplement was iso–caloric, and the energy value of them was estimated ~ 300 kcal. All participants were supplemented 5 times at 0, 20, 40, 60, and 80 minutes in the cycling. Intervention group: Placebo-The non–caloric chocolate flavour was added to the boiled 1000 mL of distilled water. This solution was consumed as non–caloric supplementation of a placebo trial. The 20–km time trial performance in the heat,. Timepoint: At 20 min intervals during cycling at 60% VO2max, participants consumed either SA, SO, SS, or a PL. Method of measurement: This test was performed by using the electronically braked ergometer (Excalibur Sport, Lode, Groningen, The Netherlands). Participants were requested to perform the 20–km time trial on another bike (One Series Aluminium, Trek Road Bikes, USA). This bike was supported by a trainer (CycleOps Power JetFluid Pro Trainer, Wisconsin, USA). Meanwhile, they were free to control the speed of the cycling via a digital cyclometer (Cateye Strada Wireless, CC–RD300W, Japan). During the experimental trials, heart rate was measured by a heart rate monitor (S710, Polar Electro, Finland). A heart rate monitor sensor (Sport Tester, PE 3000, Polar Electro, Finland) was fitted on the chest wall of the participants’ body to transmit the data to the heart rate monitor. Blood glucose. Timepoint: The blood sampling (8 mL) were collected after at -30 min, 0 min, 30 min, 60 min, 90 min, and after time trial performance. Method of measurement: Enzymatic oxidation method was applied to analyse the plasma glucose concentration within 60 minutes by spectrophotometer (Spekol 1200, Germany). Free Fatty Acid. Timepoint: The blood sampling (8 mL) were collected after at -30 min, 0 min, 30 min, 60 min, 90 min, and after time trial performance. Method of measurement: Acyl–CoA synthetase–Acyl–CoA oxidase method (ACS–ACOD) was used to analyse the plasma Free Fatty Acid concentration by spectrophotometer (Spekol 1200, Germany) at 550 nm. Insulin. Timepoint: The blood sampling (8 mL) were collected after at -30 min, 0 min, 30 min, 60 min, 90 min, and after time trial performance. Method of measurement: The Roche Cobas insulin method (ROCHE Elecsys 2010, Roche Diagnostics, USA) was applied in this research to measure the insulin concentration which employs a biotinylated monoclonal insulin–specific antibody and a monoclonal insulin–specific antibody. Lactate. Timepoint: The blood sampling (8 mL) were collected after at -30 min, 0 min, 30 min, 60 min, 90 min, and after time trial performance. Method of measurement: The analysis of lactate was done by using commercial reagent kit (Cobas, USA)و by the auto-chemistry analyser (Roche Hitachi 912 Analyser, USA). Creatine Kinase. Timepoint: The blood sampling (8 mL) was collected after at -30 min, immediately after the time trial, and 24 hours after time trial performance. Method of measurement: N–acetyl–L–cysteine method (NAC) was used to measure the CK concentration by an auto analyser (Abbott Aeroset C–8000, USA) using a commercial kit (7D63–21, Creatine Kinase Reagent Kit). F2–Isoprostanes. Timepoint: The blood sampling (8 mL) was collected after at -30 min, immediately after the time trial, and 24 hours after time trial performance. Method of measurement: An enzyme immunoassay (EIA) was used to detect the presence of the F2-Isoprostanes (8-iso Prostaglandin F2α) in plasma by considering enzyme–linked immunosorbent assay (ELISA) method by a photometric microplate reader (Molecular Devices; Versamax Tunable Micro Plate Reader, USA). Ratings of Perceived Exertion. Timepoint: Every 15 min of the cycling. Method of measurement: Throughout the experimental trials, ratings of perceived exertion were obtained from the participants by the Borg’s Scale (Borg, 1998) which is a rating scale ranging among 6 to 20 to show the Ratings of Perceived Exertion. Respiratory Exchange Ratio. Timepoint: Every 15 min of the cycling. Method of measurement: The metabolic measurement system (SensorMedics™ VMax Spectra 29, USA) was used to determine respiratory exchange ratio. Core and Mean Skin Temperatures. Timepoint: Every 15 min of the cycling. Method of measurement: Libra Medical ET 300R temperature monitor (Libra Medical Corporation, USA) was used for continuous measurement of core temperature of the participants. To calculate the mean skin temperature, a formula (Ramanathan, 1964) was used. Sports Science Unit, School of Medical Sciences, Universiti Sains Malaysia Approved 2007-11-12 Ministry of Science, Technology and Innovation Malaysia Putrajaya, Malaysia Kuala Lumpur Kuala Lumpur Malaysia