Protocol summary

Study aim
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, plasma concentrations of glucose, insulin, free fatty acids, and lactate, F2-Isoprostanes, creatine kinase in the heat, as compared to placebo.
Design
The sample size of the current study was calculated by using PS Power and Sample Size Calculation v.2.1.30 (Dupont and Plummer Jr, 2010). In this research, a randomised single–blind, placebo–controlled cross–over trial was applied. The participants for this study were chosen randomly from the Kelantan cycling team. In this study 12 males selected as participants were moderately trained, heat–adapted cyclists. Heat–adaptation in these participants was obtained through existing regular training in a tropical environment (~31 °C; 70 % relative humidity). They have participated in local cycling competitions and were training regularly (three training sessions per week).
Settings and conduct
This study was done in Sports Science Unit, School of Medical Sciences, Health Campus, Universiti Sains Malaysia in Kota Bharu city.
Participants/Inclusion and exclusion criteria
between 15 – 30 years old, Non–smoker, Non–diabetic, Not using dietary supplements, two years of experience in cycling.
Intervention groups
There were four separate trials that were included: Sago-7.5% sago supplement Soy-7.5% soy supplement Sago+Soy-- 6%sago+1.5% soy supplement Placebo Therefore, each participant ingested one of them during each trial.
Main outcome variables
20-km time-trial, Plasma concentrations of glucose, free fatty acids, insulin, lactate, creatine kinase, f2-Isopostance, ratings of perceived exertion, respiratory exchange ratio, and skin and core temperatures.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190906044711N1
Registration date: 2020-08-03, 1399/05/13
Registration timing: retrospective

Last update: 2020-08-03, 1399/05/13
Update count: 0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Daniel Tarmast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5673 3125
Email address
danieltarmast@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2010-09-16, 1389/06/25
Expected recruitment end date
2013-04-09, 1392/01/20
Actual recruitment start date
2010-09-16, 1389/06/25
Actual recruitment end date
2013-04-09, 1392/01/20
Trial completion date
2013-04-09, 1392/01/20
Scientific title
EFFECTS OF COMBINED SAGO–SOY SUPPLEMENTATION ON CYCLING TIME TRIAL PERFORMANCE IN THE HEAT
Public title
Effect of Carbohydrate and Protein Ingestion in Exercise
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Age
From 15 years old to 30 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 15
Actual sample size reached: 12
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ministry of Science, Technology and Innovation Malaysia
Street address
Putrajaya, Malaysia
City
Kuala Lumpur
Postal code
62000
Approval date
2007-11-12, 1386/08/21
Ethics committee reference number
USM/0000814

Health conditions studied

1

Description of health condition studied
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
ICD-10 code
Y93.79
ICD-10 code description
Activity, other specified sports and athletics

Primary outcomes

1

Description
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.

2

Description
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).

3

Description
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.

4

Description
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.

5

Description
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).

6

Description
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).

7

Description
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).

8

Description
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.

9

Description
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.

10

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

3

Description
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.
Category
Treatment - Drugs

4

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sports Science Unit, School of Medical Sciences, Universiti Sains Malaysia (USM)
Full name of responsible person
Daniel Tarmast
Street address
Kubang Kerian
City
Kota Bharu
Postal code
16150
Phone
+60 9-767 7809
Fax
+60 9-767 7515
Email
danieltarmast@piau.ac.ir
Web page address
https://piau.ac.ir//?part=menu&inc=menu&id=1469

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sports Science Unit, School of Medical Sciences, Universiti Sains Malaysia
Full name of responsible person
Prof. Asok Kumar Ghosh
Street address
Kubang Kerian
City
Kota Bharu
Postal code
16150
Phone
+60 9-767 7809
Email
danieltarmast@gmail.com
Web page address
https://piau.ac.ir//?part=menu&inc=menu&id=1469
Grant name
e-Science Fund
Grant code / Reference number
USM/0000814
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sports Science Unit, School of Medical Sciences, Universiti Sains Malaysia
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
MY
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Daniel Tarmast
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Department of Physical Education & Sport Sciences, Faculty of Humanities, Parand Branch, Islamic Azad University
City
Tehran
Province
Tehran
Postal code
3761396361
Phone
+98 21 5673 3125
Fax
Email
danieltarmast@gmail.com
Web page address
https://piau.ac.ir//?part=menu&inc=menu&id=1469

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Daniel Tarmast
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Parand new city-Bahonar street
City
تهران
Province
Tehran
Postal code
3761396361
Phone
+98 938 941 9439
Email
danieltarmast@gmail.com
Web page address
https://piau.ac.ir//?part=menu&inc=menu&id=1469

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Daniel Tarmast
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Department of Physical Education & Sport Sciences, Faculty of Humanities, Parand Branch, Islamic Azad University
City
Tehran
Province
Tehran
Postal code
3761396361
Phone
+98 21 5673 3125
Fax
Email
danieltarmast@gmail.com
Web page address
https://piau.ac.ir//?part=menu&inc=menu&id=1469

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data of the current study belongs to the Universiti Sains Malaysia, and these data were collected for the Ministry of Science, Technology and Innovation Malaysia.
When the data will become available and for how long
By permission.
To whom data/document is available
Only available for people working in academic institutions.
Under which criteria data/document could be used
Additionally, for any athletic purposes.
From where data/document is obtainable
Sports Science Unit, School of Medical Sciences, Universiti Sains Malaysia (USM).
What processes are involved for a request to access data/document
Approximately, one month after a request the data will be discussed to either send or not. Then, 1 or 2 additional months will be available for the person who has requested.
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