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Determining the effect of 8 weeks of resistance training and spirulina supplementation on levels of asprosin, Glucose, lipid profile and some body composition indices in overweight men

Protocol summary

Study aim
Determining the effect of 8 weeks of resistance training with spirulina on aspirin, glucose, lipid profile and body composition indices of overweight men
Design
Clinical trial with intervention and control groups, Single blind, randomised, Over 60 overweight man, G-Power software medicine is used for randomization.
Settings and conduct
Overweight men who refer to the gyms of Zahedan University of Medical Sciences will be included in the study if they have inclusion criteria, and randomly will be assigned into two groups of intervention and two groups of control applying the permuted block method. This study will be single blind so that participants will not be aware of the contents of the capsules since they may think the capsules contain spirulina.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 50-30 years old, General physical and mental health, Body mass index more than 25 kg/m2. Exclusion criteria: having exercised regularly during 6 months before the start of training sessions, suffering from cardiovascular diseases, diabetes, hormonal disorders, kidney, or liver diseases, Being a smoker, having recently had any surgery or medical interventions
Intervention groups
Intervention group 1: Exercise with spirulina, two spirulina capsules 500 mg daily (Made by Reyhaneh Pharmaceutical Company of Isfahan) for 8 weeks and resistance training 3 sessions per week for 8 weeks. Intervention group 2: Spirulina, two capsules of Spirulina 500 mg daily (Made by Reyhaneh Pharmaceutical Company of Isfahan) for 8 weeks. Control group 1: Placebo exercise, two placebo capsules 500 mg daily (Made by Reyhaneh Pharmaceutical Company of Isfahan) for 8 weeks and resistance training 3 sessions per week for 8 weeks. Control group 2: placebo, two placebo capsules 500 mg daily (Made by Reyhaneh Pharmaceutical Company of Isfahan) for 8 weeks.
Main outcome variables
levels of asprosin, Glucose, lipid profile

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160813029322N4
Registration date: 2021-11-09, 1400/08/18
Registration timing: retrospective

Last update: 2021-11-09, 1400/08/18
Update count: 0
Registration date
2021-11-09, 1400/08/18
Registrant information
Name
Hossein Nakhei
Name of organization / entity
University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 1374
Email address
h.nakhaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of 8 weeks of resistance training and spirulina supplementation on levels of asprosin, Glucose, lipid profile and some body composition indices in overweight men
Public title
The effect of exercise and spirulina supplementation on the Asprosin hormone in overweight men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 50-30 years old General physical and mental health Body mass index (BMI) more than 25 kg / m 2
Exclusion criteria:
If the participant has exercised regularly during 6 months before the start of training sessions If the participant has suffers from cardiovascular diseases If the participant has suffers from diabetes disease If the participant has suffers from hormonal disorders disease If the participant has suffers from kidney disease If the participant has suffers from liver disease If the participant is a smoker If the participant has recently had any surgery or medical interventions
Age
From 30 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Out of all the population, a number of 60 overweight men will be selected using G-Power software. Individuals will be divided into four groups by the permuted block method with blocks size 4 as A: placebo, B: spirulina with training, C: training with placebo, and D: spirulina
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a single blind, clinical trial study. It is single blind in spirulina and placebo groups. The subjects will study the research protocol in the first session. The supplement and placebo will be in the same capsules. The capsules will be distributed among the participants. Only the researcher knows the contents of the capsules.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
university/regional research Ethics committee Zahedan University of medical sciences
Street address
Medical Sciences Campus- Dr. Hesabi Square- Zahedan City- Sistan and Baluchestan Province
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.ZAUMS.REC.1400.056

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Asprosin
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Plasma Asprosin levels were measured using an ELISA kit (Zell Bio Co made in Germany with a sensitivity of 0.05 ng/m), and ELISA-by-ELISA Reader (US lotion model).

2

Description
Glucose
Timepoint
Before the intervention and two months after the intervention
Method of measurement
ParsAzmon Kit (mg/dl)

3

Description
triglyceride
Timepoint
Before the intervention and two months after the intervention
Method of measurement
ParsAzmon Kit (mg/dl)

4

Description
Cholesterol
Timepoint
Before the intervention and two months after the intervention
Method of measurement
ParsAzmon Kit (mg/dl)

5

Description
High Density Lipoprotein
Timepoint
Before the intervention and two months after the intervention
Method of measurement
ParsAzmon Kit (mg/dl)

6

Description
Low Density Lipoprotein
Timepoint
Before the intervention and two months after the intervention
Method of measurement
ParsAzmon Kit (mg/dl)

Secondary outcomes

1

Description
Least body mass
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Body composition analyzer, model IOI 353, made by Jawon Medical, South Korea.

2

Description
Lean body mass
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Body composition analyzer, model IOI 353, made by Jawon Medical, South Korea.

3

Description
Waist to height ratio
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Height will be measured with Sahand Company's height meter and Waist circumference will be measured with a Tape meter (made in Iran).

Intervention groups

1

Description
Intervention group 1: Training with spirulina: Spirulina group will take two 500 mg spirulina capsules daily (morning and evening) for eight weeks. Rayhaneh Pharmaceutical Company of Isfahan will provide Spirulina supplement. Resistance training will be implemented for eight weeks, 3 sessions each week, and in 12 movements with 1, 2, 3, and 4-minute rest intervals, and 40, 60, 75, and 90 percent of a maximum repetition, using a flexible scheduling pattern, and an additional principle. Exercises will be performed in a gym in Zahedan.
Category
Rehabilitation

2

Description
Intervention group 2: spirulina. Spirulina group will take two 500 mg spirulina capsules daily (morning and evening) for eight weeks. Rayhaneh Pharmaceutical Company of Isfahan will provide Spirulina supplement.
Category
Treatment - Drugs

3

Description
Control group 1: Training With placebo. The placebo group will take two 500 mg capsules of starch daily for eight weeks. The placebo will be provided by Reyhaneh Pharmaceutical Company of Isfahan. Resistance training will be implemented for eight weeks, 3 sessions each week, and in 12 movements with 1, 2, 3, and 4-minute rest intervals, and 40, 60, 75, and 90 percent of a maximum repetition, using a flexible scheduling pattern, and an additional principle. Exercises will be performed in a gym in Zahedan.
Category
Rehabilitation

4

Description
Control group 2: Placebo. The placebo group will take two 500 mg capsules of starch daily for eight weeks. The placebo will be provided by Reyhaneh Pharmaceutical Company of Isfahan.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Sports Hall, Zahedan University of Medical Sciences
Full name of responsible person
Hossein Nakhaei
Street address
Velayat Sports Hall- Main campus- Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
dsc@zaums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Nour Mohammad Bakhshani
Street address
Vice chancellor of researches and technology- Main campus- Dr. Hessabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2117
Fax
+98 54 3337 2117
Email
zaums.research@gmail.com
Web page address
http://research.zaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hossein Nakhaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Main campus, Dr. Hassabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
hossiennakhaie@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hossein Nakhaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Main campus, Dr. Hessabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
hossiennakhaie@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hossein Nakhaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Main campus, Dr. Hessabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
hossiennakhaie@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data including: (IPD), study protocol, statistical analysis map, informed consent form, clinical study report and data dictionary will be published upon completion of the study. Participants' identities will not be released.
When the data will become available and for how long
Data will be available immediately upon completion of the project. It will probably be released in 1401.
To whom data/document is available
For researchers of academic and scientific institutions
Under which criteria data/document could be used
For the development of related sciences
From where data/document is obtainable
Refer to Zahedan University of Medical Sciences by letter
What processes are involved for a request to access data/document
Submit a valid letter from the scientific centres
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