Protocol summary

Study aim
The purpose of this study is to investigate the protective effect of high intensity interval training with spirulina supplement on cardiovascular metabolic risk factors of obese elderly women.
Design
A clinical trial with a control group, with parallel groups ( supplement plus training, placebo plus training, supplement and control), double-blind on 40 elderly people. A table of random numbers was used for randomization.
Settings and conduct
After selecting 40 obese elderly women who meet the conditions to enter and refer to the health centers of Birjand city and grouping people, for eight weeks, training groups have three exercise sessions with an intensity of 65 to 75% of the reserve heart rate and spirulina groups will also follow the daily intake of 1000 mg of the supplement. For double-blinding, before the start of the research, the packages containing the supplement and placebo will be marked by a person other than the researcher, and the consumption of the supplement and placebo will be done under the supervision of the same person.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range is 60-75 years BMI more than 25 kg/m2 Having general physical and mental health Inactive lifestyle Exclusion criteria: Using aids for walking Using the drug in the previous 6 months Having cardiovascular diseases
Intervention groups
Intervention group 1: training with spirulina, two 500 mg spirulina capsules daily and high intensity interval training 3 times a week Intervention group 2: spirulina, two 500 mg spirulina capsules daily Intervention group 3: training with placebo, two placebo capsules of 500 mg daily and high intensity interval training 3 times a week Control group: following daily activities without taking supplements and training
Main outcome variables
Angiopoietin-like factor-4, lipid profile

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220322054338N1
Registration date: 2024-02-07, 1402/11/18
Registration timing: prospective

Last update: 2024-02-07, 1402/11/18
Update count: 0
Registration date
2024-02-07, 1402/11/18
Registrant information
Name
elham ghasemi
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3123 2080
Email address
elhamghasemi@uoz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high intensity interval training with spirulina supplementation on cardiovascular metabolic risk factors and body composition of obese elderly women.
Public title
The effect of high intensity interval training and spirulina supplementation on cardiovascular metabolic risk factors and body composition of obese elderly women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range is 60-75 years BMI more than 25 kg/m2 Inactive lifestyle (exercise activity less than 1 hour per week) Having general physical and mental health
Exclusion criteria:
Using aids for walking Using the drug in the previous 6 months Having chronic diseases, especially cardiovascular diseases
Age
From 60 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The number of 40 elderly women volunteers eligible to participate in the study by non-probability sampling method (easy and accessible) and based on the purpose of selection and then randomly divided into four equal groups of supplement plus training, placebo plus training, supplement and control. A table of random numbers will be used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the supplement consuming groups will receive 2 capsules of 500 mg of spirulina in 2 times in the morning and in the evening for eight weeks (1000 mg of spirulina supplement per day), while in the placebo groups, 2 capsules containing starch will be taken daily. Before the start of the research, the cans with supplements and placebo will be marked by a person other than the researcher so that the researcher and participants are not informed about the type of capsules received. Supplement and placebo were taken under the supervision of the same person.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Sport Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-09-20, 1402/06/29
Ethics committee reference number
IR.SSRC.REC.1402.166

Health conditions studied

1

Description of health condition studied
Obese elderly
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Angiopoietin-like factor-4
Timepoint
The beginning and end of the study after 8 weeks
Method of measurement
ELISA

2

Description
Lipid profile
Timepoint
The beginning and end of the study after 8 weeks
Method of measurement
Biochemical and laboratory methods

Secondary outcomes

1

Description
Weight
Timepoint
The beginning and end of the study after 8 weeks
Method of measurement
digital scale

2

Description
Fat percentage
Timepoint
The beginning and end of the study after 8 weeks
Method of measurement
Body composition analysis device model IOI 353 made by South Korea Jawon Medical company.

Intervention groups

1

Description
Intervention group: training with spirulina, two 500 mg spirulina capsules daily and high intensity interval training 3 times a week for 8 weeks
Category
Treatment - Other

2

Description
Intervention group: spirulina, two 500 mg spirulina capsules daily for 8 weeks
Category
Treatment - Other

3

Description
Intervention group: training with placebo, two placebo capsules of 500 mg daily and high intensity interval training 3 times a week for 8 weeks
Category
Treatment - Other

4

Description
Control group: following daily activities without taking supplements and training for 8 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Zabol city
Full name of responsible person
Elham Ghasemi
Street address
Kilometer two of Bonjar road, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98613-35856
Phone
+98 54 3123 2082
Email
elhamghasemi@uoz.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Zabol
Full name of responsible person
Dr Majid Erfanian
Street address
Kilometer two of Bonjar road, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861335856
Phone
+98 54 3123 2045
Email
Resaffair@uoz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Zabol
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
University of Zabol
Full name of responsible person
Elham Ghasemi
Position
Assistant Professor of department of Sport Sciences, Facu
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Kilometer two of Bonjar road, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861335856
Phone
+98 56 3242 4947
Email
elhamghasemi@uoz.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Zabol
Full name of responsible person
Elham Ghasemi
Position
Assistant Professor of department of Sport Sciences, Faculty of Literature and Humanities, Universit
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Kilometer two of Bonjar road, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861335856
Phone
+98 56 3242 4947
Email
elhamghasemi@uoz.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Zabol
Full name of responsible person
Elham Ghasemi
Position
Assistant Professor of department of Sport Sciences, Faculty of Literature and Humanities, Universit
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Kilometer two of Bonjar road, Zabol
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861335856
Phone
+98 56 3242 4947
Email
elhamghasemi@uoz.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Subjects' information will be made available to other researchers after being de-identified
When the data will become available and for how long
After the publication of the final research report.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Citing the findings by citing the source
From where data/document is obtainable
Those interested in more information can contact the following email and address: Postal address: University of Zabol Email: elhamghasemi@uoz.ac.ir
What processes are involved for a request to access data/document
Send the request to the given postal address or email to Dr Elham Ghasemi and after the approval of the research team members, the data will be sent
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