Semi-experimental with a non-blinded design, 40 volunteers were selected from elderly and inactive women and after filling out the consent form and the health and disease risk questionnaire, they were randomly divided into four groups: control-supplement-exercise and exercise+supplement. The intervention was eight weeks. The training and exercise+supplement group had eight weeks of resistance training in water (three sessions a week, each session for one hour), and the supplement and exercise+supplement groups had 30 grams of dark chocolate daily (6 pieces of 83% dark chocolate, 5 grams ) they received. The control group also did not have any sports activities or supplements during this period. Blood samples were taken 48 hours before and after the intervention.
Settings and conduct
Semi-experimental and unblinded and in the field of providing health services - Sarai Mahaleh and Center for the Elderly in the 8th district of Tehran
Participants/Inclusion and exclusion criteria
Entry requirements: 60-73 years old and inactive (not participating in regular sports activities in the last 12 months)
Non-entry conditions: Chronic lung disease, ischemic heart disease, valvular heart disease - hypertrophic heart failure - smoking - mental and psychological diseases such as dementia, muscle and joint injuries such as lumbar disc protrusion
Intervention groups
1-control group, 2-supplement group, 3-exercise group, 4-exercise+supplement group
Main outcome variables
Serum levels GDF8,GDF11, ActRIIB and GASP-1
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20240519061840N1
Registration date:2024-06-11, 1403/03/22
Registration timing:registered_while_recruiting
Last update:2024-06-11, 1403/03/22
Update count:0
Registration date
2024-06-11, 1403/03/22
Registrant information
Name
Maryam Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4432 9092
Email address
maryam.mousavi@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-16, 1403/02/27
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
2024-05-16, 1403/02/27
Actual recruitment end date
2024-07-18, 1403/04/28
Trial completion date
2024-07-18, 1403/04/28
Scientific title
The effect of eight weeks water resistance training with consumption of dark chocolate on the changes of GDF8, GDF11, ActRIIB, GASP-1 in elderly women
Public title
Investigating the effect of water resistance training and dark chocolate supplementation on On the effective factors in sarcopenia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Seniors 60-73 years old and inactive (not participating in regular sports activities in the last 12 months)
Exclusion criteria:
Specific diseases such as chronic lung disease - ischemic heart disease - Valvular heart disease - hypertrophic heart failure - smoking - mental and psychological diseases (such as dementia) muscle and joint injuries (such as lumbar disc protrusion)
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Simple - by using a table of random numbers - in such a way that by numbering people from 0 to 40, the first number we find is placed in the first intervention group: the control group, the second number in the second intervention group: the supplementary group, the third number In the third intervention group: the exercise group, and the fourth number is placed in the fourth intervention group, i.e. the supplement + exercise group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The exercise protocol was designed by the researcher and supervisor and is a pilot study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University - Tehran Science and Research Unit
Street address
Tehran - the end of Shahid Sattari Highway - University Square - Shahadai Hesarak Blvd - Islamic Azad University, Science and Research Unit
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2024-05-15, 1403/02/26
Ethics committee reference number
IR.IAU.SRB.REC.1403.088
Health conditions studied
1
Description of health condition studied
The relationship between eight weeks of resistance training in water and consumption of dark chocolate on factors related to sarcopenia in elderly women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
GDF8
Timepoint
48 hours before the start of the intervention and after the end of the eight weeks of the intervention
Method of measurement
by Realtime -PCR method
2
Description
GDF11
Timepoint
48 hours before the start of the intervention and after the end of the eight weeks of the intervention
Method of measurement
by Realtime -PCR method
3
Description
Activin Reseptor IIβ
Timepoint
48 hours before the start of the intervention and after the end of the eight weeks of the intervention
Method of measurement
by Realtime -PCR method
4
Description
GASP-1
Timepoint
48 hours before the start of the intervention and after the end of the eight weeks of the intervention
Method of measurement
by Realtime -PCR method
Secondary outcomes
1
Description
water Resistance training
Timepoint
before the start of the intervention and after the completion of eight weeks of the intervention
Method of measurement
It is measured by the level of perception of the RPE effort.
Intervention groups
1
Description
Intervention group 1: Control group: The subjects of this group did not have any sports activities or supplement consumption during this period of eight weeks and continued their normal life.
Category
Other
2
Description
Intervention group 2: Supplemental group: The subjects of this group did not do any sports activities and received only 30 grams of dark chocolate (6 pieces of 83% dark chocolate, 5 grams) daily for eight weeks.
Category
Other
3
Description
Intervention group 3: Exercise group: The subjects of this group did resistance training in water for eight weeks (three sessions a week, each session for one hour).
Category
Other
4
Description
Intervention group 4: exercise + supplement group: the subjects of this group did resistance training in water for eight weeks (three sessions a week, each session for one hour) and during these eight weeks, 30 grams of dark chocolate (6 pieces of 83% dark chocolate) , 5 grams) received.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarai Mahleh and the center of worldviewers in the 8th district of Tehran
Full name of responsible person
maryam mousavi
Street address
Tehranpars - Damavand St. - Shahid Maleki St
City
Tehran
Province
Tehran
Postal code
1651967441
Phone
+98 21 7792 5052
Email
mousavi.maryam745@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryam mousavi
Street address
Tehran - the end of Shahid Sattari Highway - University Square - Shahadai Hesarek Blvd - Islamic Azad University of Science and Research Branch of Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 912 608 2068
Email
mousavi.maryam745@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryam mousavi
Position
Ph.D. student, Sports Physiology, Islamic Azad University, Science and Research Branch, Tehran
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Tehran - the end of Shahid Sattari Highway - University Square - Shahadai Hesarek Blvd - Islamic Azad University of Science and Research Branch of Tehran
City
تهران
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 8495
Email
mousavi.maryam745@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Ghazalian
Position
Associate Professor, Department of Sports Physiology, Islamic Azad University, Science and Research
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Tehran - the end of Shahid Sattari Highway - University Square - Shahadai Hesarek Blvd - Islamic Azad University of Science and Research Branch of Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 8495
Email
phdghazalian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Mousavi
Position
Ph.D. student, Sports Physiology from Islamic Azad University, Faculty of Science and Research Branc
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Tehran - the end of Shahid Sattari Highway - University Square - Shahadai Hesarek Blvd - Islamic Azad University of Science and Research Branch of Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 8495
Email
mousavi.maryam745@gmail.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as information on the main outcome
When the data will become available and for how long
After printing the article
To whom data/document is available
For readers in the magazine
Under which criteria data/document could be used
With the permission and discretion of the researcher
From where data/document is obtainable
Cite the article published in the journal
What processes are involved for a request to access data/document