Protocol summary

Summary
The purpose of this study is to investigate the effect of eight weeks resistance training, Epicatechin supplementation and the combined effect of these two interventions on plasma levels of Myostatin and Follistatin in sarcopenic older adults. The present study is semi-experimental and developmental with pre-test and post-test design. Inclusion criteria consist of sarcopenic, non-athletic elderly males aged 65-75 years and exclusion criteria consist of the history of special diseases and the use of any type of drug or supplement. A week prior to the initial tests, all participants will attend an orientation session in which they will be informed about the objectives and methods of conducting the research by exercise science specialists. Initial tests will be performed in the morning a week before the study to select qualified people and homogenize groups. Their height, weight, body mass index, AMMI, mobility, the degree of involvement in physical activities, health condition, and isotonic maximal strength will be measured and 56 subjects randomly will assign to 4 groups (using the table of random numbers method): resistance training+placebo (n=13), resistance training+epicatechin (n=14), epicatechin (n=15) and placebo (n=14). Forty-eight hours before the 8-week intervention, fasting blood samples will be taken from participants’ arm vein to evaluate the study variables. Then, subjects of the training groups will perform the training protocol 3 days a week at 5 p.m. for eight weeks. During the same time, individuals in the supplement groups will take epicatechin supplements at 4 p.m. every day (1mg/kg/day). In order to control the psychological effects of taking the supplement, members of the placebo group will receive placebo capsules (starch) which are similar to the epicatechin capsules in terms of shape and color. The subjects of the placebo group will not participate in any exercise training during the intervention time. Fasting blood samples will be obtained from all the participants two days following the last training session (hence, posttest).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017101423002N4
Registration date: 2017-10-31, 1396/08/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-31, 1396/08/09
Registrant information
Name
Alireza Ghardashi Afousi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8201 5031
Email address
ghardashi.a@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2017-04-08, 1396/01/19
Expected recruitment end date
2017-06-01, 1396/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Improvement of muscle strength and circulatory levels of plasma Follistatin and Myostatin following resistance training and Epicatechin supplementation in sarcopenic older adults
Public title
Effect of resistance training and Epicatechin on Sarcopenia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: males between the age of 65-75 years; suffering from class I sarcopenia (AMMI: less than 10.75 kg.m-2); and having no training experiences over the past 12 months before the study. Exclusion criteria: having a history of specific diseases (e.g. valvular heart disease (VHD), ischemic heart disease (IHD); chronic lung disease (COLD); hypertrophic cardiomyopathy (HCM); hyperlipoproteinemia (HLP); hypertension (HTN)); unwillingness to participate in the study; smoking; using supplements or drugs over the past month before the study; suffering from psychological diseases (e.g. mental disorder); and suffering from muscle and joint injuries (e.g. slip disk in the back).
Age
From 65 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Tehran
Street address
16th Azar Street, Enghelab Square, Central Organization of University of Tehran
City
Tehran
Postal code
Approval date
2017-02-16, 1395/11/28
Ethics committee reference number
IR.UT.Rec.1395010

Health conditions studied

1

Description of health condition studied
Sarcopenia
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Follistatin
Timepoint
Before starting the intervention, after eight weeks intervention
Method of measurement
Blood sample, ELISA method with special kit

2

Description
Myostatin
Timepoint
Before starting the intervention, after eight weeks intervention
Method of measurement
Blood sample, ELISA method with special kit

Secondary outcomes

1

Description
BMI
Timepoint
Before and after the intervention
Method of measurement
weight(kg) / height to the power of 2 (cm)

2

Description
AMMI
Timepoint
Before and after the intervention
Method of measurement
DXA

3

Description
up and go test
Timepoint
Before and after the intervention
Method of measurement
measuring the test time

4

Description
physical activities rate
Timepoint
Before and after the intervention
Method of measurement
Via The Physical Activity Scale for the Elderly questionnaire /PASE

5

Description
physical health condition
Timepoint
Before and after the intervention
Method of measurement
using PAR-Q questionnaire

6

Description
Maximal Strength
Timepoint
Before and after the intervention
Method of measurement
1RM test

Intervention groups

1

Description
Exercise+Placebo group: participants of this group performed 8 weeks resistance training (at 5 to 6 p.m., three sessions per week, each session took approximately 60 minutes, with 60-80% of one repetition maximum). In addition, during this 8-week period this group received one capsule similar to Epicatechin capsules (in terms of color and shape) with 200 ml water daily, at the same time as the supplement group (one hour before doing resistance training, at 4 p.m.).
Category
Placebo

2

Description
Placebo group: participants of this group will receive one capsule similar to Epicatechin capsules (in terms of smell and shape) daily with 200 ml water for 8 weeks, at the same time as the supplement group (at 4 p.m.).
Category
Placebo

3

Description
Exercise+supplement group: participants of this group performed 8 weeks resistance training (at 5 to 6 p.m., three sessions per week, each session took approximately 60 minutes, with 60-80% of one repetition maximum). In addition, during this 8-week period this group consumed one Epicatechin capsule daily (1 mg/kg/day), with 200 ml water, one hour before doing resistance training (at 4 p.m.).
Category
Other

4

Description
Supplement group: participants of this group consumed one Epicatechin capsule daily (1mg/kg/day) with 200 ml water, at 4 p.m. for 8 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Street address
Faculty of Physical Education and Sport Sciences, after the intersection of Jalal Al Ahmad, between 15th and 16th Street, North Kargar Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Alireza Ghardashi Afousi
Street address
Faculty of Physical Education and Sport Sciences, after the intersection of Jalal Al Ahmad, between 15th and 16th Street, North Kargar Street
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Position
PhD student of exercise physiology
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Sciences, after the intersection of Jalal Al Ahmad, between 15th and 16th Street, North Kargar Street
City
Tehran
Postal code
Phone
+98 21 8835 1740
Fax
Email
ghardashi.a@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Abbasali Gaeini
Position
University of Tehran Professor
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Sciences, after the intersection of Jalal Al Ahmad, between 15th and 16th Street, North Kargar Street
City
Tehran
Postal code
Phone
+98 21 8835 1740
Fax
Email
aagaeini@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi Afousi
Position
PhD student of exercise physiology
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Sciences, after the intersection of Jalal Al Ahmad, between 15th and 16th Street, North Kargar Street
City
Tehran
Postal code
Phone
+98 21 8835 1740
Fax
Email
ghardashi.a@ut.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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