Protocol summary

Study aim
Determining the effect of 8 weeks of functional training on blood leptin levels in overweight and obese women Determining the effect of 8 weeks of functional training on body composition (percentage of fat, fat mass and lean mass) overweight and obese women Determining the effect of 8 weeks of chromium picolinate supplementation on blood leptin levels in overweight and obese women Determining the effect of 8 weeks of chromium picolinate supplementation on body composition (fat percentage, fat mass and lean mass) of overweight and obese women
Design
Quasi-experimental study with control group, with cross design, without blinding, random blocking method with 4 blocks and using random number table of random sequence software.
Settings and conduct
The distal training protocol is performed under the supervision of an instructor and in a gym and will include six types of hopping that will be performed for eight weeks and three 31-minute sessions each week. The intensity of the exercises is applied progressively by adding movements every week.
Participants/Inclusion and exclusion criteria
Admission requirements: Women 25 to 35 years old with a body mass index of 25 and above. Conditions of non-entry: Women who have had a regular exercise program in the past year, or are allergic to chromium supplements, or by a doctor Sports activities are prohibited or no conscious consent.
Intervention groups
Group1: Daily intake of chromium picolinate supplement (two doses of 200 micrograms) for eight weeks Group2: Performing functional exercises for 8 weeks Group3: Performing functional exercises and daily consumption of chromium picolinate supplement (two doses of 200 micrograms) for 8 weeks Fourth group (control): not receiving intervention or treatment to reduce the main consequences
Main outcome variables
Serum leptin, fat percentage, fat mass, lean mass

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220604055076N1
Registration date: 2022-06-13, 1401/03/23
Registration timing: prospective

Last update: 2022-06-13, 1401/03/23
Update count: 0
Registration date
2022-06-13, 1401/03/23
Registrant information
Name
shaghayegh akramiyh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 2509
Email address
shaghayegh.painting@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-11, 1401/04/20
Expected recruitment end date
2022-08-01, 1401/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of functional training and chromium picolinate supplementation on leptin levels and body composition of overweight and obese women
Public title
The effect of 8 weeks of functional training and chromium picolinate supplementation on leptin levels and body composition of overweight and obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight (body mass index 25 to 29.9) Obese (body mass index 30 and more) 25-35 years Female gender
Exclusion criteria:
Smoking Participate in regular sports activities for at least the past year Sensitivity to chromium supplementation Prohibition of exercise by a physician
Age
From 25 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
40 participants are randomly divided into 4 groups using a table of random numbers. In the present study, the restricted randomization method was used, which will be performed in a block randomization method.The size of four blocks is equal and we will have four groups of 40 blocks (including 10 people participating in each group). Randomization tool also uses software random allocation software (Random allocation software). In addition to simple randomization, these random sequence generation software are able to generate random sequences by block generation method. For concealment, we use concealment allocation, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences (envelopes opaque, sealed, numbered sequentially), in which each random sequence is recorded on a card. And the cards are placed in the envelopes of the letter, respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Science and Research Branch
Street address
Islamic Azad University, Science and Research Branch, shohada Hesarak Boulevard University Square, End of Shahid Sattari Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.IAU.SRB.REC.1400.299

Health conditions studied

1

Description of health condition studied
Serum leptin
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Physical composition
ICD-10 code
ICD-10 code description

3

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

Primary outcomes

1

Description
Serum leptin levels
Timepoint
One week before the first session (pre-test) and 24 hours after the last training session (post-test) in the eighth week
Method of measurement
ELISA method using Leptin ELISA kit by Mercodia

2

Description
Physical composition
Timepoint
One week before the first session (pre-test) and 24 hours after the last training session (post-test) in the eighth week
Method of measurement
Bioelectric impedance analysis method by bioelectric impedance device (Model / IOI353)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Daily intake of chromium picolinate supplement (two 200-microgram doses made by 21st Century USA after breakfast and dinner) for eight weeks
Category
Treatment - Other

2

Description
Intervention group2: Perform functional exercises for 8 weeks (including six types of hopping, which will last for eight weeks and three sessions of 31 minutes per week)
Category
Treatment - Other

3

Description
Intervention group3: Performing functional exercises and daily consumption of chromium picolinate supplement (two doses of 200 micrograms) for 8 weeks
Category
Treatment - Other

4

Description
Control group:not receiving intervention or treatment to reduce the main consequences
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sport Club
Full name of responsible person
Shaghayegh Akramiye
Street address
Islamic Azad University, Science and Research Branch, shohada Hesarak Boulevard University Square, End of Shahid Sattari Highway.
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
shaghayegh.painting@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed babak Mozafari
Street address
End of Shahid Sattari Highway - University Square - Shohada Hesarak Boulevard - Islamic Azad University, Science and Research Branch
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
Mozafari@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
50
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
Islamic Azad University
Full name of responsible person
Shaghayegh Akramiye
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Unit 6, No.16 ,Hamid Alley, North Eskandari St., Azadi St
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 6691 2509
Email
Shaghayegh.painting@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shaghayegh Akramiyh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Unit 6, No.16 ,Hamid Alley, North Eskandari St., Azadi St
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 6691 2509
Email
Shaghayegh.painting@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shaghayegh Akramiyh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
Unit 6, No.16 ,Hamid Alley, North Eskandari St., Azadi St
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 6691 2509
Email
Shaghayegh.painting@yahoo.com

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
Undecided - It is not yet known if there will be 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
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