Protocol summary

Study aim
Determining of the effects of curcumin supplementation along with pilates training on anthropometric indices, liver enzymes and lipid profile in overweight and obese women
Design
Clinical trial with control group, with factorial groups, single-blind, randomized, phase 3 on 60 people. For randomization, block design is used.
Settings and conduct
Referral to a private clinic in Ramsar in 2021, selection of 60 people based on inclusion criteria, randomization into 4 groups, intervention and pilates training for 8 weeks, completion of the individual consent, physical activity and 24-hour recall questionnaires, receiving 5 Cc of blood before and after the intervention. Blinding of statistical analyzer, coding by a third party who does not know the details.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study Women between 20 to 50 years old Body mass index (BMI) between 25 to 35 (kg / m2) Exclusion criteria: Reluctance of patients to participate in the study Use of other dietary supplements, probiotics and anti-inflammatory drugs Use of any antioxidant supplements in the last 3 months Use of immunosuppressive drugs Following of special diets Change of diet or decide to lose weight Pregnancy, lactation Smokers Menopause Metabolic and chronic diseases Having surgical operation to weight loss
Intervention groups
1) Supplement: one capsule 500 mg/d (450 mg of turmeric rhizome and 50 mg of turmeric extract), 2) Placebo: (one capsule 500 mg/d containing starch), 3) Pilates training (three times/week, 1 hour each time) and supplement one capsule 500 mg/d (450 mg of turmeric rhizome and 50 mg of turmeric extract), 4) Pilates training (three times/week, 1 hour each time) and placebo (one capsule 500 mg/d containing starch)
Main outcome variables
Liver enzymes, lipid profile and anthropometric indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210103049933N2
Registration date: 2021-05-24, 1400/03/03
Registration timing: registered_while_recruiting

Last update: 2021-05-24, 1400/03/03
Update count: 0
Registration date
2021-05-24, 1400/03/03
Registrant information
Name
zeinab porasgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5525 1015
Email address
porasgarizeynab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-24, 1400/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of curcumin supplementation along with pilates training on anthropometric indices, liver enzymes and lipid profile in overweight and obese women
Public title
The effects of curcumin supplementation along with pilates training in overweight and obese women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Women between 20 to 50 years old Body mass index (BMI) between 25 to 35 (kg / m2)
Exclusion criteria:
Reluctance of patients to participate in the study Use of other dietary supplements, probiotics and anti-inflammatory drugs Use of any antioxidant supplements in the last 3 months Use of immunosuppressive drugs Following of special diets Change of diet or decide to lose weight Pregnancy, lactation Smokers Menopause Having a history of diabetes, cancer, liver, kidney, thyroid and gastrointestinal diseases Having surgical operation to weight loss
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of people in each of the study groups (supplement, placebo, pilates training and supplement, pilates training and placebo) will be done by "Random allocation software" using classified randomized blocking method (block size: 4). In addition, in order to reduce selection bias error, allocation concealment will be used. This will be done by assigning unit codes (two codes A and B) to each person's capsules. In this way, 60 people will be randomly allocated to supplement (n = 15), placebo (n = 15), pilates training and supplement (15), pilates training and placebo (n = 15) groups. In fact, each person will receive a can containing code A or B, and eventually 30 people will receive cans containing code A and 30 people will receive cans containing code B. Also, 30 people in two groups will receive pilates training in addition to supplement or placebo.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, the statistical analyst will be blinded to the study groups. Before starting the study, the cans containing the respective capsules will be coded by a person other than the researcher (this person will not aware of the details of the research) to A and B, so that the type of received capsules in each group will be blinded for researcher. Also, placebo and supplement capsules will be similar in terms of color, shape, size and taste. In addition, cans containing the supplement and placebo will be quite similar.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Sport Sciences Research Institute
Street address
Velayat University Complex, Shahid Sohani St., Army Blvd, Imam Ali highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۱۴۸۹۶۳۵۳۷
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.SSRC.REC.1400.025

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
Weight
Timepoint
Before the intervention and 1 week after the end of intervention
Method of measurement
Seca scale

2

Description
Body mass index
Timepoint
Before the intervention and 1 week after the end of intervention
Method of measurement
Weight divided by the square of height in meters (kg / m2)

3

Description
Waist circumference
Timepoint
Before the intervention and 1 week after the end of intervention
Method of measurement
Tape metre (cm)

4

Description
Hip circumference
Timepoint
Before the intervention and 1 week after the end of intervention
Method of measurement
Tape metre (cm)

5

Description
Lipid profile (HDL-c, LDL-c, TG, total cholesterol and VLDL)
Timepoint
Before the intervention and 1 week after the end of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

6

Description
Alanine transaminase, Aspartate transaminase and Gamma-glutamyltransferase
Timepoint
Before the intervention and 1 week after the end of intervention
Method of measurement
Colorimetric enzymatic method (Pars Azmun)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:1) Supplement: one capsule 500 mg/d (450 mg of turmeric rhizome and 50 mg of turmeric extract) for 8 weeks
Category
Lifestyle

2

Description
Control group: one capsule 500 mg/d containing starch for 8 weeks
Category
Placebo

3

Description
Intervention group: 2) Pilates training (three times/week, 1 hour each time) and supplement one capsule 500 mg/d (450 mg of turmeric rhizome and 50 mg of turmeric extract) for 8 weeks
Category
Lifestyle

4

Description
Intervention group: 3) Pilates training (three times/week, 1 hour each time) and placebo (one capsule 500 mg/d containing starch) for 8 weeks
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
zeynab porasgari
Street address
No. 133, Mehregan Medical Building, Motahari St., Ramsar, Iran
City
Ramsar
Province
Mazandaran
Postal code
۴۶۹۱۸۴۶۹۴۰
Phone
+98 21 8807 4874
Email
porasgarizeynab@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Kashi
Street address
Tehran, Imam Ali highway, Army Blvd, Shahid Sohani St., Velayat University Complex
City
Tehran
Province
Tehran
Postal code
۱۱۴۸۹۶۳۵۳۷
Phone
+98 21 8807 4874
Email
porasgarizeynab@yahoo.com
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
1
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
zeynab porasgari
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Sports Physiology - Sports Nutrition
Street address
No.133, Mehregan Medical Building, Motahari St, Ramsar, Iran
City
Ramsar
Province
Mazandaran
Postal code
۴۶۹۱۸۴۶۹۴۰
Phone
+98 911 196 0775
Email
porasgarizeynab@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeynab Porasgari
Position
Master of Scienes
Latest degree
Master
Other areas of specialty/work
Sports Physiology - Sports Nutrition
Street address
No.133, Mehregan Medical Building, Motahari St, Ramsar, Iran
City
Ramsar
Province
Mazandaran
Postal code
۴۶۹۱۸۴۶۹۴۰
Phone
+98 911 196 0775
Email
porasgarizeynab@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zeynab Porasgari
Position
Master of Scienes
Latest degree
Master
Other areas of specialty/work
Sports Physiology - Sports Nutrition
Street address
No. 133, Mehregan Medical Building, Motahari St, Ramsar, Iran
City
Ramsar
Province
Mazandaran
Postal code
۴۶۹۱۸۴۶۹۴۰
Phone
+98 21 8807 4874
Email
porasgarizeynab@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The person's information will be confidential and the results will be as collective statistics
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This clinical trial will be an research article and its protocol, results report and statistical analysis will be published to be used by therapists and researchers.
When the data will become available and for how long
after the publication of results
To whom data/document is available
All researchers who have access to clinical trials databases
Under which criteria data/document could be used
Sometimes for re-analysis or for use in meta-analysis studies
From where data/document is obtainable
Project manager
What processes are involved for a request to access data/document
Mail to porasgarizeynab@yahoo.com
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