Protocol summary

Study aim
Investigating hedonic eating and its relation with some psychological characteristics and the effect of curcumin supplementation on serum levels of Anandamide and BDNF (Brain-Derived Neurotrophic Factor) and hedonic eating intensity in overweight and obese women
Design
In this double-blind clinical trial (both participants and researchers), patients visiting the nutrition specialist at Imam Reza Hospital will be randomly assigned to two groups. One group will receive oral curcumin supplementation, while the other group will receive an oral placebo capsule. Sleep quality will be compared between the two groups after eight weeks of intervention.
Settings and conduct
In this randomized double-blind clinical trial, participants in two study groups will receive either a 40 mg capsule of nano-micelle curcumin (with 100% encapsulation efficiency, equivalent to 0.8-2 grams of turmeric) or a placebo (containing a mixture of microcrystalline cellulose) with their lunch, for a duration of 8 weeks. Adherence to the intervention will be assessed by counting the number of capsules consumed.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study will consist of apparently healthy women with literacy skills, overweight and obese women, and women over the age of 18. The exclusion criteria will include postmenopausal women, pregnant or breastfeeding women, women with a recent history of weight loss or bariatric surgery, and women who have recently taken supplements or medications affecting sleep.
Intervention groups
In this study, patients who will visit the doctor due to obesity will be intervened. The patients will be randomly divided into two groups. One group will receive oral curcumin supplementation, while the other group will receive an oral placebo capsule. Sleep quality will be compared between the two groups after eight weeks.
Main outcome variables
Sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190325043107N53
Registration date: 2025-02-12, 1403/11/24
Registration timing: prospective

Last update: 2025-02-12, 1403/11/24
Update count: 0
Registration date
2025-02-12, 1403/11/24
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-17, 1403/11/29
Expected recruitment end date
2026-02-18, 1404/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating hedonic eating and its relation with some psychological characteristics and the effect of curcumin supplementation on serum levels of Anandamide and BDNF (Brain-Derived Neurotrophic Factor) and hedonic eating intensity in overweight and obese women
Public title
The Effect of Curcumin on Hedonic Eating, Anandamide, BDNF (Brain-Derived Neurotrophic Factor) and Psychological Factors in Overweight and Obese Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Apparently healthy women with literacy skills Overweight and obese women Women over 18 years old
Exclusion criteria:
Postmenopausal women Pregnant or breastfeeding women Women with a recent history of weight loss or bariatric surgery Women who have recently taken supplements or medications affecting sleep
Age
From 18 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 46, patients will be randomly allocated using the block permutation randomization method, which is employed to ensure balance in the number of participants allocated to each group. Six possible blocks are defined, each containing four participants: Block 1 (BBAA), Block 2 (AABB), Block 3 (ABAB), Block 4 (BABA), Block 5 (ABBA), and Block 6 (BAAB). To allocate participants, 12 blocks are needed for 46 individuals. These blocks are generated using the Random Allocation Software, which can create random sequences using the block randomization method. Numbers from 1 to 6 are randomly selected, and for example, if block 6 is selected first and block 2 second, the sequence BAABAABB will be assigned to the participants as they enter the study, from left to right. In the end, participants will be divided into two groups: the intervention group (Group A) and the control group (Group B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The principal investigator and participants will remain unaware of the procedure being performed and will be blinded throughout the study; therefore, this study will be conducted as a double-blind trial. Since participants will be unaware of the type of drug being used, they will not know what type of medication is being administered to other patients in the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2024-12-01, 1403/09/11
Ethics committee reference number
IR.TBZMED.REC.1403.793

Health conditions studied

1

Description of health condition studied
Sleep quality
ICD-10 code
F15.282
ICD-10 code description
Other stimulant dependence with stimulant-induced sleep disorder

Primary outcomes

1

Description
Sleep quality
Timepoint
Twice, before and after the intervention (after eight weeks).
Method of measurement
Using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.

2

Description
Hedonic eating
Timepoint
Twice, before and after the intervention (after eight weeks).
Method of measurement
Using the Power of Food Scale (PFS).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this randomized double-blind clinical trial, participants in the intervention group will receive a 40 mg capsule of nano-micelle curcumin (with 100% encapsulation efficiency, equivalent to 0.8-2 grams of turmeric) with their lunch, for a duration of 8 weeks. Adherence will be assessed by counting the number of capsules consumed. Before the intervention begins and after 8 weeks of supplement or placebo consumption, sleep quality and hedonic eating will be measured.
Category
Treatment - Drugs

2

Description
Control group: In this randomized double-blind clinical trial, participants in the intervention group will receive a placebo capsule (containing a mixture of microcrystalline cellulose) with their lunch, for a duration of 8 weeks. Adherence will be assessed by counting the number of capsules consumed. Before the intervention begins and after 8 weeks of supplement or placebo consumption, sleep quality and hedonic eating will be measured.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Reza Mahdavi
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
6165665631
Phone
+98 21 3335 5921
Email
mkhanbabayi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
shahabip@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Azadeh Khalili
Position
PhD candidat in Nutritional Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azadeh Khalili
Position
PhD Candidate in Nutritional Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.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
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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