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IRCT20190325043107N53 IRCT 2025-02-12 Tabriz University of Medical Sciences The Effect of Curcumin on Hedonic Eating, Anandamide, BDNF (Brain-Derived Neurotrophic Factor) and Psychological Factors in Overweight and Obese Women 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 2025-02-17 anticipated 46 Complete https://irct.ir/trial/81533 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 2-3 Sleep quality. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no additional information.
public Azadeh Khalili
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Azadeh Khalili
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Apparently healthy women with literacy skills Overweight and obese women Women over 18 years old 18 years 65 years Female 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 F15.282 Other stimulant dependence with stimulant-induced sleep disorder Treatment - Drugs Placebo 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. 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. Sleep quality. Timepoint: Twice, before and after the intervention (after eight weeks). Method of measurement: Using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Hedonic eating. Timepoint: Twice, before and after the intervention (after eight weeks). Method of measurement: Using the Power of Food Scale (PFS). Tabriz University of Medical Sciences Approved 2024-12-01 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)