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IRCT20080904001197N22 IRCT 2023-06-21 Tabriz University of Medical Sciences Investigating the effect of melatonin supplementation in obesity Investigating the effect of melatonin supplementation on plasma levels of ghrelin, 2-arachidonoylglycerol and hedonic eating intensity 2024-02-04 anticipated 46 Complete https://irct.ir/trial/70034 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects will be randomly allocated to either the melatonin or placebo groups in a 1:1 ratio using the Random Allocation Software (RAS), through the Stratified Blocked Randomization method (in blocks of 2) stratified by BMI (< 30 kg/m2 or ≥ 30 kg/m2) as the possible confounding factor, Blinding description: To conduct a double-blind study, at the beginning of the study, the packages containing melatonin and placebo supplements will be coded as A and B by a person not involved in the study (to blind the researcher). Also, the supplement and placebo pills will be identical in terms of color, shape, smell and appearance (to blind the participant). N/A Overweight and Obesity. Intervention 1: Intervention group: Participants in this group will take a 5 mg melatonin tablet one hour before going to bed at night with enough water for 8 weeks. Intervention 2: Control group: Participants in this group will take a 5 mg placebo tablet (combination of silicon dioxide, cellulose and starch) one hour before going to bed at night with enough water, for 8 weeks. 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 further information.
public Malihe Karamizadeh
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 malihekarami1370@gmail.com Tabriz University of Medical Sciences scientific Dr. Reza Mahdavi
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7580 mahdavir@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Apparently healthy women volunteers Literate 19-49 years BMI=25-34.9 kg/m2 Having high hedonic eating intensity Unwillingness to diet Desire to use drugs or supplements to lose weight 19 years 49 years Female Postmenopausal, pregnant or lactating women Recent weight loss or participation in weight loss programs Suffering from binge eating Current smokers Recent history of taking supplements affecting appetite (in the last 3 months) Women who, according to themselves, are suffering from substance abuse, alcohol addiction, certain diseases such as cancer, heart disease and diabetes Women who, according to themselves, have hypothyroidism and use medicine for this purpose Women who, according to themselves, use drugs that affect appetite, such as antidepressants, steroids, and contraceptives Having night shifts Having severe insomnia or thyroid disorders Using drugs that interfere with melatonin (anti-hypertensive drugs, anticonvulsant drugs, beta blockers, anticoagulant drugs, sedatives, antidepressants, oral contraceptive pill, corticosteroids) Melatonin supplementation intolerance during the study Using less than 90% melatonin supplements or placebo E66.9 Obesity, unspecified Treatment - Other N/A Intervention group: Participants in this group will take a 5 mg melatonin tablet one hour before going to bed at night with enough water for 8 weeks. Control group: Participants in this group will take a 5 mg placebo tablet (combination of silicon dioxide, cellulose and starch) one hour before going to bed at night with enough water, for 8 weeks. Plasma level of acyl ghrelin. Timepoint: Before starting and at the end of the study. Method of measurement: ELISA. Plasma level of 2-arachidonylglycerol. Timepoint: Before starting and at the end of the study. Method of measurement: ELISA. Hedonic eating score. Timepoint: The first phase of the study and at the end of the study. Method of measurement: Power of food scale. Total energy intake. Timepoint: Before the start of the study, after 4 weeks, and at the end of the study. Method of measurement: 3-day food recall. Energy intake from macronutrients. Timepoint: Before the start of the study, after 4 weeks, and at the end of the study. Method of measurement: 3-day food recall. Weight. Timepoint: Before the start of the study, after 4 weeks, and at the end of the study. Method of measurement: Scale. Tabriz University of Medical Sciences Approved 2023-04-17 Research Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Daneshgah street Tabriz East Azarbaijan Iran (Islamic Republic of)