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IRCT20160626028637N2 IRCT 2020-07-10 Tehran University of Medical Sciences The effect of turmeric-derived nanocorcumin supplementation on the amount of inflammation caused by adipose tissue in obese and overweight patients with migraine The effects of nano-curcumin supplementation on leptin, adiponectin gene expression and serum levels of some adipokines in obese and overweight patients with migraine. 2020-08-22 anticipated 44 Complete https://irct.ir/trial/49190 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified-Randomization method will be used in sampling to control sex and BMI variables.BMI will be considered as overweight (25-29/9) and obese (30 to 34.9) and sex will be considered as male and female, thus four lists including overweight female, obese female, overweight male and obese men will be considered.Then, patients will be divided equally into 2 groups by Permuted Block Randomization.Thus, randomly and using random table of numbers, 10 blocks of 2 consisting of different states (AB, BA, etc.) will be placed in each list and the order of treatment will be determined. Study groups are: nanocorcumin supplement group and the control group (group receiving placebo), Blinding description: Supplements are coded by a third person and given to participants in a same form package. None of the participants and researchers are aware of the allocation of groups. 3 Migraine. Intervention 1: Intervention group: Nano-curcumin receiver group, two 40 mg capsules per day Nano-curcumin after breakfast, for 2 months, made by Sina curcumin Iran. Intervention 2: Control group: Placebo receiver group, two capsules containing oral Pparaffin on the day after breakfast for 2 months, made by Sina curcumin Iran. Yes - There is a plan to make this available What will be shared: In addition to data on the main outcome of the study, the baseline data of participants (such as demographic and anthropometric data) will shared after blinding. When: The start of the data access period is 6 months after the publication of the results. To whom: The result of present study will be available to academic researcher and pharmaceutical companies in order to supplements production. Conditions: The data of the present study can be used for review, systematic review and meta-analysis study. Where to obtain: Applicants can access to study results trough e-mail address to a scientist responsible for the study: Mohsen Sedighiyan Email: m.sedighiyan86@gmail.com How to obtain: Through sites which the manuscript will indexed, through research gate site and send e-mail to scientist responsible for the study (Mohsen Sedighiyan) Comments:
public Mohsen Sedighiyan
No. 42, Hojat doost St., Naderi St. , Keshavarz Blv.
Tehran Iran (Islamic Republic of) 1417653911 +98 21 8895 5975 m.sedighiyan86@gmail.com Tehran University of Medical Sciences scientific Mohsen Sedighiyan
No. 42, Hojat doost St., Naderi St. , Keshavarz Blv.
Tehran Iran (Islamic Republic of) 1417653911 +98 21 8895 5975 m.sedighiyan86@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age = 20 to 50 (y) 25<= Body Mass Index (kg/m2) =< 35 Diagnosis of episodic migraine without aura, according to IHS criteria by neurologist Voluntary cooperation of patients 20 years 50 years Both use of dietary, vitamins and antioxidant supplements (such as curcumin) at least 4-6 weeks before the intervention Following special diets or special and intense physical activity at the last 3 months before the intervention Having comorbidity such as kidney disease, liver disease, pancreatitis, diabetes, cancer, thyroid disorders and inflammatory diseases, as well as patients with a history of heart attacks and strokes based on patient statements and medical history Pregnancy, lactation and menopause Alcohol consumption, cigarette smoking (at least 5 butts a day for the past 6 months), hookah, other types of tobacco and electronic types (VIP, anti-system) G43.0 Migraine without aura Treatment - Other Placebo Intervention group: Nano-curcumin receiver group, two 40 mg capsules per day Nano-curcumin after breakfast, for 2 months, made by Sina curcumin Iran Control group: Placebo receiver group, two capsules containing oral Pparaffin on the day after breakfast for 2 months, made by Sina curcumin Iran Leptin gene expression rate (percentage). Timepoint: The beginning and end of the study. Method of measurement: Real-Time Polymerase chain reaction method. Adiponectin gene expression rate (percentage). Timepoint: The beginning and end of the study. Method of measurement: Real-Time Polymerase chain reaction method. Leptin serum level. Timepoint: The beginning and end of the study. Method of measurement: Enzyme-linked immunosorbent assay. Adiponectin serum level. Timepoint: The beginning and end of the study. Method of measurement: Enzyme-linked immunosorbent assay. Resistin serum level. Timepoint: The beginning and end of the study. Method of measurement: Enzyme-linked immunosorbent assay. Visfatin serum level. Timepoint: The beginning and end of the study. Method of measurement: Enzyme-linked immunosorbent assay. MCP-1 serum level. Timepoint: The beginning and end of the study. Method of measurement: Enzyme-linked immunosorbent assay. Number of headache attacks. Timepoint: The beginning and end of the study. Method of measurement: Questionnaire. Headache duration. Timepoint: The beginning and end of the study. Method of measurement: Questionnaire. Headache severity. Timepoint: The beginning and end of the study. Method of measurement: Questionnaire. Sex. Timepoint: The beginning of study. Method of measurement: Questionnaire. Weight (kg). Timepoint: The beginning and end of study. Method of measurement: scale. Height (m). Timepoint: The beginning of study. Method of measurement: Height gauge. Body mass index (kg/m2). Timepoint: The beginning and end of study. Method of measurement: calculation. Waist circumference (cm). Timepoint: The beginning and end of study. Method of measurement: Meter tape. Total energy intake (kcal). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Protein intake (gr). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Carbohydrate intake (gr). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Fat intake (gr). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Cholesterol intake (mg/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Fiber intake (gr/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Turmeric intake (gr/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Vitamin D intake (ug/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Vitamin B12 intake (ug/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Omega 3 fatty acids intake (mg/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Folic acid intake (mg/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Vitamin B2 intake (mg/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Dietary total anti-oxidant intake (mg/d). Timepoint: The three dietary recall 24-hour questionnaires were taken at the beginning and end of the study and twice during the study, including two normal days and one day off (a total of 12 days). Method of measurement: Dietary recall 24-hour questionnaire. Physical activity level (MET per minute per week). Timepoint: The tow physical activity recall 24-hour questionnaires were taken at the beginning and end of the study. Method of measurement: physical activity recall 24-hour questionnaire. Stress level. Timepoint: The beginning and the end of study. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) short form. Anxiety level. Timepoint: The beginning and the end of study. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) short form. Depression level. Timepoint: The beginning and the end of study. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) short form. Migraine family history. Timepoint: The beginning of the study. Method of measurement: Ask the patient. The use of nonsteroidal anti-inflammatory drug. Timepoint: The end of the study. Method of measurement: Ask the patient. Tehran University of Medical Sciences Approved 2020-06-30 Ethics committee of School of Medicine- Tehran University of Medical Sciences Central building of Tehran University of medical Sciences. Blv. Keshavarz Tehran Tehran Iran (Islamic Republic of)