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IRCT20150120020737N2 IRCT 2019-10-04 Shiraz University of Medical Sciences flax seed oil in metabolic syndrome Comparing the effects of flax seed oil vs. sunflower oil consumption on interleukin-6, total antioxidant capacity, and blood coagulation times in metabolic syndrome patients 2017-04-14 anticipated 60 Complete https://irct.ir/trial/42226 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization was performed. The four blocks were selected and the men and women were divided equally into groups. 3 metabolic syndome. Intervention 1: Intervention group: Flax seed oil was prepared and packaged by a cold press machine. People add 25 cc of flaxseed oil daily to cold foods and consume for 7 weeks. A measuring spoon was provided to facilitate measurement by the participants. Intervention 2: Control group: sunflower seed oil was prepared and packaged by a cold press machine. People add 25 cc of sunflower seed oil daily to cold foods and consume for 7 weeks. A measuring spoon was provided to facilitate measurement by the participants. Yes - There is a plan to make this available What will be shared: Primary outcome data can be shared after unidentifiable. When: Access started in 1399 To whom: Academics and industry people Conditions: No special conditions Where to obtain: Person in charge Atefeh Akrami Akramiat@sums.ac.ir How to obtain: One week after receiving the request by email Comments:
public Atefeh Akrami
University of nutrition and food science, Razi Blvd.
Shiraz Iran (Islamic Republic of) 71348- 14336 +98 71 3725 7288 akramiat@sums.ac.ir Shiraz University of Medical Sciences scientific Siavash Babajafari
University of nutrition and food science, Razi Blvd.
Shiraz Iran (Islamic Republic of) 71348- 14336 +98 71 3725 7288 jafaris@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) protocol have three or more of the five listed:Abdominal obesity (waist circumference greater than or equal to 102 cm in men and greater than or equal to 88 cm in women)Low HDL-C levels (less than 40 mg / dL in men and less than 50 mg / dL in women)۳ High serum triglyceride level (mg / dL۱۵۰≥)۴ (high blood pressure (130/85 mmHg)) or under hypertension treatment5) impaired glucose homeostasis (110≥F fasting blood glucose level) 30 years 60 years Both Exclusion criteria include:A history of allergies and allergies to sunflower or seed or two or more types of nuts and seeds,Thyroid diseases (uncontrolled hyperthyroidism),Liver disease (obstruction or biliary disease), liver malformations,Alcoholism, smoking,Autoimmune diseases,Chronic pancreatitis,Kidney problems Nephritic syndrome or kidney disorders (increased blood creatinine more than 1.5 mg / dl),Digestive problems,Simultaneous presence in other clinical trials,Aspirin or any NSAID, propranolol, heparin, warfarin and antiplatelet use (such as Plavix)The presence of any infection or any infectious disease at the beginning or during the study, diabetic foot ulcer,Insulin, Multivitamins and Omega-3 supplements over the past 3 months, any steroids,High blood lipids or medications such as all types of blood lipid lowering agents (statins, gemfibrozil, niacin, lipase inhibitors) or physician discontinuation of blood lipid lowering drugs (at triglyceride levels less than 400 and LDL-C levels lower). Of 170)Hypoglycemic agents are not harmful if used during the past three months and continued during the study. Provided that the dose of the drug is not changed during the study.Also, people with a history of myocardial infarction or angioplasty or any non-outpatient surgery during the 6 months prior to the study,Pregnant and suspected pregnant or lactating women will not be allowed to enter the study.Exclusion criteria: These include: starting taking any of the above mentioned drugs and lipid lowering medications or changing the dosage of the drug, causing allergies or any discomfort with the intervention E88.9 Metabolic disorder, unspecified Other Other Intervention group: Flax seed oil was prepared and packaged by a cold press machine. People add 25 cc of flaxseed oil daily to cold foods and consume for 7 weeks. A measuring spoon was provided to facilitate measurement by the participants. Control group: sunflower seed oil was prepared and packaged by a cold press machine. People add 25 cc of sunflower seed oil daily to cold foods and consume for 7 weeks. A measuring spoon was provided to facilitate measurement by the participants. Interleukin-6. Timepoint: At baseline (before intervention) and 7 weeks after flaxseed or sunflower oil consumption. Method of measurement: using ELIZA kit (IBL International GMBH, Germany). Total antioxidant capacity. Timepoint: At baseline (before intervention) and 7 weeks after flaxseed or sunflower oil consumption. Method of measurement: using ELISA kit (ZellBio GMBH German). Prothrombin Time. Timepoint: At baseline (before intervention) and 7 weeks after flaxseed or sunflower oil consumption. Method of measurement: The Prothrombin Time (PT) test was performed by adding the plasma to thromboplastin that converts prothrombin to thrombin. The mixture was then kept in a warm water bath at 37°C for one or two minutes. Afterwards, calcium chloride was added to the mixture and allow clotting to start. The test was timed from the addition of calcium chloride until the plasma clotted. This time was called PT. Partial thromboplastin time. Timepoint: At baseline (before intervention) and 7 weeks after flaxseed or sunflower oil consumption. Method of measurement: In order to carry out Partial Thromboplastin Time (PTT) test, decalcified blood was used to prevent clotting before the test. At first, the plasma was separated via centrifugation. After that, ionized calcium and activating substances were added to the plasma. These substances included kaolin (hydrated aluminum silicate) and cephalin. The PTT refers to the time it takes for a clot to form, measured in seconds. Shiraz University of Medical Sciences Approved 2015-03-15 Ethics committee of Shiraz University of Medical Sciences the central building of Shiraz University of Medical Science, Emam Hosein Ave., Zand Blvd., Shiraz Town Shiraz Fars Iran (Islamic Republic of)