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IRCT20130223012571N8 IRCT 2022-03-04 Yazd University of Medical Sciences The effect Pistacia Atlantica seed oil on serum antioxidant status in patients with metabolic syndrome The effect of blended canola and Pistacia Atlantica seed oil compared with blended canola and corn oil with and without synthetic antioxidant TBHQ on serum oxidant and antioxidant status markers in patients with metabolic syndrome 2022-05-21 anticipated 72 Complete https://irct.ir/trial/60665 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: The participants’ spouses will attend all visits of the study and also will provide blood samples. The blood samples will be aliquoted and frozen in the form of serum, Buffy coat, and whole blood and stored for further research. No analysis will be done on their specimen and data in the current study, Randomization description: As a randomized and cross-sectional three-way clinical trial, stratified block randomization will be used to assign participants for receiving the intervention oils. The stratification will be done based on sex and the block size will be 6. The participants in each block will be randomly assigned to one of the 6 sequences of rolling method in order to consume the three intervention oils during the study period: 1) blended canola-Pistacia Atlantica seed oil in phase 1, blended Canola-corn oil (with TBHQ) in phase 2, blended Canola-corn oil (without TBHQ) in phase 3; 2) blended canola-Pistacia Atlantica seed oil in phase 1, blended Canola-corn oil (without TBHQ) in phase 2, blended Canola-corn oil (with TBHQ) in phase 3; 3) blended Canola-corn oil (with TBHQ) in phase 1, blended Canola-corn oil (without TBHQ) in phase 2, blended canola-Pistacia Atlantica seed oil in phase 3; 4) blended Canola-corn oil (with TBHQ) in phase 1, blended canola-Pistacia Atlantica seed oil in phase 2, blended Canola-corn oil (without TBHQ) in phase 3; 5) blended Canola-corn oil (without TBHQ) in phase 1, blended Canola-corn oil (with TBHQ) in phase 2, blended canola-Pistacia Atlantica seed oil in phase 3; 6) blended Canola-corn oil (without TBHQ) in phase 1, blended canola-Pistacia Atlantica seed oil in phase 2, blended Canola-corn oil (with TBHQ) in phase 3. The randomized allocation will be done by n independent statistician using the statistical package for social sciences (SPSS) software. The randomization will be concealed from researchers by using opaque sealed envelopes, Blinding description: In this study, blinding will be done for treatment oils for participants, researchers, and statisticians. The intervention oils will be given in the same bottles and will be coded for each oil (canola-Pistacia Atlantica seed oil, Canola-corn oil (with TBHQ), Canola-corn oil (without TBHQ)) by an independent person who is not familiar with the study protocol and objectives. N/A Metabolic Syndrome. Intervention 1: Intervention phase: A blend of canola oil and Pistacia Atlantica seed oil (canola-Pistacia Atlantica seed oil). Intervention 2: Intervention phase: canola–corn oil with TBHQ. Intervention 3: Intervention phase: canola–corn oil without TBHQ. Yes - There is a plan to make this available What will be shared: We plan to register and deposit data that relates to individual primary publications and not the whole study database. this enables other researchers to replicate published analyses and results as well as to re-use the data for additional analyses such as meta-analysis. general characteristics (without the identity of the participants) as well as baseline and after-treatment data value of primary and secondary outcome variables, will become available for researchers after a request from interested investigators. When: Data will be available after the individual related papers become published. To whom: Data will become available for all investigators interested in the subject. Conditions: All efforts will be made to protect privacy and to de-identify the data. Therefore, data will be shared on request under the following conditions: -A meaningful study question by the requester; -Outline of the planned analyses; -Valid methodology; -signed data sharing agreement that contains a confidentiality agreement and approval of the study team members. Where to obtain: The data can be obtained from the principal investigator: Dr.Amin Salehi Abargouei, MSc, PhD in nutrition. department of nutrition faculty of public health shahid sadoughi university of Medical sciences Yazd, PO code 8915173160 Iran, Tel:+98-35-31492229, Fax:+98-35-38209119, Email: abargouei@ssu.ac.ir Alternate email:abargouei@gmail.com How to obtain: The interested investigators should provide a brief description of the data needed and their reason for asking for the data by contacting the principal investigator. He will assess the possibility of sharing the data and if applicable will ask for a signed data sharing agreement that contains a confidentiality agreement and approval of the study team members. Comments:
public Bahareh Sasanfar
Department of Nutrition, Faculty of Public Health, Shahid Sadoughi University of Medical Sciences, Alem square, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 bsasanfar@yahoo.com Yazd University of Medical Sciences scientific Amin Salehi-Abargouei
Department of Nutrition, Faculty of Public Health, Shahid Sadoughi University of Medical Sciences, Alem square, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 abargouei@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Adults aged 20-50 years Diagnosed with metabolic syndrome (having at least three of these conditions): abdominal obesity (waist circumference >102 cm in men and >88 cm in women), high blood pressure (systolic blood pressure >130 mmHg or diastolic blood pressure >85 mmHg), low serum high-density lipoprotein cholesterol (serum HDL cholesterol <40 mg/dl in men and <50 mg/dl in women), high serum triglycerides ( serum triglyceride > 150 mg/dl), high blood glucose (fasting blood glucose ≥ 100 mg/dl) 20 years 50 years Both Diagnosis or reporting a history of cardiovascular disease Diagnosis or reporting a history of diabetes mellitus Diagnosis or reporting a history of cancer Diagnosis or reporting a history of pancreatitis Diagnosis or reporting a history of liver disease Diagnosis or reporting a history of kidney disease Changing the blood sugar and lipid-lowering medications over the past three months Taking systemic corticosteroids, androgen, phenytoin, erythromycin, Hemostatic regulators (other than aspirin), gastrointestinal medicine less than 30 days before enrollment History of gastrointestinal disorders Alcohol use Being pregnant Intention to become pregnant Giving birth in the last 12 months Having allergy or intolerance to the intervention oils Reluctance to follow the study protocol Having weight change over 3 kg two months prior to the study Taking Omega-3 supplements more than 1 g/day Smoking more than 20 cigarettes a day Taking drugs for COVID-19 including remdesivir, Interferon, actemra, favipiravir in the last 3 months E88.81 Metabolic Syndrome Lifestyle Lifestyle Lifestyle Intervention phase: A blend of canola oil and Pistacia Atlantica seed oil (canola-Pistacia Atlantica seed oil) Intervention phase: canola–corn oil with TBHQ Intervention phase: canola–corn oil without TBHQ Serum total antioxidant capacity (TAC). Timepoint: Start and end of each intervention period. Method of measurement: IU/ml. Serum myeloperoxidase (MPO). Timepoint: Start and end of each intervention period. Method of measurement: ng/ml. Serum malondialdehyde (MDA). Timepoint: Start and end of each intervention period. Method of measurement: nmol to ml. Serum total oxidant status (TOS). Timepoint: Start and end of each intervention period. Method of measurement: IU/ml. Serum superoxide Dismutase (SOD). Timepoint: Start and end of each intervention period. Method of measurement: IU/ml. Serum catalase (CAT). Timepoint: Start and end of each intervention period. Method of measurement: IU/ml. Serum glutathione peroxidase (GPX). Timepoint: Start and end of each intervention period. Method of measurement: IU/ml. Serum glutathione reductase (GR). Timepoint: Start and end of each intervention period. Method of measurement: U/gr Hb. Serum nitric oxide (NO). Timepoint: Start and end of each intervention period. Method of measurement: Mm/ml. Fasting serum glucose. Timepoint: Start and end of each intervention period. Method of measurement: using appropriate kits. Serum triglycerides. Timepoint: Start and end of each intervention period. Method of measurement: mg/dL. Serum high density lipoprotein cholesterol (HDL-C). Timepoint: Start and end of each intervention period. Method of measurement: mg/dL. Systolic blood pressure. Timepoint: Start and end of each intervention period. Method of measurement: Barometer. Diastolic blood pressure. Timepoint: At the start and end of each intervention period. Method of measurement: Barometer. Body mass index (BMI). Timepoint: Start and end of each intervention. Method of measurement: kg/m2. Body fat percent. Timepoint: Start and end of each intervention. Method of measurement: Body composition analyzer. Body muscle percent. Timepoint: Start and end of each intervention. Method of measurement: Body composition analyzer. Body weight. Timepoint: Start and end of each intervention. Method of measurement: Body composition analyzer. Neshatavar Food Industry (DATIS) Yazd University of Medical Sciences Neshatavar Food Industry (DATIS) Approved 2021-11-23 Ethics committee of shahid sadoughi university of medical sciences Central building of shahid sadoughi university of medical sciences, bahonar square, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)