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

To investigate the effect of canola-Pistacia Atlantica seeds oil (a blend of canola and Pistacia Atlantica seed oils compared with canola–corn oil with TBHQ and canola–corn oil without TBHQ on serum oxidant and antioxidant status markers in patients with metabolic syndrome.

Three way randomized cross-over clinical trial

This study will be conducted at the school of Public health. all three oils will be provided in the same packages labeled by a person not aware of the study objectives. Participants and personnel will be blinded to the intervention oil.

Inclusion criteria: Males and females aged 20-50 years and with at least three of 5 metabolic syndrome conditions. Exclusion criteria: history of cardiovascular diseases, diabetes, cancer, liver, kidney, gastrointestinal disease, changing blood glucose and lipid profile control medications in previous 3 months, taking corticosteroids, androgens, phenytoin, erythromycin, hemostatic regulators (other than Asprin), and gastrointestinal medication in last 30 days, alcohol consumption, pregnancy, giving birth in last 12 months, smoking, omega-3 supplement use >1 g/day, severe weight change in previous 3 months, not willing to enter or follow the study protocol

Each intervention period (phase) will last 8 weeks. The participants will receive canola-Pistacia Atlantica seed oil, canola–corn oil (with TBHQ), and canola–corn oil (without TBHQ) in each intervention period. Intervention periods will be separated with 4 weeks of washout periods (sunflower oil will be provided).

Serum total antioxidant capacity, Total oxidant capacity, malondialdehyde, myeloperoxidase , superoxide dismutase , catalase , glutathione peroxidase, glutathione reductase, and nitric oxide levels

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.

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.

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.

Data will be available after the individual related papers become published.

Data will become available for all investigators interested in the subject.

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.

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

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.