Investigating the effects of omega-3 supplementation compared to placebo on anthropometric measurements, thyroid hormone and anti-tpo concentrations, and systemic inflammation in patients with Hashimoto's disease.

Investigating the effects of taking omega-3 supplements on the concentration of thyroid hormones T4 and T3 and Anti-tpo and systemic inflammation (hs-crp) in patients with Hashimoto's disease

A phase 2 controlled, parallel-group, triple-blinded, randomized clinical trial on 60 patients. Randomization will be done using randomized blocks of size 4.

The Clinic of Nutrition Faculty of Shahid Beheshti University of Medical Sciences in Tehran is the host of this study on Hashimoto's thyroiditis patients. People will be divided into two groups of supplement and placebo and will receive supplement/placebo for 3 months. This study will be triple-blind and the participants will not be aware of the supplement or placebo they will be receiving. Two people will prepare the omega-3 supplement packets and the placebos, and steps will be taken to ensure participant confidentiality.

Inclusion criteria: Willingness to cooperate; suffering from Hashimoto's disease (endocrine specialist diagnosis); age of 20-70 years; Body mass index between 25-35. Exclusion criteria: pregnancy and breastfeeding; kidney Diseases; Following non-routine weight loss diets up to three months before the start of the study; taking anticoagulant, slimming and fat burning drugs, fiber powder; mineral, vegetable and fiber vitamin supplements; Presence of any blood clotting problems

Intervention group: Two 1000-mg omega-3 capsules per day with breakfast and dinner. Control group: Omega-3 placebo group: two 1000mg Omega-3 placebo (microcrystalline cellulose) capsules with breakfast and dinner.

Waist circumference; hips circumference; waist to hip ratio; body mass index; Triiodothyronine(T3); Thyroxine(T4);Thyroid Stimulating Hormone (TSH); Anti-thyroid peroxidase(Anti-TPO);High sensitivity C-reactive protein (hs-Crp)

In order to randomly divide people into two groups, first the patients are classified according to gender and the omega-3 group is marked with A and the placebo group is marked with B. Then, 13 blocks will be randomly selected from the table of blocks of size 4 that are combinations between A and B, and these blocks will be placed one after the other. Then 50 envelopes are prepared and the name of group A or B is placed in each envelope, so that the order of the envelopes is the same as the order of letters A and B in the selected blocks. Then the envelopes are opened in order and people are assigned to groups A and B. Omega 3 group people will receive 1000 mg of Omega 3 daily for 3 months and group B will receive a placebo that is completely similar in taste, color and appearance to Omega 3 supplements and contains sunflower oil.

In order to perform this research in a three blinded method, at the beginning of the study, the capsules containing omega-3 supplements or placebo are coded by the factory as A and B so that the lack of information of the researcher, statistical analyst and patients of the type of supplements received by each group is observed. .

Only part of the data is shared, such as the primary outcome.

The start of the access period is 12 months after printing the results.

It will be available for researchers working in academic and scientific institutions.

The documentation can only be used for more complete studies in this field.

Dr Golbon Sohrab Faculty member (assistant professor) at Faculty of Nutrition Sciences & Food Technology, Shaheed Beheshti University of Medical Sciences Email: golbonsohrab@sbmu.ac.ir

The communication will be possible through the electronic mail given in the previous section.