The effects of anti-inflammatory diet alone or in combination with acupuncture on mental health, advanced glycation end products (AGEs), anthropometric indices and metabolic status in diabetic patients with depression: A randomized, controlled clinical trial

1) Determination and comparison the effects of anti-inflammatory diet with/without acupuncture vs. control group on mental health (depression, anxiety) in diabetic patients with depression 2) Determination and comparison the effects of anti-inflammatory diet with/without acupuncture vs. control group on metabolic status (AGE, FBS, HbA1c, TC, TG, LDL-C, HDL-C, IL-6, hs-CRP) in diabetic patients with depression

Randomized controlled clinical trial

Eligible patients will be selected by the announcement and reffering by physicians among those referred to Diabetic clinics affiliated to Tehran University of Medical Sciences. Before starting the trial, the study will be explained to eligible individuals and if they have the tendency to participate, they will sign the written informed consent. Due to the type of intervention in this study, complete blindness is not possible. However, a colleague who will analysis data is not aware of the groups. Finally, encoded data will be provided to the data analysis team.

Inclusion criteria: suffering from T2DM for more than 6 months, taking oral anti-diabetic medications, and and suffering from mild-to-moderate depression. Exclusion criteria: injection insulin or liraglutide, taking medicinal herbs or herbal medicine, antibiotics, antioxidant supplements , suffering from severe depression, having chronic diseases, severe depression

(i) an individualized anti-inflammatory diet with acupuncture therapy, (ii) an individualized anti-inflammatory diet alone, (iii) common diet alone (control group).

mental health (depression, anxiety)

Eligible volunteers will be randomly allocated (1:1:1) into one of the three following groups: (i) receiving an individualized anti-inflammatory diet with acupuncture therapy (n=30), (ii) receiving an individualized anti-inflammatory diet alone (iii) receiving common diet (control group) (n=30). It is notable that volunteers will be randomized and allocated in each group based on the severity of depression (mild, moderate), age, and sex. The randomization will be carried out using an online system (https://www.sealedenvelope.com/). Once the randomization has been made, each patient is given a code with that she/he will be identified throughout the study. The randomization number will be assigned in a consecutive way. Randomization will not be exposed to those conducting the study and will be provided in sealed opaque envelopes with successive numbers. The envelope will be opened after signing the informed consent form and complying with the eligibility criteria by the patients.