Effect of Astaxanthin supplementation on the insulin sensivity, lipid profile, and clinical symptoms in women with PCOS: A randomized clinical study

The primary objective of this trial is to investigate the effect of administration of 10 mg per day Astaxanthin (AST) for 12 weeks on clinical symptoms compared with control group in women with PCOS. Secondary aims are to determine the effect of 10 mg per day AST administration for 12 weeks on insulin sensitivity, lipid profile, circulating MDA level, and depression in women with PCOS.

Double-blind randomized clinical trial with parallel group, on 44 patients with concealed randomisation by Permuted Block Randomization method.

Eligible women with PCOS who refer to the collaborating gynecologist clinic Isfahan, Iran, in 2023–2024, will be recruited in this study. After explaining the objectives of the study, written informed consent will be obtained from all participants. All participants will have a project-specific code that will be used during all analyses of the data. We will use the SPIRIT reporting guidelines to describe this protocol.

Inclusion criteria: Eligible women with PCOS who refer to the collaborating gynecologist clinic Isfahan, Iran, in 2023–2024 Exclusion criteria: Pregnancy or breastfeeding, the presence of chronic inflammatory diseases, antioxidant supplementation intake in the last three months

Subjects in intervention group will receive one capsule congaing 10 mg AST per day made by "Zyest Technology Tarawat Zendig" institue in Iran. Subjects in placebo group will intake one capsule containing corn starch in a wrapped and covered form and appearance of AST supplementation.

Clinical symptoms Insulin sensitivity Lipid profile Circulating Malondialdehyde levels Depression

Patients will be randomly divided into 2 groups to receive astaxanthin supplement or placebo using the Permuted Block Randomization method. In this method, for selection of block size, we choose the block size 4 for this study (step1). For formation of blocks, participants are grouped into sets of four (step 2). For randomization within blocks within each block, randomization is performed using random number table. The key is that the treatment assignments within each block are randomly allocated (step 3). For balanced allocation, after randomizing the participants within a block, the number of participants assigned to each treatment group should be equal or as close to equal as possible (step 4). For the last step, steps 3 and 4 are repeated for each block of participants until all participants have been assigned to a treatment group.

In this study, the person who performs the blood test, the person who prescribes the supplements and participants do not know about the division of people into two drug and placebo groups. In this randomised trial, the person who analyzes the data (statistician) will generate allocation sequence, and assign participants to interventions randomly. Since the astaxanthin supplement and placebo are completely similar in terms of color and shape, patients are also not aware of this division. All baseline assessments will be undertaken prior to randomization and some assessments will be undertaken blinded for group allocation. All incoming data, including questionnaires and laboratory tests are collected by expert investigators in considered data sheets, and reviewed by the trial coordinator at the the Ethics Committee of Isfahan University of Medical Science to promote data quality. Both participants in AST and placebo groups are coded by the pharmaceutical company (code A and B). So, the investigators and participants will not be informed about allocation and the cods will be concealed until end of study.

There is no further information

The individual data of the participants in the study can be used without identifying names.

period of availability: from 1403

Researchers working in academic institutions

Data analysis is unimpeded.

Postal address for correspondence, or email address

Maximum 2 months