The effect of propolis supplementation on athletic performance and inflammatory markers and oxidative stress

This clinical trial aims to assess the effect of propolis on oxidative stress status, inflammation, and exercise performance.

This study is a double-blind, placebo-controlled, randomized phase 2 clinical trial evaluating the effect of propolis on oxidative stress status, inflammation, and exercise performance. In this study, 54 eligible participants will be randomly assigned to either the intervention or the control group. The randomization sequence will be generated using a random-number table.

The study participants will be recruited from new cadets entering the Islamic Republic of Iran Army University of Medical Sciences. Participants who meet entry criteria will be randomly assigned to the propolis group or the placebo group. The participant's assignment will be concealed from all participants and investigators, with the exception of the study pharmacist and care provider.

The inclusion criteria are male sex, exerciser, age of 20 to 40 years, and body mass index of 18.5 to 25 kg/square meter. The exclusion criteria are cardiovascular diseases, diabetes, metabolic diseases, musculoskeletal dysfunction, sensitivity to propolis, and regular use of antioxidant supplements and anti-inflammatory drugs.

Participants in the intervention group will receive an identical propolis tablet (containing 450 mg Iranian green propolis extract and 150 mg microcrystalline cellulose) twice daily for 4 weeks. Participants in the placebo group will receive an identical tablet placebo (containing 590 mg microcrystalline cellulose and 10 mg edible colors) twice daily for 4 weeks.

Glutathione concentration Aerobic capacity Fatigue Index Anaerobic Power

Eligible participants will be randomly assigned, in a ratio of 1:1, to either propolis group or placebo group. Randomization will be stratified according to the participant's age (20-30 vs. 31-40 years). Randomization sequences will be prepared by the study's pharmacist with the use of a random number table.

Assignment of participants to the study groups will be concealed from participants and investigators, with the exception of the study pharmacist and care provider, until the end of the study and data analysis. The study pharmacist who will be aware of the assignments will prepared the placebo tablets similar to the propolis tablet in color, odor, taste, shape, size, and weight. Drug containers will be the same in terms of shape, color, odor, size, and weight and will be kept inside numbered, opaque, and sealed envelopes which will be completely impermeable to light.

The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.

The non-identifiable individual participant data will become available after the publication of the relevant articles.

The non-identifiable individual participant data will become available to other researchers in academic institutions.

The non-identifiable individual participant data can only be used for research.

The non-identifiable individual participant data will be obtainable by sending an e-mail to Mr. Said Hadi (s.hadinu@yahoo.com).

Other researchers in academic institutions can send their request by e-mail to Mr. Said Hadi (s.hadinu@yahoo.com). The data will be sent to them after consulting and approving the research team.