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IRCT20181125041749N6 IRCT 2026-08-26 Alzahra University Effectiveness of Bee Pollen supplementation on hematological indices, iron stores, and aerobic performance in women with iron deficiency anemia Effectiveness of Bee Pollen supplementation on hematological indices, iron stores, and aerobic performance in women with iron deficiency anemia 2026-10-22 anticipated 28 Pending https://irct.ir/trial/92404 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to the study groups using simple randomization based on a random number table. The individual participant will be the unit of randomization. Eligible participants, after confirmation of the inclusion criteria and completion of the General Health Questionnaire and the Physical Activity Readiness Questionnaire (PAR-Q), will be randomly assigned to either the intervention group (bee pollen) or the control group (placebo), with 14 participants in each group. No stratified or cluster randomization will be used. The supplement and placebo capsules will be identical in appearance, and the group codes will remain confidential until completion of data analysis, after which they will be revealed. A third party will be aware of the capsule contents and group codes, Blinding description: The study will be conducted in a double-blind manner. Participants and the researchers conducting the assessments will be unaware of the participants’ group allocation and the contents of the capsules they receive. The bee pollen and placebo capsules will be identical in appearance. The group codes will remain confidential until completion of the data analysis and will then be revealed. Only a third party will be aware of the capsule contents and the corresponding group codes. N/A Iron deficiency anemia. Intervention 1: Intervention group: Participants will receive 1,600 mg of bee pollen orally per day (two 800-mg capsules) for 8 weeks, administered 30 minutes before the main breakfast and dinner meals. The bee pollen supplement will be obtained from Farvardin Company, Iran. Each capsule contains 800 mg of pure bee pollen. Intervention 2: Control group: Participants will receive two placebo capsules orally per day for 8 weeks, with each capsule containing 800 mg of wheat starch. The placebo capsules will be identical to the bee pollen capsules in appearance, color, and packaging. Yes - There is a plan to make this available What will be shared: Data relating to subjects will be shared as unidentified. When: Six months after the publication of the article. To whom: All researchers Conditions: The data may be used for citation purposes, provided that the source is acknowledged. Where to obtain: Fahimeh Kazemi How to obtain: By an Email Comments:
public Fahimeh Kazemi
Faculty of Physical Education and Sport Sciences, Alzahra University, Deh-e Vanak St.
Tehran Iran (Islamic Republic of) ۱۹۹۳۸۹۳۹۷۳ +98 21 8569 2689 f.kazemi@alzahra.ac.ir Alzahra University scientific Fahimeh Kazemi
Faculty of Physical Education and Sport Sciences, Alzahra University, Deh-e Vanak St.
Tehran Iran (Islamic Republic of) ۱۹۹۳۸۹۳۹۷۳ +98 21 8569 2689 f.kazemi@alzahra.ac.ir Alzahra University Iran (Islamic Republic of) Age 18–45 years Hemoglobin (Hb) level of 9–12 g/dL (mild to moderate anemia in non-pregnant women) Serum ferritin level below 30 ng/mL (depleted iron stores) No use of iron supplements, iron-containing multivitamins, or antioxidant supplements during the 4 weeks prior to the study No regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the 2 weeks prior to the study No history of hypersensitivity to bee products No history of chronic inflammatory, autoimmune, diabetic, hepatic, or renal diseases No hematological disorders other than iron deficiency anemia Not pregnant or breastfeeding No severe obesity (BMI <35 kg/m²) Willingness to participate and complete the 8-week study period 18 years 45 years Female History of hypersensitivity to bee products History of chronic inflammatory, autoimmune, diabetic, hepatic, or renal diseases Hematological disorders other than iron deficiency anemia Pregnancy or breastfeeding Severe obesity (BMI ≥ 35 kg/m²) Use of iron supplements, iron‑containing multivitamins, or antioxidant supplements during the 4 weeks prior to the study Regular use of nonsteroidal anti‑inflammatory drugs (NSAIDs) during the 2 weeks prior to the study Unwillingness to participate and complete the 8‑week study period Severe anemia (hemoglobin < 9 g/dL) or anemia due to other causes (hemoglobin > 12 g/dL) Inability to perform the exercise test due to musculoskeletal, cardiorespiratory, or coordination problems (based on test termination criteria such as dizziness, ataxia, severe hypotension, etc.) D50.9 Iron deficiency anemia, unspecified Treatment - Other N/A Intervention group: Participants will receive 1,600 mg of bee pollen orally per day (two 800-mg capsules) for 8 weeks, administered 30 minutes before the main breakfast and dinner meals. The bee pollen supplement will be obtained from Farvardin Company, Iran. Each capsule contains 800 mg of pure bee pollen. Control group: Participants will receive two placebo capsules orally per day for 8 weeks, with each capsule containing 800 mg of wheat starch. The placebo capsules will be identical to the bee pollen capsules in appearance, color, and packaging. Blood hemoglobin level. Timepoint: At baseline before the intervention and after 8 weeks of intervention. Method of measurement: Measurement of hemoglobin concentration in venous blood samples using a standard laboratory method. Red blood cell count (RBC). Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Measurement of red blood cell count in venous blood samples using an automated hematology analyzer. Blood hemoglobin level (Hb). Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Measurement of blood hemoglobin level in venous blood samples using an automated hematology analyzer. Hematocrit percentage (Hct). Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Measurement of hematocrit percentage in venous blood samples using an automated hematology analyzer. Serum ferritin level. Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Measurement of serum ferritin level in venous blood samples using a standard laboratory method. Serum iron level. Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Measurement of serum iron level in venous blood samples using a standard laboratory method. Transferrin saturation percentage (TSAT). Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Calculation of transferrin saturation percentage based on serum iron level and total iron-binding capacity. Total iron-binding capacity (TIBC). Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Measurement of total iron-binding capacity in venous blood samples using a standard laboratory method. Maximal oxygen consumption (VO2max). Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Estimation of maximal oxygen consumption using the Rockport One-Mile Walking Test. Time to complete the distance. Timepoint: At baseline, before the intervention, and after 8 weeks of intervention. Method of measurement: Measurement of the time required to complete one mile in the Rockport One-Mile Walking Test using a stopwatch. Alzahra University Approved 2026-07-01 Research Ethics Committees of Alzahra University Alzahra University, Deh-e-Vanak St. Tehran Tehran Iran (Islamic Republic of)