Protocol summary

Study aim
To determine the effectiveness of bee pollen supplementation on hematological indices, iron stores, and aerobic performance in women with iron deficiency anemia
Design
Randomized, double blind, parallel-group clinical trial in women with iron deficiency anemia
Settings and conduct
Eligible participants will be randomly allocated to bee pollen or placebo groups. The intervention will be administered for 8 weeks, and hematological indices, iron stores, and aerobic performance will be assessed before and after the intervention. Participants and researchers conducting the assessments will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Women aged 18 to 45 years with iron deficiency anemia, hemoglobin 9 to 12 g/dL, and serum ferritin below 30 ng/mL; no use of iron supplements, iron containing multivitamins, or antioxidants during the previous 4 weeks; no regular use of nonsteroidal anti inflammatory drugs during the previous 2 weeks; no history of allergy to bee products; no chronic inflammatory, autoimmune, diabetic, hepatic, or renal disease; not pregnant or breastfeeding
Intervention groups
Intervention group: 1600 mg of bee pollen daily, two 800 mg capsules, for 8 weeks; Control group: two placebo capsules containing wheat starch daily for 8 weeks
Main outcome variables
Red blood cell count; blood hemoglobin level; hematocrit percentage; serum ferritin level; serum iron level; transferrin saturation percentage; total iron binding capacity; maximal oxygen consumption; time to complete the distance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181125041749N6
Registration date: 2026-08-26, 1405/06/04
Registration timing: prospective

Last update: 2026-08-26, 1405/06/04
Update count: 0
Registration date
2026-08-26, 1405/06/04
Registrant information
Name
Fahimeh Kazemi
Name of organization / entity
Alzahra University
Country
Iran (Islamic Republic of)
Phone
+98 21 8569 2689
Email address
kazemi.fahimeh@yahoo.de
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-10-22, 1405/07/30
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Bee Pollen supplementation on hematological indices, iron stores, and aerobic performance in women with iron deficiency anemia
Public title
Effectiveness of Bee Pollen supplementation on hematological indices, iron stores, and aerobic performance in women with iron deficiency anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Alzahra University
Street address
Alzahra University, Deh-e-Vanak St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Approval date
2026-07-01, 1405/04/10
Ethics committee reference number
IR.ALZAHRA.REC.1405.065

Health conditions studied

1

Description of health condition studied
Iron deficiency anemia
ICD-10 code
D50.9
ICD-10 code description
Iron deficiency anemia, unspecified

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

5

Description
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

6

Description
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

7

Description
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

8

Description
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

9

Description
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

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra University, Faculty of Sport Sciences
Full name of responsible person
Fahimeh Kazemi
Street address
Alzahra University, Deh-e Vanak St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2689
Email
f.kazemi@alzahra.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alzahra University
Full name of responsible person
Zahra Jafarzadeh
Street address
Alzahra University, Deh-e Vanak St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2202
Email
pr@alzahra.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alzahra University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Fahimeh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences, Alzahra University, Deh-e Vanak St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2689
Email
f.kazemi@alzahra.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Fahimeh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences, Alzahra University, Deh-e Vanak St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2689
Email
f.kazemi@alzahra.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Fahimeh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences, Alzahra University, Deh-e Vanak St.
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2689
Fax
Email
f.kazemi@alzahra.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data relating to subjects will be shared as unidentified.
When the data will become available and for how long
Six months after the publication of the article.
To whom data/document is available
All researchers
Under which criteria data/document could be used
The data may be used for citation purposes, provided that the source is acknowledged.
From where data/document is obtainable
Fahimeh Kazemi
What processes are involved for a request to access data/document
By an Email
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