American University of Beirut
Beirut, Lebanon
Location status: Recruiting
Recruiting
NCT Number: NCT07315282
The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women
The study will be a randomized, double-blind, 17-day metabolic intervention trial including 14 days of high-dose or low-dose iron supplementation. A total of 70 overweight or obese (OW/OB) women will be enrolled. Participants will be individually randomized into either the high-iron or low-iron group.
Women in the low-iron group will receive 15 mg of iron as ferrous fumarate daily for 14 days, while women in the high-iron group will receive 195 mg of iron as ferrous sulfate daily for 14 days.
The study consists of three visits in total. On Day 0, a fasting blood sample will be collected and an OGTT will be performed, with additional blood samples collected at 1 hour and 2 hours post-OGTT. The OGTT will be repeated on Day 14, after 14 days of oral iron supplementation, and again on Day 17, four days after oral iron supplementation has been stopped
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- BMI ≥ 27.5 kg/m2
- serum ferritin <30 μg/L
- hemoglobin ≥ 11 g/dl
- fasting blood glucose < 5.6 mmol/L
Exclusion criteria
- intravenous or high dose oral iron in the preceding 2 months
- medical disorders are known to affect iron absorption or metabolism, or T2DM
- cigarette smoking
- recent blood transfusion or major blood loss
Treatment and study plan
195 mg iron daily
Dietary Supplement3 x 65 mg iron as ferrous sulfate
15 mg iron daily
Dietary Supplement3 x 5 mg iron as ferrous sulfate
Primary outcomes
-
Blood glucose increase during OGTT Day 0
Time frame: Day 0
Blood glucose increase during OGTT before the intake of oral iron for 14 days
-
Blood glucose increase during OGTT Day 14
Time frame: Day 14
Blood glucose increase during OGTT after the intake of oral iron for 14 days
Secondary outcomes
-
Insulin increase during OGTT Day 0
Time frame: Day 0
Insulin increase during OGTT before the intake of oral iron for 14 days
-
Insulin increase during OGTT Day 14
Time frame: Day 14
Insulin increase during OGTT after the intake of oral iron for 14 days
-
Serum Hepcidin Day 0
Time frame: Day 0
Serum Hepcidin measured before the intake of oral iron
-
Serum Hepcidin D14
Time frame: Day 14
Serum Hepcidin measured after the intake of oral iron
-
Serum Ferritin Day 0
Time frame: Day 0
Serum Ferritin measured before the intake of oral iron
-
Serum Ferritin Day 14
Time frame: Day 14
Serum Ferritin measured after the intake of oral iron
-
Soluble Transferrin Receptor (sTfR) Day 0
Time frame: Day 0
sTfR measured before the intake of oral iron
-
Soluble Transferrin Receptor (sTfR) Day 14
Time frame: Day 14
sTfR measured after the intake of oral iron
-
Hemoglobin Day 0
Time frame: Day 0
Hemoglobin measured before the intake of oral iron
-
Hemoglobin Day 14
Time frame: Day 14
Hemoglobin measured after the intake of oral iron
-
C-reactive protein (CRP) Day 0
Time frame: Day 0
CRP measured before the intake of oral iron
-
C-reactive protein (CRP) Day 14
Time frame: Day 14
CRP measured after the intake of oral iron
-
Alpha-1-acid glycoprotein (AGP) Day 0
Time frame: Day 0
AGP measured before the intake of oral iron
-
Alpha-1-acid glycoprotein (AGP) Day 14
Time frame: Day 14
AGP measured after the intake of oral iron
-
Serum Iron Day 0
Time frame: Day 0
Serum Iron measured before the intake of oral iron
-
Serum Iron Day 14
Time frame: Day 14
Serum Iron measured after the intake of oral iron
-
Total Iron Binding Capacity (TIBC) Day 0
Time frame: Day 0
TIBC measured before the intake of oral iron
-
Total Iron Binding Capacity (TIBC) Day 14
Time frame: Day 14
TIBC measured after the intake of oral iron
-
Transferrin Saturation (TSAT) Day 0
Time frame: Day 0
TSAT measured before the intake of oral iron
-
Transferrin Saturation (TSAT) Day 14
Time frame: Day 14
TSAT measured after the intake of oral iron
-
Transferrin Saturation (TSAT) Day 17
Time frame: Day 17
TSAT measured at endpoint
-
Total Iron Binding Capacity (TIBC) Day 17
Time frame: Day 17
TIBC measured at endpoint
-
Serum Iron Day 17
Time frame: Day 17
Serum Iron measured at endpoint
-
Serum Hepcidin Day 17
Time frame: Day 17
Serum Hepcidin measured at endpoint
-
Insulin increase during OGTT Day 17
Time frame: Day 17
Insulin increase during OGTT at Endpoint
-
Blood glucose increase during OGTT Day 17
Time frame: Day 17
Blood glucose increase during OGTT at Endpoint
-
Fasting blood glucose Day 0
Time frame: Day 0
Fasting blood glucose before iron intake
-
Fasting blood glucose Day 14
Time frame: Day 14
Fasting blood glucose after iron intake
-
Fasting blood glucose Day 17
Time frame: Day 17
Fasting blood glucose at Endpoint
-
Fasting insulin Day 0
Time frame: Day 0
Fasting insulin before iron intake
-
Fasting insulin Day 14
Time frame: Day 14
Fasting insulin after iron intake
-
Fasting insulin Day 17
Time frame: Day 17
Fasting insulin at Endpoint
-
Blood glucose profile measured over the 14 days
Time frame: Day 0 - Day 14
blood glucose profile measured by wearable FreeStyle Libre Sensor
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Nicole Stoffel
Other
Collaborators
- American University of Beirut Medical Center
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 2, 2026
- Registry last updated
- Jan 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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