Overweight and Obese WomenNCT07315282
The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women
A study testing 195 mg iron daily and 15 mg iron daily in people with Overweight and Obese Women, run by Nicole Stoffel at 1 site in Lebanon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Overweight and Obese Women
- What is being tested?
- 195 mg iron daily and 15 mg iron daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteLebanon
- Study dates
- 23 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 27.5 kg/m2
- serum ferritin <30 μg/L
- hemoglobin ≥ 11 g/dl
- fasting blood glucose < 5.6 mmol/L
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut
Beirut
Omar Obeid, PhD, +961 1 350 000, oo01@aub.edu.lb
About this study
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
- Conditions
- Overweight and Obese Women
- Being tested
- 195 mg iron daily, 15 mg iron daily
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
195 mg iron dailyDietary supplement
3 x 65 mg iron as ferrous sulfate
15 mg iron dailyDietary supplement
3 x 5 mg iron as ferrous sulfate
| Study group | Role | What they receive |
|---|---|---|
| high-dose iron supplementation | Experimental | 195 mg iron as ferrous sulfate daily for 14 days Receives: Dietary Supplement: 195 mg iron daily |
| low-dose iron supplementation | Active comparator | 15 mg iron as ferrous fumarate daily for 14 days Receives: Dietary Supplement: 15 mg iron daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose increase during OGTT Day 0
Blood glucose increase during OGTT before the intake of oral iron for 14 days
Measured: Day 0
Blood glucose increase during OGTT Day 14
Blood glucose increase during OGTT after the intake of oral iron for 14 days
Measured: Day 14
Secondary outcomes (33)
Insulin increase during OGTT Day 0
Insulin increase during OGTT before the intake of oral iron for 14 days
Measured: Day 0
Insulin increase during OGTT Day 14
Insulin increase during OGTT after the intake of oral iron for 14 days
Measured: Day 14
Serum Hepcidin Day 0
Serum Hepcidin measured before the intake of oral iron
Measured: Day 0
Serum Hepcidin D14
Serum Hepcidin measured after the intake of oral iron
Measured: Day 14
Serum Ferritin Day 0
Serum Ferritin measured before the intake of oral iron
Measured: Day 0
Serum Ferritin Day 14
Serum Ferritin measured after the intake of oral iron
Measured: Day 14
Soluble Transferrin Receptor (sTfR) Day 0
sTfR measured before the intake of oral iron
Measured: Day 0
Soluble Transferrin Receptor (sTfR) Day 14
sTfR measured after the intake of oral iron
Measured: Day 14
Hemoglobin Day 0
Hemoglobin measured before the intake of oral iron
Measured: Day 0
Hemoglobin Day 14
Hemoglobin measured after the intake of oral iron
Measured: Day 14
C-reactive protein (CRP) Day 0
CRP measured before the intake of oral iron
Measured: Day 0
C-reactive protein (CRP) Day 14
CRP measured after the intake of oral iron
Measured: Day 14
Alpha-1-acid glycoprotein (AGP) Day 0
AGP measured before the intake of oral iron
Measured: Day 0
Alpha-1-acid glycoprotein (AGP) Day 14
AGP measured after the intake of oral iron
Measured: Day 14
Serum Iron Day 0
Serum Iron measured before the intake of oral iron
Measured: Day 0
Serum Iron Day 14
Serum Iron measured after the intake of oral iron
Measured: Day 14
Total Iron Binding Capacity (TIBC) Day 0
TIBC measured before the intake of oral iron
Measured: Day 0
Total Iron Binding Capacity (TIBC) Day 14
TIBC measured after the intake of oral iron
Measured: Day 14
Transferrin Saturation (TSAT) Day 0
TSAT measured before the intake of oral iron
Measured: Day 0
Transferrin Saturation (TSAT) Day 14
TSAT measured after the intake of oral iron
Measured: Day 14
Transferrin Saturation (TSAT) Day 17
TSAT measured at endpoint
Measured: Day 17
Total Iron Binding Capacity (TIBC) Day 17
TIBC measured at endpoint
Measured: Day 17
Serum Iron Day 17
Serum Iron measured at endpoint
Measured: Day 17
Serum Hepcidin Day 17
Serum Hepcidin measured at endpoint
Measured: Day 17
Insulin increase during OGTT Day 17
Insulin increase during OGTT at Endpoint
Measured: Day 17
Blood glucose increase during OGTT Day 17
Blood glucose increase during OGTT at Endpoint
Measured: Day 17
Fasting blood glucose Day 0
Fasting blood glucose before iron intake
Measured: Day 0
Fasting blood glucose Day 14
Fasting blood glucose after iron intake
Measured: Day 14
Fasting blood glucose Day 17
Fasting blood glucose at Endpoint
Measured: Day 17
Fasting insulin Day 0
Fasting insulin before iron intake
Measured: Day 0
Fasting insulin Day 14
Fasting insulin after iron intake
Measured: Day 14
Fasting insulin Day 17
Fasting insulin at Endpoint
Measured: Day 17
Blood glucose profile measured over the 14 days
blood glucose profile measured by wearable FreeStyle Libre Sensor
Measured: Day 0 - Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start23 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obese WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicole Stoffel
- Sponsor type
- University, hospital or other
- Collaborators
- American University of Beirut Medical Center
- Responsible party
- Sponsor-investigator, Nicole Stoffel, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315282
- Sponsor's protocol ID
- FIND
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Iron Supplements on Insulin and Glucose Metabolism in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT07315282
- Acronym / sponsor ID
- FIND
- Conditions
- Overweight and Obese Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nicole StoffelUniversity, hospital or other
- Collaborators
- American University of Beirut Medical Center
- Study start
- 23 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-dose iron supplementation | Experimental | Dietary Supplement: 195 mg iron daily195 mg iron as ferrous sulfate daily for 14 days |
| low-dose iron supplementation | Active comparator | Dietary Supplement: 15 mg iron daily15 mg iron as ferrous fumarate daily for 14 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI ≥ 27.5 kg/m2
- serum ferritin <30 μg/L
- hemoglobin ≥ 11 g/dl
- fasting blood glucose < 5.6 mmol/L
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 195 mg iron daily3 x 65 mg iron as ferrous sulfate | Dietary supplement | high-dose iron supplementation |
| 15 mg iron daily3 x 5 mg iron as ferrous sulfate | Dietary supplement | low-dose iron supplementation |
Primary outcome
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
33 secondary outcomes
Insulin increase during OGTT Day 0
Time frame: Day 0
Insulin increase during OGTT Day 14
Time frame: Day 14
Serum Hepcidin Day 0
Time frame: Day 0
Serum Hepcidin D14
Time frame: Day 14
Serum Ferritin Day 0
Time frame: Day 0
Serum Ferritin Day 14
Time frame: Day 14
Soluble Transferrin Receptor (sTfR) Day 0
Time frame: Day 0
Soluble Transferrin Receptor (sTfR) Day 14
Time frame: Day 14
Hemoglobin Day 0
Time frame: Day 0
Hemoglobin Day 14
Time frame: Day 14
C-reactive protein (CRP) Day 0
Time frame: Day 0
C-reactive protein (CRP) Day 14
Time frame: Day 14
Alpha-1-acid glycoprotein (AGP) Day 0
Time frame: Day 0
Alpha-1-acid glycoprotein (AGP) Day 14
Time frame: Day 14
Serum Iron Day 0
Time frame: Day 0
Serum Iron Day 14
Time frame: Day 14
Total Iron Binding Capacity (TIBC) Day 0
Time frame: Day 0
Total Iron Binding Capacity (TIBC) Day 14
Time frame: Day 14
Transferrin Saturation (TSAT) Day 0
Time frame: Day 0
Transferrin Saturation (TSAT) Day 14
Time frame: Day 14
Transferrin Saturation (TSAT) Day 17
Time frame: Day 17
Total Iron Binding Capacity (TIBC) Day 17
Time frame: Day 17
Serum Iron Day 17
Time frame: Day 17
Serum Hepcidin Day 17
Time frame: Day 17
Insulin increase during OGTT Day 17
Time frame: Day 17
Blood glucose increase during OGTT Day 17
Time frame: Day 17
Fasting blood glucose Day 0
Time frame: Day 0
Fasting blood glucose Day 14
Time frame: Day 14
Fasting blood glucose Day 17
Time frame: Day 17
Fasting insulin Day 0
Time frame: Day 0
Fasting insulin Day 14
Time frame: Day 14
Fasting insulin Day 17
Time frame: Day 17
Blood glucose profile measured over the 14 days
Time frame: Day 0 - Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 195 mg iron daily and 15 mg iron daily in people with Overweight and Obese Women, run by Nicole Stoffel at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Obeid (+961 1 350 000, oo01@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose increase during OGTT Day 0 (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.