An interventional study of 195 mg iron daily and 15 mg iron daily in Overweight and Obese Women, sponsored by Nicole Stoffel. Recruiting at 1 site in Lebanon. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Nicole Stoffel · Not applicable, Interventional, and Other
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
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's planned enrollment of 70 is below the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Nicole Stoffel is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
195 mg iron as ferrous sulfate daily for 14 days
Dietary Supplement: 195 mg iron daily
15 mg iron as ferrous fumarate daily for 14 days
Dietary Supplement: 15 mg iron daily
3 x 65 mg iron as ferrous sulfate
3 x 5 mg iron as ferrous sulfate
Blood glucose increase during OGTT Day 0
Blood glucose increase during OGTT before the intake of oral iron for 14 days
Time frame: Day 0
Blood glucose increase during OGTT Day 14
Blood glucose increase during OGTT after the intake of oral iron for 14 days
Time frame: Day 14
Insulin increase during OGTT Day 0
Insulin increase during OGTT before the intake of oral iron for 14 days
Time frame: Day 0
Insulin increase during OGTT Day 14
Insulin increase during OGTT after the intake of oral iron for 14 days
Time frame: Day 14
Serum Hepcidin Day 0
Serum Hepcidin measured before the intake of oral iron
Time frame: Day 0
Serum Hepcidin D14
Serum Hepcidin measured after the intake of oral iron
Time frame: Day 14
Serum Ferritin Day 0
Serum Ferritin measured before the intake of oral iron
Time frame: Day 0
Serum Ferritin Day 14
Serum Ferritin measured after the intake of oral iron
Time frame: Day 14
Soluble Transferrin Receptor (sTfR) Day 0
sTfR measured before the intake of oral iron
Time frame: Day 0
Soluble Transferrin Receptor (sTfR) Day 14
sTfR measured after the intake of oral iron
Time frame: Day 14
Hemoglobin Day 0
Hemoglobin measured before the intake of oral iron
Time frame: Day 0
Hemoglobin Day 14
Hemoglobin measured after the intake of oral iron
Time frame: Day 14
C-reactive protein (CRP) Day 0
CRP measured before the intake of oral iron
Time frame: Day 0
C-reactive protein (CRP) Day 14
CRP measured after the intake of oral iron
Time frame: Day 14
Alpha-1-acid glycoprotein (AGP) Day 0
AGP measured before the intake of oral iron
Time frame: Day 0
Alpha-1-acid glycoprotein (AGP) Day 14
AGP measured after the intake of oral iron
Time frame: Day 14
Serum Iron Day 0
Serum Iron measured before the intake of oral iron
Time frame: Day 0
Serum Iron Day 14
Serum Iron measured after the intake of oral iron
Time frame: Day 14
Total Iron Binding Capacity (TIBC) Day 0
TIBC measured before the intake of oral iron
Time frame: Day 0
Total Iron Binding Capacity (TIBC) Day 14
TIBC measured after the intake of oral iron
Time frame: Day 14
Transferrin Saturation (TSAT) Day 0
TSAT measured before the intake of oral iron
Time frame: Day 0
Transferrin Saturation (TSAT) Day 14
TSAT measured after the intake of oral iron
Time frame: Day 14
Transferrin Saturation (TSAT) Day 17
TSAT measured at endpoint
Time frame: Day 17
Total Iron Binding Capacity (TIBC) Day 17
TIBC measured at endpoint
Time frame: Day 17
Serum Iron Day 17
Serum Iron measured at endpoint
Time frame: Day 17
Serum Hepcidin Day 17
Serum Hepcidin measured at endpoint
Time frame: Day 17
Insulin increase during OGTT Day 17
Insulin increase during OGTT at Endpoint
Time frame: Day 17
Blood glucose increase during OGTT Day 17
Blood glucose increase during OGTT at Endpoint
Time frame: Day 17
Fasting blood glucose Day 0
Fasting blood glucose before iron intake
Time frame: Day 0
Fasting blood glucose Day 14
Fasting blood glucose after iron intake
Time frame: Day 14
Fasting blood glucose Day 17
Fasting blood glucose at Endpoint
Time frame: Day 17
Fasting insulin Day 0
Fasting insulin before iron intake
Time frame: Day 0
Fasting insulin Day 14
Fasting insulin after iron intake
Time frame: Day 14
Fasting insulin Day 17
Fasting insulin at Endpoint
Time frame: Day 17
Blood glucose profile measured over the 14 days
blood glucose profile measured by wearable FreeStyle Libre Sensor
Time frame: Day 0 - Day 14
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for Jun 2026, 6 months later.
Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 6 months is below that.
Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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Nicole Stoffel