Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American University of Beirut Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-dose iron supplementation | Experimental | 195 mg iron as ferrous sulfate daily for 14 days |
|
| low-dose iron supplementation | Active Comparator | 15 mg iron as ferrous fumarate daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 195 mg iron daily | Dietary Supplement | 3 x 65 mg iron as ferrous sulfate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose increase during OGTT Day 0 | Blood glucose increase during OGTT before the intake of oral iron for 14 days | Day 0 |
| Blood glucose increase during OGTT Day 14 | Blood glucose increase during OGTT after the intake of oral iron for 14 days | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin increase during OGTT Day 0 | Insulin increase during OGTT before the intake of oral iron for 14 days | Day 0 |
| Insulin increase during OGTT Day 14 | Insulin increase during OGTT after the intake of oral iron for 14 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar Obeid | Contact | +961 1 350 000 | oo01@aub.edu.lb |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut | Recruiting | Beirut | Lebanon |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 15 mg iron daily |
| Dietary Supplement |
3 x 5 mg iron as ferrous sulfate |
|
| Day 14 |
| Serum Hepcidin Day 0 | Serum Hepcidin measured before the intake of oral iron | Day 0 |
| Serum Hepcidin D14 | Serum Hepcidin measured after the intake of oral iron | Day 14 |
| Serum Ferritin Day 0 | Serum Ferritin measured before the intake of oral iron | Day 0 |
| Serum Ferritin Day 14 | Serum Ferritin measured after the intake of oral iron | Day 14 |
| Soluble Transferrin Receptor (sTfR) Day 0 | sTfR measured before the intake of oral iron | Day 0 |
| Soluble Transferrin Receptor (sTfR) Day 14 | sTfR measured after the intake of oral iron | Day 14 |
| Hemoglobin Day 0 | Hemoglobin measured before the intake of oral iron | Day 0 |
| Hemoglobin Day 14 | Hemoglobin measured after the intake of oral iron | Day 14 |
| C-reactive protein (CRP) Day 0 | CRP measured before the intake of oral iron | Day 0 |
| C-reactive protein (CRP) Day 14 | CRP measured after the intake of oral iron | Day 14 |
| Alpha-1-acid glycoprotein (AGP) Day 0 | AGP measured before the intake of oral iron | Day 0 |
| Alpha-1-acid glycoprotein (AGP) Day 14 | AGP measured after the intake of oral iron | Day 14 |
| Serum Iron Day 0 | Serum Iron measured before the intake of oral iron | Day 0 |
| Serum Iron Day 14 | Serum Iron measured after the intake of oral iron | Day 14 |
| Total Iron Binding Capacity (TIBC) Day 0 | TIBC measured before the intake of oral iron | Day 0 |
| Total Iron Binding Capacity (TIBC) Day 14 | TIBC measured after the intake of oral iron | Day 14 |
| Transferrin Saturation (TSAT) Day 0 | TSAT measured before the intake of oral iron | Day 0 |
| Transferrin Saturation (TSAT) Day 14 | TSAT measured after the intake of oral iron | Day 14 |
| Transferrin Saturation (TSAT) Day 17 | TSAT measured at endpoint | Day 17 |
| Total Iron Binding Capacity (TIBC) Day 17 | TIBC measured at endpoint | Day 17 |
| Serum Iron Day 17 | Serum Iron measured at endpoint | Day 17 |
| Serum Hepcidin Day 17 | Serum Hepcidin measured at endpoint | Day 17 |
| Insulin increase during OGTT Day 17 | Insulin increase during OGTT at Endpoint | Day 17 |
| Blood glucose increase during OGTT Day 17 | Blood glucose increase during OGTT at Endpoint | Day 17 |
| Fasting blood glucose Day 0 | Fasting blood glucose before iron intake | Day 0 |
| Fasting blood glucose Day 14 | Fasting blood glucose after iron intake | Day 14 |
| Fasting blood glucose Day 17 | Fasting blood glucose at Endpoint | Day 17 |
| Fasting insulin Day 0 | Fasting insulin before iron intake | Day 0 |
| Fasting insulin Day 14 | Fasting insulin after iron intake | Day 14 |
| Fasting insulin Day 17 | Fasting insulin at Endpoint | Day 17 |
| Blood glucose profile measured over the 14 days | blood glucose profile measured by wearable FreeStyle Libre Sensor | Day 0 - Day 14 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |