Overweight and Obese Women
Conditions
Brief 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. 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
Interventions
DIETARY_SUPPLEMENT195 mg iron daily
3 x 65 mg iron as ferrous sulfate
DIETARY_SUPPLEMENT15 mg iron daily
3 x 5 mg iron as ferrous sulfate
Sponsors
American University of Beirut Medical Center
Nicole Stoffel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose increase during OGTT Day 0 | Day 0 | Blood glucose increase during OGTT before the intake of oral iron for 14 days |
| Blood glucose increase during OGTT Day 14 | Day 14 | Blood glucose increase during OGTT after the intake of oral iron for 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin increase during OGTT Day 14 | Day 14 | Insulin increase during OGTT after the intake of oral iron for 14 days |
| Serum Hepcidin Day 0 | Day 0 | Serum Hepcidin measured before the intake of oral iron |
| Serum Hepcidin D14 | Day 14 | Serum Hepcidin measured after the intake of oral iron |
| Serum Ferritin Day 0 | Day 0 | Serum Ferritin measured before the intake of oral iron |
| Serum Ferritin Day 14 | Day 14 | Serum Ferritin measured after the intake of oral iron |
| Soluble Transferrin Receptor (sTfR) Day 0 | Day 0 | sTfR measured before the intake of oral iron |
| Soluble Transferrin Receptor (sTfR) Day 14 | Day 14 | sTfR measured after the intake of oral iron |
| Hemoglobin Day 0 | Day 0 | Hemoglobin measured before the intake of oral iron |
| Hemoglobin Day 14 | Day 14 | Hemoglobin measured after the intake of oral iron |
| C-reactive protein (CRP) Day 0 | Day 0 | CRP measured before the intake of oral iron |
| C-reactive protein (CRP) Day 14 | Day 14 | CRP measured after the intake of oral iron |
| Fasting blood glucose Day 14 | Day 14 | Fasting blood glucose after iron intake |
| Alpha-1-acid glycoprotein (AGP) Day 0 | Day 0 | AGP measured before the intake of oral iron |
| Alpha-1-acid glycoprotein (AGP) Day 14 | Day 14 | AGP measured after the intake of oral iron |
| Serum Iron Day 0 | Day 0 | Serum Iron measured before the intake of oral iron |
| Fasting blood glucose Day 17 | Day 17 | Fasting blood glucose at Endpoint |
| Total Iron Binding Capacity (TIBC) Day 0 | Day 0 | TIBC measured before the intake of oral iron |
| Total Iron Binding Capacity (TIBC) Day 14 | Day 14 | TIBC measured after the intake of oral iron |
| Transferrin Saturation (TSAT) Day 0 | Day 0 | TSAT measured before the intake of oral iron |
| Transferrin Saturation (TSAT) Day 14 | Day 14 | TSAT measured after the intake of oral iron |
| Transferrin Saturation (TSAT) Day 17 | Day 17 | TSAT measured at endpoint |
| Total Iron Binding Capacity (TIBC) Day 17 | Day 17 | TIBC measured at endpoint |
| Serum Iron Day 17 | Day 17 | Serum Iron measured at endpoint |
| Serum Hepcidin Day 17 | Day 17 | Serum Hepcidin measured at endpoint |
| Insulin increase during OGTT Day 17 | Day 17 | Insulin increase during OGTT at Endpoint |
| Blood glucose increase during OGTT Day 17 | Day 17 | Blood glucose increase during OGTT at Endpoint |
| Fasting blood glucose Day 0 | Day 0 | Fasting blood glucose before iron intake |
| Fasting insulin Day 0 | Day 0 | Fasting insulin before iron intake |
| Fasting insulin Day 14 | Day 14 | Fasting insulin after iron intake |
| Fasting insulin Day 17 | Day 17 | Fasting insulin at Endpoint |
| Blood glucose profile measured over the 14 days | Day 0 - Day 14 | blood glucose profile measured by wearable FreeStyle Libre Sensor |
| Serum Iron Day 14 | Day 14 | Serum Iron measured after the intake of oral iron |
| Insulin increase during OGTT Day 0 | Day 0 | Insulin increase during OGTT before the intake of oral iron for 14 days |
Countries
Lebanon
Contacts
Primary ContactOmar Obeid
Outcome results
None listed